|
1
|
Freitas AMI, Isaksson C, Rahkola-Soisalo P, Mentula M, Mikkola TS. Tension-Free Vaginal Tape versus Polyacrylamide Hydrogel Injection for Stress Urinary Incontinence - 5-Year Follow-Up. NEJM EVIDENCE 2025; 4:EVIDoa2400216. [PMID: 40261117 DOI: 10.1056/evidoa2400216] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 04/24/2025]
Abstract
BACKGROUND Tension-free vaginal tape has been the gold standard of treatment for female stress urinary incontinence, but concerns have risen about the safety of mesh. Transurethral injection of polyacrylamide hydrogel (PAHG) is a minimally invasive alternative. However, the long-term safety, efficacy, and patient satisfaction of PAHG is undefined. METHODS We conducted a randomized, controlled, noninferiority (margin 20%) trial at Helsinki University Hospital, Finland, comparing tension-free vaginal tape with PAHG treatment. The primary outcome was patient satisfaction. Secondary outcomes were effectiveness and complications. The results at 1 and 3 years have been previously reported. Herein, we report the 5-year follow-up. RESULTS Of the 223 women originally randomly assigned to a treatment group, 212 women underwent treatment as randomly assigned and, at 5 years, 195 (92.0%) women attended the follow-up. The median satisfaction score (visual analog scale: range, 0 to 100; higher scores indicated higher satisfaction) was 98 (interquartile range, 86 to 100) in the tension-free vaginal tape group, and 90 (interquartile range, 75 to 99) in the PAHG group, whereas a score of 80 or more was reached in 89 (92.7%) and 74 (74.7%) participants (difference, 18.0 percentage points; 95% confidence interval [CI], 7.7 to 28.0), respectively. Thus, PAHG did not meet the noninferiority criteria set in our trial. Within the 5-year follow-up, a peri- or postoperative complication before crossover between the groups was detected in 42 (43.8%) women in the tension-free vaginal tape group and 22 (22.2%) women in the PAHG group (difference, 21.5 percentage points; 95% CI, 8.4 to 33.8). CONCLUSIONS In long-term follow-up, treatment of stress urinary incontinence with PAHG was not noninferior to treatment with tension-free vaginal tape with respect to patient satisfaction scores. Complications were twice as common in the tension-free vaginal tape group. (Funded by Helsinki University Hospital and Contura; ClinicalTrials.gov number, NCT02538991.).
Collapse
Affiliation(s)
| | - Camilla Isaksson
- Department of Obstetrics and Gynecology, Helsinki University Hospital, Helsinki
| | | | - Maarit Mentula
- Department of Obstetrics and Gynecology, Helsinki University Hospital, Helsinki
| | - Tomi S Mikkola
- Department of Obstetrics and Gynecology, Helsinki University Hospital, Helsinki
| |
Collapse
|
|
2
|
Thuillier C, Meyer F, Campagne-Loiseau S, Bosset PO, Cardot V, Donon L, Even L, Girard F, Haddad R, Herve F, Hurel S, Klap J, Plassais C, Richard C, Thubert T, Vidart A, Cornu JN, Peyronnet B. Why should we stop implanting transobturator sling? THE FRENCH JOURNAL OF UROLOGY 2025:S2950-3930(25)00047-6. [PMID: 40250730 DOI: 10.1016/j.fjurol.2025.102900] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 04/09/2025] [Accepted: 04/12/2025] [Indexed: 04/20/2025]
Abstract
Since the first FDA warning on pelvic mesh in 2008, the debate on the use of synthetic polypropylene slings for the treatment of stress urinary incontinence (SUI) and pelvic organ prolapse (POP) has intensified. Despite the controversy, transvaginal tape (TVT) and transobturator tape (TOT) have revolutionized pelvic floor surgery. Systematic reviews and large trials confirm that synthetic slings, especially TVT, are safe and effective with low long-term complication and revision rates. Compared with older methods such as Burch colposuspension, slings offer similar efficacy but fewer voiding problems. While TOT is associated with a lower risk of bladder perforation and other intraoperative complications, it has a significantly higher incidence of chronic groin and pelvic pain. Emerging evidence links this pain to anatomical challenges, nerve entrapment and possible inflammatory responses, often making symptom resolution difficult even after mesh removal. In addition, the complete mesh removal is difficult in case of TOT, contributing to long-term patient morbidity. Given the higher re-operation rates, the prevalence of chronic pain, and the complex management associated with TOT, we argue for its discontinuation. TVT, despite its own risks, is more effective, reversible and manageable in the event of complications. Clinical focus should now shift to improving surgeon training, patient selection and postoperative care to optimise outcomes and minimise harm. LEVEL OF EVIDENCE: 3.
Collapse
Affiliation(s)
- Caroline Thuillier
- Department of Urology, 14(e) Hôpital Michallon, University of Grenoble, CHU Grenoble-Alpes, boulevard de la Chantourne, 38700 La Tronche, France.
| | - François Meyer
- Urology Department, Hôpital Saint-Louis, AP-HP, Paris, France
| | | | | | - Vincent Cardot
- Department of Urology, Clinique de Meudon-Clamart, 3, avenue de Villacoublay, 92360 Meudon, France
| | - Laurence Donon
- Department of Urology, Private Hospital Côte Basque Sud, Bayonne, France
| | - Lucie Even
- Department of Urology, Private Hospital Les Fleurs, La Seyne-sur-Mer, France
| | | | - Rebecca Haddad
- GRC 001, GREEN (Groupe de RecherchE cliniquE en Neuro-urologie), hôpital Tenon, Sorbonne université, AP-HP, Paris, France
| | - François Herve
- Department of Urology, Ghent University Hospital, Ghent, Belgium
| | - Sophie Hurel
- Department of Urology, Hôpital Européen Georges-Pompidou, AP-HP, Paris, France
| | - Julia Klap
- Urology Department, Hôpital Privé Claude-Galien, 91480 Quincy-sous-Senart, France
| | | | - Claire Richard
- Urology Department, University Hospital of Rennes, Rennes, France
| | - Thibault Thubert
- Department of Obstetrics and Gynaecology and Reproductive Medicine, Nantes University Hospital, Nantes, France
| | - Adrien Vidart
- Department of Urology, Hôpital Foch, 40, rue Worth, 92150 Suresnes, France
| | - Jean-Nicolas Cornu
- Service d'urologie, hôpital Charles-Nicolle, université de Rouen, 76000 Rouen, France
| | - Benoit Peyronnet
- Urology Department, University Hospital of Rennes, Rennes, France
| |
Collapse
|
|
3
|
Dogan O, Kadirogullari P, Comert EH, Basbug A, Yassa M. A randomized comparison of a single-incision needleless (Contasure-needleless®) mini-sling versus a mid-urethral sling (Contasure-KIM®): 60-month follow-up results. Eur J Obstet Gynecol Reprod Biol 2025; 307:7-12. [PMID: 39879743 DOI: 10.1016/j.ejogrb.2025.01.040] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/22/2024] [Revised: 01/08/2025] [Accepted: 01/24/2025] [Indexed: 01/31/2025]
Abstract
OBJECTIVES Mid-urethral sling (MUS) insertion is the gold standard approach to treat stress urinary incontinence (SUI) and adaptable single-incision mini-slings (SIMSs) aim to reduce complications. A previous study of our team has found that SIMSs were comparable to transobturator slings in cure rates after 24 months of follow-up. This study aims to compare the rates of cure, complications and re-intervention of both slings over a long-term follow-up of 5 years. STUDY DESIGN In this prospective trial, 179 women with SUI were randomly assigned to groups. A single surgeon performed all surgeries, and a blinded surgeon conducted 60-month follow-up exams. Objective and subjective cure was defined as a negative cough-stress test, and the absence of SUI based on ICIQ-SF, particularly. Failure was defined as the need for reoperation. RESULTS The 5-year subjective cure rates were comparable between TOT (75.0 %) and SIMS (65.8 %) groups (p = 0.281). Both groups exhibited decreased subjective cure rates from 24 to 60 months (p = 0.044 for TOT, p = 0.001 for SIMS). Mesh complication rates over 24 months were similar in TOT (7.9 %) and SIMS (6.8 %) groups (p = 0.528). Objective cure rates at 60 months were similar for both TOT (78.9 %) and SIMS (69.9 %) groups (p = 0.139). Reintervention for SUI was not significantly different between TOT (6.6 %) and SIMS (12.3 %) at 60 months (p = 0.098). CONCLUSION Single-incision needleless mini-slings showed similar cure rates to trans-obturator mid-urethral slings in 60-month follow-up. However, the objective cure rates decreased significantly from 24 to 60 months in the SIMS group (89.9 % to 69.9 %) compared to the TOT group (85.4 % to 78.9 %) (p = 0.002).
Collapse
Affiliation(s)
- Ozan Dogan
- Women's Health Clinic, Nişantası University, Department of Obstetrics and Gynecology, Pelvic Floor and Cosmetic Gynecology Association (PET-KOZ), Istanbul, Turkey
| | - Pinar Kadirogullari
- Acıbadem Atakent Hospital, Department of Obstetrics and Gynecology, Pelvic Floor and Cosmetic Gynecology Association (PET-KOZ), Istanbul, Turkey.
| | - Erhan Huseyin Comert
- Women's Health Clinic, Pelvic Floor and Cosmetic Gynecology Association (PET-KOZ), Istanbul, Turkey
| | - Alper Basbug
- Düzce University, Department of Obstetrics and Gynecology, Istanbul, Turkey
| | - Murat Yassa
- Acıbadem Kartal Hospital, Clinics of Obstetrics and Gynecology, Pelvic Floor and Cosmetic Gynecology Association (PET-KOZ), Istanbul, Turkey
| |
Collapse
|
|
4
|
Hillmeyer A, Kennes LN, Strauss M, Lube K, Stickeler E, Najjari L. The Impact of Pelvic Organ Prolapse on the Long-Term Outcomes of Transobturator Tape (TOT) Procedures-A Retrospective Study. J Clin Med 2024; 14:159. [PMID: 39797242 PMCID: PMC11721789 DOI: 10.3390/jcm14010159] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/18/2024] [Revised: 12/18/2024] [Accepted: 12/25/2024] [Indexed: 01/13/2025] Open
Abstract
Objectives: Transobturator tape (TOT) procedures are a widely used and effective treatment for stress urinary incontinence (SUI), but there is limited research on mesh-related complications and revision surgeries. This study aimed to evaluate the incidence of revision surgeries and mesh-related complications following TOT procedures and identify potential risk factors influencing these outcomes. Methods: This retrospective study analyzed data from patients who underwent TOT procedures at the specialized incontinence center of University Hospital Aachen (UHA), Germany, between January 2010 and May 2023. Patients were divided into three groups: initial surgery without revision, initial surgery with revision, and external referrals requiring revision. Statistical analyses included multivariate logistic regression and predictive cross-validation to identify risk factors for revision and mesh-related complications. Results: Out of 265 TOT procedures performed, the revision rate was 8.7%, and the mesh-related complication rate was 2.6%. Mesh complications, including erosion and wound dehiscence, accounted for 30% of revisions, while 70% of revisions were caused by recurrent stress urinary incontinence (SUI). External referrals showed longer revision intervals compared to UHA patients (53 months vs. 5 months; p = 0.003). Multivariate analysis identified rectoceles as a protective factor against revisions (p = 0.0414), while pre-existing conditions significantly increased revision risk (p = 0.0100). Conclusions: The revision rate following TOT procedures was 8.7%, with mesh-related complications accounting for 2.6%. Pre-existing conditions significantly increased the risk of revision, while rectoceles were associated with improved outcomes. These findings emphasize the importance of identifying patient-specific risk factors to enhance the safety and success of TOT procedures.
Collapse
Affiliation(s)
- Alessia Hillmeyer
- Department of Obstetrics and Gynecology, University Hospital RWTH Aachen, 52074 Aachen, Germany
| | - Lieven N. Kennes
- Department of Econometrics and Statistics, University Stralsund, 18435 Stralsund, Germany
| | - Mila Strauss
- Department of Obstetrics and Gynecology, University Hospital RWTH Aachen, 52074 Aachen, Germany
| | - Katharina Lube
- Department of Obstetrics and Gynecology, University Hospital RWTH Aachen, 52074 Aachen, Germany
| | - Elmar Stickeler
- Department of Obstetrics and Gynecology, University Hospital RWTH Aachen, 52074 Aachen, Germany
| | - Laila Najjari
- Department of Obstetrics and Gynecology, University Hospital RWTH Aachen, 52074 Aachen, Germany
| |
Collapse
|
|
5
|
Grilli D, Loggia M, Sala F, Palazzetti PL, Zullo MA, Luffarelli P, Spina V, Valensise HC, Schiavi MC. Combined treatment with vaginal native tissue repair plus mid-urethral sling or pelvic floor muscle training in patients with anterior defect and occult stress urinary incontinence: quality of life and sexual function analysis. Minerva Obstet Gynecol 2024; 76:492-500. [PMID: 37283533 DOI: 10.23736/s2724-606x.23.05289-2] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 06/08/2023]
Abstract
BACKGROUND The aim of this study was to compare the efficacy of vaginal native tissue repair (VNTR) combined with tension-free transobturator tape (TVT-O) or pelvic floor muscle training (PFMT) in terms of quality of life (QoL) and sexual function (SF) in women affected by anterior defect and occult stress urinary incontinence (OSUI). METHODS One hundred forty-seven patients with symptomatic anterior defect with OSUI underwent VNTR. In 71 patients TVT-O was inserted and 76 underwent PFMT after surgery. Clinical exam, 3-day voiding diary and urodynamic testing were evaluated in preoperative and postoperative times. Specific questionnaires were also administered, in order to indagate disease perception and the impact on QoL and SF. RESULTS Nine patients had postoperative pain in the TVT-O group vs. 0 patients in the PMFT group (P=0.001) and 7 patients reported de novo urgency vs. 3 in the two groups, respectively. At 12 weeks follow-up (FU), the first voiding desire was at 88.12+19.70 mL in VNTR+TOT vs. 102.29+19.13 (P=0.03); the mean number of voids (24 hours) was 9.95±2.66 vs. 6.14±1.77 (P=0.04), respectively. No significant differences in terms of QoL and SF were shown. CONCLUSIONS This retrospective study suggests that VNTR+TVT-O and VNTR+PMFT have the same efficacy in terms of QoL and SF, with several post-operative complications, even if minor, in patients treated with combined surgery.
Collapse
Affiliation(s)
- Debora Grilli
- Department of Obstetrics and Gynecology, Sandro Pertini Hospital, Rome, Italy
- Department of Obstetrics and Gynecology, Tor Vergata University, Rome, Italy
| | - Melania Loggia
- Department of Obstetrics and Gynecology, Sandro Pertini Hospital, Rome, Italy -
- Department of Obstetrics and Gynecology, Tor Vergata University, Rome, Italy
| | - Federica Sala
- Department of Obstetrics and Gynecology, Sandro Pertini Hospital, Rome, Italy
- Department of Obstetrics and Gynecology, Tor Vergata University, Rome, Italy
| | - Pier L Palazzetti
- Department of Obstetrics and Gynecology, Sandro Pertini Hospital, Rome, Italy
| | - Marzio A Zullo
- Department of Surgery-Week Surgery, Campus Biomedico University, Rome, Italy
| | - Paolo Luffarelli
- Department of Surgery-Week Surgery, Campus Biomedico University, Rome, Italy
| | - Vincenzo Spina
- Unit of Protection of Maternal and Child Health, Rieti, Italy
| | - Herbert C Valensise
- Department of Obstetrics and Gynecology, Tor Vergata University, Rome, Italy
- Department of Obstetrics and Gynecology, Casilino Hospital, Rome, Italy
| | - Michele C Schiavi
- Department of Obstetrics and Gynecology, Sandro Pertini Hospital, Rome, Italy
| |
Collapse
|
|
6
|
Farag F, Osman NI, Pang KH, Castro-Diaz D, Chapple CR, Cruz F, Gamé X, Goldman H, Greenwell T, Hampel C, Scailteux LM, Roovers JP, Welk B, Heesakkers J. Complications of Synthetic Midurethral Slings: Is There a Relevant Discrepancy Between Observational Data and Clinical Trials? Eur Urol Focus 2024; 10:535-550. [PMID: 37973453 DOI: 10.1016/j.euf.2023.11.002] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/31/2023] [Revised: 09/24/2023] [Accepted: 11/03/2023] [Indexed: 11/19/2023]
Abstract
CONTEXT The complications of synthetic midurethral slings (MUSs) in women with stress urinary incontinence (SUI) have become a globally debated issue. OBJECTIVE To systematically review the short- and long-term complications of mesh slings reported in observational data compared with clinical trial data, to determine whether the complication rates from clinical trials reflects "real-world" observational data. EVIDENCE ACQUISITION PubMed and Cochrane Library were searched. Methods as detailed in Preferred Reporting Items for Systematic Reviews and Meta-analyses and Cochrane Handbook for Systematic Reviews of Interventions were followed. EVIDENCE SYNTHESIS Thirty registries/databases including 709 335 MUS procedures (1-22 yr of follow-up) were identified. MUS procedures were associated with intraoperative bladder perforation in 0.86-3.6%, urethral perforation in 0-0.1%, vascular injury in 0.04-0.1%, voiding lower urinary tract symptoms (LUTS) in 1.47-3.5%, vaginal exposure in 0.2-1.9%, and reoperation in up to 9% of cases. Forty-three randomised clinical trials were identified, including 6284 women who underwent MUS procedures and 2177 women who underwent other interventions (1-10 yr of follow-up). MUS procedures were associated with urinary tract perforation in 2.58%, vaginal injury in 1.43%, de novo voiding LUTS in 4.37%, de novo storage LUTS in 5.41%, mesh extrusion/exposure (vaginal/urinary tract) in 2.54%, dyspareunia in 2.26%, pain (pelvic/suprapubic/perineal) in 2.83%, and reoperation for complications required in 1.82% of cases. Meta-analyses of the randomised controlled trials revealed that retropubic MUSs were associated with more events of urinary tract perforation (risk ratio [RR] 9.81, 95% confidence interval [CI] 5.05-19.04, high certainty of evidence [COE]) and voiding LUTS (RR 1.57, 95% CI 1.19-2.07, high COE) than transobturator MUSs. MUSs were associated with more events of pain than mini-slings (RR 1.72, 95% CI 1.04-2.87, moderate COE). CONCLUSIONS Short- and long-term data on complications of polypropylene mesh used for female SUI are fairly comparable when using outcome data from well-designed clinical trials or from less structured prospective or retrospective registries. Comparisons have to be made with caution since the two systems of data collection are inherently incomparable. This knowledge should be incorporated in the discussion on how to implement polypropylene mesh for female stress incontinence. PATIENT SUMMARY In order to know whether mesh tapes used for treating stress incontinence work well and are safe, high-quality information is important. It appears that well-designed clinical studies give similar results to large registration databases. These data should be interpreted with caution in view of the different ways the information was collected. These results will help physicians and patients understand the risks of mesh tapes.
Collapse
Affiliation(s)
| | - N I Osman
- Royal Hallamshire Hospital, Sheffield, UK
| | - K H Pang
- Royal Hallamshire Hospital, Sheffield, UK
| | - D Castro-Diaz
- Hospital Universitario de Canarias/Universidad de La Laguna, La Laguna, Spain
| | - C R Chapple
- Sheffield Teaching Hospitals NHS Foundation Trust, University of Sheffield, Sheffield, UK
| | - F Cruz
- Faculty of Medicine of University of Porto, i3S institute and Hospital São João, Porto, Portugal
| | - X Gamé
- Département d'Urologie, Transplantation Rénale et Andrologie, CHU Rangueil, Toulouse, France
| | - H Goldman
- Glickman Urologic and Kidney Institute, Cleveland Clinic, Lerner College of Medicine, Cleveland, OH, USA
| | - T Greenwell
- University College London Hospitals, London, UK
| | - C Hampel
- Urologische Abteilung, Marien-Hospital Erwitte, Erwitte, Germany; Neuro-Urologie/Urologie Universitätsklinikum Bonn und Neuro-Urologie, Neurologisches Rehabilitationszentrum der Godeshöhe e. V., Bonn, Germany
| | - L M Scailteux
- Pharmacovigilance, Pharmacoepidemiology and Drug Information Centre, Department of Clinical Pharmacology, Rennes University Hospital, Rennes, France
| | - J P Roovers
- Department of Obstetrics and Gynaecology, Amsterdam University Medical Center, Amsterdam, The Netherlands
| | - B Welk
- Division of Urology, Department of Surgery, Western University, London, Ontario, Canada
| | - J Heesakkers
- Maastricht University Medical Center, Maastricht, The Netherlands
| |
Collapse
|
|
7
|
Perrouin‐Verbe M, Ochoa D, Skews R, Acharya M, Prouza A, Hashim H. Quality of life outcomes after transobturator tape full removal surgeries: A monocentric experience. BJUI COMPASS 2024; 5:454-464. [PMID: 38751946 PMCID: PMC11090767 DOI: 10.1002/bco2.317] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/14/2023] [Accepted: 11/13/2023] [Indexed: 05/18/2024] Open
Abstract
Objective The objective of this study is to describe a standardised technique of full TOT removal with groin dissection and to report clinical improvement, satisfaction, safety and long-term functional, quality of life (QoL) and sexual QoL outcomes. Materials and methods A retrospective review enrolling all women who had full TOT removal, in a tertiary referral centre from May 2017 to November 2020. Functional outcomes, satisfaction and QoL were assessed using a bespoke composite questionnaire (UDI-6, EQ-5D-5L and ICIQ-S) with additional questions on sexual QoL. Secondary outcomes were post-operative recurrent stress urinary incontinence (SUI) and complication rate according to the Clavien-Dindo classification. Results Full TOT removal using a vaginal approach and bilateral groin/para-labial incisions was performed in 67 patients. Chronic pelvic pain was the main indication for mesh removal (51% of cases, n = 34). QoL questionnaires were answered by 43 patients. The satisfaction rate was high 86% (n = 37), and 81% (n = 35) of the patients considered the surgery successful. Seventy per cent (n = 30) of patients returned to having a sexual life after surgery. Recurrent SUI was reported in 32% (n = 14) of cases. The complication rate was 10% (7/67), all of them Clavien-Dindo ≤2. Conclusion Despite a high rate of postoperative bothersome SUI, full TOT removal with bilateral groin dissection improves pain and QoL. It is associated with a high overall satisfaction rate and an acceptable rate of complications.
Collapse
Affiliation(s)
| | | | - Rachel Skews
- Bristol Urological InstituteSouthmead HospitalBristolUK
| | - Mez Acharya
- Department of Trauma and Orthopaedic SurgerySouthmead HospitalBristolUK
| | | | - Hashim Hashim
- Bristol Urological InstituteSouthmead HospitalBristolUK
| |
Collapse
|
|
8
|
Armengaud C, Fauconnier A, Drioueche H, Campagne Loiseau S, De Tayrac R, Saussine C, Panel L, Cosson M, Deffieux X, Lucot JP, Pizzoferrato AC, Ferry P, Vidart A, Thubert T, Capon G, Debodinance P, Gauthier T, Koebele A, Salet-Lizee D, Hermieu JF, Game X, Ramanah R, Lamblin G, Lecornet E, Carlier-Guérin C, Chartier-Kastler E, Fritel X. Serious complications and recurrences after retropubic vs transobturator midurethral sling procedures for 2682 patients in the VIGI-MESH register. Am J Obstet Gynecol 2024; 230:428.e1-428.e13. [PMID: 38008151 DOI: 10.1016/j.ajog.2023.11.1241] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/11/2023] [Revised: 11/07/2023] [Accepted: 11/21/2023] [Indexed: 11/28/2023]
Abstract
BACKGROUND Midurethral slings are the gold standard for treating stress urinary incontinence, but their complications may raise concerns. Complications may differ by the approach used to place them. OBJECTIVE This study aimed to compare serious complications and reoperations for recurrence after midurethral sling procedures when using the retropubic vs the transobturator route for female stress urinary incontinence. STUDY DESIGN This analysis was of patients included in the French, multicenter VIGI-MESH register since February 2017 who received a midurethral sling for female stress urinary incontinence either by the retropubic or the transobturator route and excluded patients with single-incision slings. Follow-up continued until October 2021. Serious complications (Clavien-Dindo classification ≥ grade III) attributable to the midurethral sling and reoperations for recurrence were compared using Cox proportional hazard models including any associated surgery (hysterectomy or prolapse) and a frailty term to consider the center effect. Baseline differences were balanced by propensity score weighting. Analyses using the propensity score and Cox models were adjusted for baseline differences, center effect, and associated surgery. RESULTS A total of 1830 participants received a retropubic sling and 852 received a transobturator sling in 27 French centers that were placed by 167 surgeons. The cumulative 2-year estimate of serious complications was 5.8% (95% confidence interval, 4.8-7.0) in the retropubic group and 2.9% (95% confidence interval, 1.9-4.3) in the transobturator group, that is, after adjustment, half of the retropubic group was affected (adjusted hazard ratio, 0.41; 95% confidence interval, 0.3-0.6). The cumulative 2-year estimate of reoperation for recurrence of stress urinary incontinence was 2.7% (95% confidence interval, 2.0-3.6) in the retropubic group and 2.8% (95% confidence interval, 1.7-4.2) in the transobturator group with risk for revision for recurrence being higher in the transobturator group after adjustment (adjusted hazard ratio, 1.9; 95% confidence interval, 1.2-2.9); this surplus risk disappeared after exclusion of the patients with a previous surgery for stress urinary incontinence. CONCLUSION The transobturator route for midurethral sling placement is associated with a lower risk for serious complications but a higher risk for surgical reoperation for recurrence than the retropubic route. Despite the large number of surgeons involved, these risks were low. The data are therefore reassuring.
Collapse
Affiliation(s)
- Camille Armengaud
- Service de Gynécologie-Obstétrique, CHI Poissy-St-Germain, Poissy, France.
| | - Arnaud Fauconnier
- Université Paris-Saclay, UVSQ, Unité de recherche 7285 "Risques cliniques et sécurité en santé des femmes et en santé périnatale" (RISCQ), Montigny-le-Bretonneux, Service de Gynécologie-Obstétrique, CHI Poissy-Saint-Germain, Poissy, France
| | - Hocine Drioueche
- Service de Gynécologie-Obstétrique, CHI Poissy-St-Germain, Poissy, France
| | | | - Renaud De Tayrac
- Service de Gynécologie-Obstétrique, CHU Carémeau, Nîmes, Université de Montpellier, Montpellier, France
| | - Christian Saussine
- Service d'urologie, CHU de Strasbourg, Université de Strasbourg, Strasbourg, France
| | - Laure Panel
- Service de Gynécologie, Clinique Beau-Soleil, Montpellier, France
| | - Michel Cosson
- Service de Gynécologie-Obstétrique, CHU de Lille, Université de Lille, Lille, France
| | - Xavier Deffieux
- Service de Gynécologie-Obstétrique, APHP Antoine-Béclère, Université Paris-Sud, Clamart, France
| | - Jean Philippe Lucot
- Service de Gynécologie-Obstétrique, Hôpital Saint-Vincent-de-Paul, Lille, France; Groupe des hôpitaux de l'institut catholique de Lille (GHICL), Lille, France
| | - Anne Cécile Pizzoferrato
- Service de Gynécologie-Obstétrique et Médecine de la Reproduction, CHU de Poitiers, Poitiers, France; Faculté de Médecine et Pharmacie, Université de Poitiers, Inserm CIC, France
| | - Philippe Ferry
- Service de Gynécologie-Obstétrique, CH de La Rochelle, La Rochelle, France
| | | | - Thibault Thubert
- Service de Gynécologie, CHU de Nantes, Centre d'investigation clinique, CHU de Nantes, Laboratoire Motricité, Interactions, Performances (MIP) - UR 4334 - UFR STAPS - Nantes Université, Nantes, France
| | | | | | - Tristan Gauthier
- Service de Gynécologie-Obsétrique, Hôpital Mère-Enfant, CHU Limoges, Limoges, France
| | - Antoine Koebele
- Service de Gynécologie, Maternité régionale universitaire, Nancy, France
| | - Delphine Salet-Lizee
- Groupe Hospitalier Diaconesses-Croix-Saint-Simon, Service de gynécologie, Paris, France
| | | | - Xavier Game
- Service d'urologie, CHU Rangueil, Toulouse, France
| | | | - Gery Lamblin
- Service de Gynécologie-Obstétrique, Hôpital Femme-Mère-Enfant, Hospices civils de Lyon, Lyon, France
| | - Emilie Lecornet
- Service d'urologie, Polyclinique d'Hénin Beaumont, Groupe AHNAC, Henin-Beaumont, France
| | | | | | - Xavier Fritel
- Faculté de Médecine et Pharmacie, Université de Poitiers, Inserm CIC 1402, Service de Gynécologie-Obstétrique et Médecine de la Reproduction, CHU de Poitiers, Poitiers, France
| |
Collapse
|
|
9
|
Brasoveanu S, Ilina R, Balulescu L, Pirtea M, Secosan C, Grigoraș D, Olaru F, Erdelean D, Balint O, Margan MM, Ivan CS, Pirtea L. Evaluating Patient Preferences and Clinical Outcomes in Stress Urinary Incontinence Treatment: A Short-Term Follow-Up Study of the Transobturator Tape Procedure and Pubourethral Ligament Plication (a Minimally Invasive Technique). J Pers Med 2023; 14:34. [PMID: 38248735 PMCID: PMC10817340 DOI: 10.3390/jpm14010034] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/08/2023] [Revised: 12/24/2023] [Accepted: 12/24/2023] [Indexed: 01/23/2024] Open
Abstract
OBJECTIVE This study aims to provide an in-depth analysis of patient preferences and clinical outcomes associated with two surgical techniques for treating stress urinary incontinence (SUI): the transobturator suburethral sling (TOT) procedure and the pubourethral ligament plication (PUL) procedure. We evaluated the rates of postoperative complications, the duration of each procedure, hemoglobin loss, and days of hospitalization. MATERIALS AND METHODS This prospective study included 80 patients who underwent surgery for SUI: 40 patients for the TOT procedure and 40 patients for the PUL procedure. Clinical data on patient characteristics, treatment efficacy, and post-surgical outcomes were analyzed to assess patient preferences and real-world clinical effectiveness. RESULTS Regarding patient preferences, those who underwent TOT surgery were more likely to be older, had a higher average number of pregnancies, and were more often postmenopausal, in contrast to those who underwent PUL surgery (p < 0.001 for each comparison). TOT patients had a hospital stay on average of 1.02 days, while PUL patients benefited from ambulatory stays only. In addition, the TOT group had a significantly longer average operating time (16.80 min) compared to the PUL group (9.90 min, p < 0.001). The study revealed notable outcomes in both groups, with high cure rates for both TOT (N1 = 33, 82.5%) and PUL (N2 = 28, 70%) procedures. Specifically, 76.25% of the patients (61 out of 80) were cured after the procedures. Chronic pelvic pain was present in 3.75% of all patients and was notably only observed in the TOT group, with 3 (7.5%) cases being noted. Similarly, vaginal erosion was experienced by 5% of all patients, with 10% of patients in the TOT group and none in the PUL group being affected. Dyspareunia occurred in 2.5% of all patients, with there being two (5%) cases in the TOT group and none in the PUL group. CONCLUSIONS This study highlights that while the PUL procedure achieves cure rates comparable to TOT, it offers a less invasive option with shorter operating times and no hospitalization required. These findings suggest that PUL could be a viable alternative for stress urinary incontinence (SUI) treatment, especially in contexts where avoiding mesh use is preferred. This adds significant value to patient-centered care in SUI management, offering tailored treatment options based on patient characteristics, preferences, and risk profiles.
Collapse
Affiliation(s)
- Simona Brasoveanu
- Department of Obstetrics and Gynecology, Victor Babes University of Medicine and Pharmacy, 300041 Timisoara, Romania; (S.B.); (L.B.); (M.P.); (C.S.); (D.G.); (F.O.); (D.E.); (O.B.); (L.P.)
| | - Răzvan Ilina
- Department of Surgery, Discipline of Surgical Semiology II, Victor Babes University of Medicine and Pharmacy, 300041 Timisoara, Romania
| | - Ligia Balulescu
- Department of Obstetrics and Gynecology, Victor Babes University of Medicine and Pharmacy, 300041 Timisoara, Romania; (S.B.); (L.B.); (M.P.); (C.S.); (D.G.); (F.O.); (D.E.); (O.B.); (L.P.)
| | - Marilena Pirtea
- Department of Obstetrics and Gynecology, Victor Babes University of Medicine and Pharmacy, 300041 Timisoara, Romania; (S.B.); (L.B.); (M.P.); (C.S.); (D.G.); (F.O.); (D.E.); (O.B.); (L.P.)
| | - Cristina Secosan
- Department of Obstetrics and Gynecology, Victor Babes University of Medicine and Pharmacy, 300041 Timisoara, Romania; (S.B.); (L.B.); (M.P.); (C.S.); (D.G.); (F.O.); (D.E.); (O.B.); (L.P.)
| | - Dorin Grigoraș
- Department of Obstetrics and Gynecology, Victor Babes University of Medicine and Pharmacy, 300041 Timisoara, Romania; (S.B.); (L.B.); (M.P.); (C.S.); (D.G.); (F.O.); (D.E.); (O.B.); (L.P.)
| | - Flavius Olaru
- Department of Obstetrics and Gynecology, Victor Babes University of Medicine and Pharmacy, 300041 Timisoara, Romania; (S.B.); (L.B.); (M.P.); (C.S.); (D.G.); (F.O.); (D.E.); (O.B.); (L.P.)
| | - Dragos Erdelean
- Department of Obstetrics and Gynecology, Victor Babes University of Medicine and Pharmacy, 300041 Timisoara, Romania; (S.B.); (L.B.); (M.P.); (C.S.); (D.G.); (F.O.); (D.E.); (O.B.); (L.P.)
| | - Oana Balint
- Department of Obstetrics and Gynecology, Victor Babes University of Medicine and Pharmacy, 300041 Timisoara, Romania; (S.B.); (L.B.); (M.P.); (C.S.); (D.G.); (F.O.); (D.E.); (O.B.); (L.P.)
| | - Mădălin-Marius Margan
- Department of Functional Sciences, Discipline of Public Health, Victor Babes University of Medicine and Pharmacy, 300041 Timisoara, Romania;
| | - Cristiana-Smaranda Ivan
- General Medicine, Victor Babes University of Medicine and Pharmacy, 300041 Timisoara, Romania;
| | - Laurențiu Pirtea
- Department of Obstetrics and Gynecology, Victor Babes University of Medicine and Pharmacy, 300041 Timisoara, Romania; (S.B.); (L.B.); (M.P.); (C.S.); (D.G.); (F.O.); (D.E.); (O.B.); (L.P.)
| |
Collapse
|
|
10
|
Zhang S, Liu J, Hong S, Yang L, Li H, Hong L. Bibliometric analysis of studies on stress urinary incontinence surgery. Heliyon 2023; 9:e21833. [PMID: 38027971 PMCID: PMC10663906 DOI: 10.1016/j.heliyon.2023.e21833] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/01/2023] [Revised: 10/27/2023] [Accepted: 10/30/2023] [Indexed: 12/01/2023] Open
Abstract
Background Stress urinary incontinence (SUI) is characterized by the involuntary leakage of urine during activities that increase abdominal pressure. In recent years, a considerable number of studies on SUI surgery have been published. However, there has been a lack of systematic quantification and comprehensive summarization of these studies. Bibliometrics is a discipline that utilizes measurement methods to quantify scientific literature. Thus, this study utilized publications from the Web of Science (WOS) as a data source and conducted a comprehensive analysis and visualization of studies related to SUI surgery in recent years using bibliometric techniques. Methods We conducted a search and retrieved information on 988 studies related to SUI surgery in the WOS Core Collection. The data covered ten years from September 7, 2013, to September 7, 2023. We employed VOSviewer software, CiteSpace software, and Bibliometrix for analysis and visualization. Results Over the ten years, the number of publications exhibited a fluctuating trend, initially decreasing and then increasing. The United States emerged as the leading contributor in terms of both publication volume and quality. The University of Alabama Birmingham ranked as the institution with the highest number of publications, while the International Urogynecology Journal featured the most publications among journals. Conclusions This paper presents a bibliometric analysis of publications related to SUI surgery from 2013 to 2023. The aim is to offer researchers a concise overview of the field and inspire future research directions.
Collapse
Affiliation(s)
| | | | | | - Lian Yang
- Department of Obstetrics and Gynecology, Renmin Hospital of Wuhan University, Wuhan, 430060, Hubei Province, PR China
| | - Hanyue Li
- Department of Obstetrics and Gynecology, Renmin Hospital of Wuhan University, Wuhan, 430060, Hubei Province, PR China
| | - Li Hong
- Department of Obstetrics and Gynecology, Renmin Hospital of Wuhan University, Wuhan, 430060, Hubei Province, PR China
| |
Collapse
|
|
11
|
Dibb B, Woodgate F, Taylor L. When things go wrong: experiences of vaginal mesh complications. Int Urogynecol J 2023; 34:1575-1581. [PMID: 36607398 PMCID: PMC10287809 DOI: 10.1007/s00192-022-05422-z] [Citation(s) in RCA: 7] [Impact Index Per Article: 3.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/23/2022] [Accepted: 11/14/2022] [Indexed: 01/07/2023]
Abstract
INTRODUCTION Previous research has suggested that complications stemming from vaginal mesh can lead to life-changing negative physical consequences including erosion and chronic pain. However, there has been little research on the experiences of women who have had complications. This study was aimed at exploring the individual experiences of women who have had vaginal mesh complications and how this has impacted them. METHODS An explorative qualitative design was followed. Eighteen semi-structured interviews were conducted with women who had experienced complications with vaginal mesh due to stress urinary incontinence and pelvic organ prolapse. The mean age was 52 and the mean time since the mesh was fitted was 8 years (6 had since had it removed and a further 6 had had partial removal), and the mean time since first mesh-related symptom was 10 months. Data were analysed using thematic analysis. RESULTS Four main themes were identified: perceived impact of mesh complications, attitudes of medical professionals, social support and positive growth. Results showed that participant experiences of their mesh complication were psychologically traumatic, including feelings of increased anxiety and fears relating to suicidal thoughts. Intimate relationships were also affected, with reduced sexual functioning and intimacy stemming from mesh complications. Negative experiences with medical professionals included feeling dismissed, a lack of recognition of their symptoms, and anger towards the profession. CONCLUSIONS The impacts of vaginal mesh complications were found to be wide-reaching and life-changing, affecting numerous aspects of participants' lives. Greater awareness in this area is needed to provide further support for women experiencing vaginal mesh complications.
Collapse
Affiliation(s)
- Bridget Dibb
- School of Psychology, University of Surrey, Guildford, Surrey, GU2 7XH, UK.
| | - Fee Woodgate
- School of Psychology, University of Surrey, Guildford, Surrey, GU2 7XH, UK
| | - Lauren Taylor
- School of Psychology, University of Surrey, Guildford, Surrey, GU2 7XH, UK
| |
Collapse
|
|
12
|
Alexandridis V, Lundmark Drca A, Ek M, Westergren Söderberg M, Andrada Hamer M, Teleman P. Retropubic slings are more efficient than transobturator at 10-year follow-up: a Swedish register-based study. Int Urogynecol J 2023:10.1007/s00192-023-05506-4. [PMID: 36995417 DOI: 10.1007/s00192-023-05506-4] [Citation(s) in RCA: 7] [Impact Index Per Article: 3.5] [Reference Citation Analysis] [Abstract] [Key Words] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/16/2022] [Accepted: 02/07/2023] [Indexed: 03/31/2023]
Abstract
INTRODUCTION AND HYPOTHESIS Long-term performance of mid-urethral slings (MUS) and potential differences between the retropubic and the transobturator technique for insertion are scarcely studied. This study aims to evaluate the efficacy and safety 10 years after surgery and compare the two main surgical techniques used. METHODS Women who underwent surgery with a MUS between 2006 and 2010 were identified using the Swedish National Quality Register of Gynecological Surgery and were invited 10 years after the operation to answer questionnaires regarding urinary incontinence and its impact on quality-of-life parameters (UDI-6, IIQ-7) and impression of improvement, as well as questions regarding possible sling-related complications and reoperation. RESULTS The subjective cure rate reported by 2421 participating women was 63.3%. Improvement was reported by 79.2% of the participants. Women in the retropubic group reported higher cure rates, lower urgency urinary incontinence rates and lower UDI-6 scores. No difference was shown between the two methods regarding complications, reoperation due to complications or IIQ-7 scores. Persisting sling-related symptoms were reported by 17.7% of the participants, most commonly urinary retention. Mesh exposure was reported by 2.0%, reoperation because of the tape by 5.6% and repeated operation for incontinence by 6.9%, significantly more in the transobturator group (9.1% vs. 5.6%). Preoperative urinary retention was a strong predictor for impaired efficacy and safety at 10 years. CONCLUSIONS Mid-urethral slings demonstrate good results for the treatment of stress urinary incontinence and tolerable complication profiles in a 10-year perspective. The retropubic approach displays higher efficacy than the transobturator, with no difference regarding safety.
Collapse
Affiliation(s)
- Vasileios Alexandridis
- Department of Clinical Sciences Lund, Lund University, Lund, Sweden.
- Department of Obstetrics and Gynecology, Jan Waldenströms gata 47, 205 02, Malmö, Sweden.
| | - Anna Lundmark Drca
- Department of Clinical Science and Education, Karolinska Institutet, Stockholm, Sweden
| | - Marion Ek
- Department of Clinical Science and Education, Karolinska Institutet, Stockholm, Sweden
| | | | | | - Pia Teleman
- Department of Clinical Sciences Lund, Lund University, Lund, Sweden
| |
Collapse
|
|
13
|
Daykan Y, Klein Z, Eliner O, O'Reilly BA, Yagur Y, Belkin S, Ribak R, Arbib N, Schonman R. Can obesity impact mesh exposure rate after mid-urethral sling operation? Medium term follow-up. Eur J Obstet Gynecol Reprod Biol 2023; 280:98-101. [PMID: 36442380 DOI: 10.1016/j.ejogrb.2022.11.014] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/22/2022] [Revised: 11/10/2022] [Accepted: 11/17/2022] [Indexed: 11/22/2022]
Abstract
OBJECTIVE To study mesh exposure rates among obese (BMI ≥ 30 kg/m2) vs non-obese women after mid-urethral sling (MUS) operation. STUDY DESIGN This retrospective cohort study included all patients who underwent MUS surgery for stress urinary incontinence April 2014-April 2021 in a tertiary-level university hospital. Data from obese and non-obese patients were compared. RESULTS A total of 120 (41 %) obese patients and 172 (59 %) non-obese patients who had mid-urethral sling surgery were compared. Of the cohort, 265 (90.7 %) underwent TVT-obturator, 15 (5.1 %) mini-sling TVT, and 12 (4.1 %) retro-pubic TVT. Diabetes mellitus was significantly more prevalent in the obese group (p =.01), without other demographic differences. Mesh post-operative exposure rate was 5.4 % during the study. The obese group had lower incidence of mesh exposure than the non-obese group (1.6 % vs 8.1 % respectively, p =.018). Mean follow-up was 51 months (range 8-87 months) without significant differences between groups (49.9 ± 21.2 vs 51.5 ± 22.3, p =.548). Pelvic organ prolapse, cystocele, and rectocele stages were significantly higher in non-obese patients. Similar numbers of post-menopausal women were in each group. CONCLUSION This follow-up after MUS surgery showed an association between obesity and lower rate of mesh exposure. Further research is needed to evaluate correlations between estrogen and mesh exposure.
Collapse
Affiliation(s)
- Yair Daykan
- Department of Obstetrics and Gynecology, Meir Medical Center, Kfar Saba, Israel; Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel; Department of Urogynaecology, Cork University Maternity Hospital, Cork, Ireland.
| | - Zvi Klein
- Department of Obstetrics and Gynecology, Meir Medical Center, Kfar Saba, Israel; Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel
| | - Or Eliner
- Department of Obstetrics and Gynecology, Meir Medical Center, Kfar Saba, Israel; Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel
| | - Barry A O'Reilly
- Department of Urogynaecology, Cork University Maternity Hospital, Cork, Ireland
| | - Yael Yagur
- Department of Obstetrics and Gynecology, Meir Medical Center, Kfar Saba, Israel; Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel
| | - Shir Belkin
- Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel
| | - Rachel Ribak
- Department of Obstetrics and Gynecology, HaEmek Medical Center, Afula, Israel. Affiliated to Ruth and Bruce Rappaport Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel
| | - Nissim Arbib
- Department of Obstetrics and Gynecology, Meir Medical Center, Kfar Saba, Israel; Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel
| | - Ron Schonman
- Department of Obstetrics and Gynecology, Meir Medical Center, Kfar Saba, Israel; Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel
| |
Collapse
|
|
14
|
Cartier S, Cerantola GM, Leung AA, Brennand E. The impact of surgeon operative volume on risk of reoperation within 5 years of mid-urethral sling: a systematic review. Int Urogynecol J 2022; 34:981-992. [PMID: 36538044 DOI: 10.1007/s00192-022-05426-9] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/18/2022] [Accepted: 11/30/2022] [Indexed: 12/24/2022]
Abstract
INTRODUCTION AND HYPOTHESIS Undesired outcomes after mid-urethral sling (MUS), such as mesh exposure or surgical failure, can necessitate further procedures. The objective of this review is to evaluate the association between surgeon operative volume and the risk of reoperation after MUS. METHODS Eligible studies were selected through an electronic literature search from database and references of the studies included. Databases were searched for original studies reporting on the MUS procedure, reoperation, and operative volume. Random effects models were used to estimate the pooled OR of reoperation according to surgeon volume. Outcomes were divided into two categories: mesh removal and/or revision and subsequent surgery for treatment of SUI. RESULTS A total of 2,304 abstracts were screened, and 51 studies were assessed through full-text reading. Seven studies were included in the systematic review. High-volume and low-volume surgeons were defined differently in various studies. The odds ratio of the mesh removal/revision procedure was 1.26 (95%CI 1.03-1.53) among those who received their surgery from a low-volume surgeon compared with those who received their surgery from a high-volume surgeon as defined by the studies. The odds ratio of repeated incontinence procedures was 1.18 (95% CI 1.01-1.37). CONCLUSIONS The odds of a repeat incontinence procedure appear higher if the surgery is performed by a low-volume surgeon, although these results need to be interpreted with caution as the definition of low-volume vs high-volume surgeon varied between studies. As such, operative volume should be included in surgical reporting, and future research should utilize surgical volume as either a continuous exposure or a standardized value of low- vs high-volume MUS surgeons.
Collapse
Affiliation(s)
- Sophie Cartier
- Département d'obstétrique-gynécologie, Université de Montréal, Montréal, Québec, Canada.
| | - Gina-Marie Cerantola
- Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada
| | - Alexander A Leung
- Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada
- Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada
| | - Erin Brennand
- Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada
- Department of Obstetrics & Gynecology, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada
| |
Collapse
|
|
15
|
Ros C, Escura S, Anglès-Acedo S, Bataller E, Amat L, Sánchez E, Espuña-Pons M, Carmona F. Readjustable Sling in Women With Stress Urinary Incontinence and Hypomobile Urethra: Understanding the Mechanisms of Closure by Transperineal Ultrasound. JOURNAL OF ULTRASOUND IN MEDICINE : OFFICIAL JOURNAL OF THE AMERICAN INSTITUTE OF ULTRASOUND IN MEDICINE 2022; 41:3069-3078. [PMID: 36044020 DOI: 10.1002/jum.16076] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 03/13/2022] [Revised: 07/07/2022] [Accepted: 07/17/2022] [Indexed: 06/15/2023]
Abstract
OBJECTIVES To assess the postsurgical sonographic parameters of a readjustable sling (RAS) according to urinary incontinence (UI) symptoms after surgery and compare this RAS sonographic pattern with mid-urethral slings (MUS). METHODS Observational, prospective multicenter study, including women undergoing stress urinary incontinence (SUI) surgery with RAS (Remeex®). The primary outcome was the association between UI symptoms and sonographic parameters measured by two-dimensional transperineal and high-frequency endovaginal ultrasound. We measured static parameters (bladder neck funneling, RAS position, symmetry, distance to the urethral lumen), and the movement of the sling on Valsalva. UI symptoms were measured with the postsurgical Incontinence Questionnaire-Short Form (ICIQ-UI-SF) questionnaire. We created two control groups including patients with transobturator-MUS (TOT-MUS) and retropubic-MUS (RT-MUS) to compare postsurgical sonographic parameters of RAS with MUS. RESULTS Among the 55 women with RAS included, the postoperative ICIQ-UI-SF scores were significantly higher in patients with bladder neck funneling (15.0 (3.9) vs 10.6 (6.7); P = .020) and in those with discordant movement of RAS on Valsalva (14.6 (5.7) vs 10.3 (6.7); P = .045). Compared with the 109 women with TOT-MUS and the 55 with RT-MUS, RAS was more often located in the proximal urethra and farther from the urethral lumen. CONCLUSIONS Postsurgical pelvic floor ultrasound demonstrated that in women with complex SUI and hypomobile urethra who underwent RAS (Remeex®) surgery, the presence of bladder neck funneling and discordant movement on Valsalva correlate with the persistence of UI symptoms. In these women, RAS is more often located in the proximal urethra and farther from the urethral lumen at rest in comparison with MUS.
Collapse
Affiliation(s)
- Cristina Ros
- Pelvic Floor Unit, ICGON, Hospital Clínic de Barcelona, University of Barcelona, Barcelona, Spain
| | - Sílvia Escura
- Pelvic Floor Unit, ICGON, Hospital Clínic de Barcelona, University of Barcelona, Barcelona, Spain
| | - Sònia Anglès-Acedo
- Pelvic Floor Unit, ICGON, Hospital Clínic de Barcelona, University of Barcelona, Barcelona, Spain
| | - Eduardo Bataller
- Pelvic Floor Unit, ICGON, Hospital Clínic de Barcelona, University of Barcelona, Barcelona, Spain
| | - Lluís Amat
- Pelvic Floor Unit, Hospital Sant Joan de Déu de Barcelona, University of Barcelona, Barcelona, Spain
| | - Emília Sánchez
- Pelvic Floor Unit, ICGON, Hospital Clínic de Barcelona, University of Barcelona, Barcelona, Spain
| | - Montserrat Espuña-Pons
- Pelvic Floor Unit, ICGON, Hospital Clínic de Barcelona, University of Barcelona, Barcelona, Spain
| | - Francisco Carmona
- Pelvic Floor Unit, ICGON, Hospital Clínic de Barcelona, University of Barcelona, Barcelona, Spain
| |
Collapse
|
|
16
|
Baird CE, Chughtai B, Bradley CS, Kobashi K, Jung M, Sedrakyan A, Andrews S, Ferriter A, Cornelison T, Marinac-Dabic D. Development of a coordinated registry network for pelvic organ prolapse technologies. BMJ SURGERY, INTERVENTIONS, & HEALTH TECHNOLOGIES 2022; 4:e000076. [PMID: 36393893 PMCID: PMC9660621 DOI: 10.1136/bmjsit-2020-000076] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/08/2021] [Accepted: 05/13/2022] [Indexed: 11/16/2022] Open
Abstract
Objectives The accumulation of data through a prospective, multicenter Coordinated Registry Network (CRN) could be a robust and cost-effective way to gather real-world evidence on the performance of pelvic organ prolapse (POP) technologies for device-based and intervention-based studies. To develop the CRN, a group of POP experts consisting of representatives from professional societies, the Food and Drug Administration, academia, industry, and the patient community, was convened to discuss the role and feasibility of the CRN and to identify the core data elements important to assess POP technologies. Design A Delphi method approach was employed to achieve consensus on a core minimum dataset for the CRN. A series of surveys were sent to the panel and answered by each expert anonymously and individually. Results from the surveys were collected, collated, and analyzed by the study design team from Weill Cornell Medicine. Questions for the next round were based on the analysis process and discussed with group members via conference call. This process was repeated twice over a 6-month time period during which consensus was achieved. Results Twenty-one experts participated in the effort and proposed 120 data elements. Participation rates in the first and second round of the Delphi survey were 95.2% and 71.4%, respectively. The working group reached final consensus among responders on 90 data elements capturing relevant general medical and surgical history, procedure and discharge, short-term and long-term follow-up, device factors, and surgery and surgeon factors. Conclusions The CRN successfully developed a set of core data elements to support the study of POP technologies through convening an expert panel on POP technologies and using the Delphi method. These standardized data elements have the potential to influence patient and provider decisions about treatments and include important outcomes related to efficacy and safety.
Collapse
Affiliation(s)
- Courtney E Baird
- Health Services, Policy, and Practice, Brown University School of Public Health, Providence, Rhode Island, USA
- Population Health Sciences, Weill Cornell Medicine, New York, New York, USA
| | - Bilal Chughtai
- Department of Urology, Weill Cornell Medicine, New York, New York, USA
| | - Catherine S Bradley
- Department of Obstetrics and Gynecology, The University of Iowa Roy J and Lucille A Carver College of Medicine, Iowa City, Iowa, USA
| | - Kathleen Kobashi
- Department of Urology, Houston Methodist Hospital, Houston, Texas, USA
| | - Mary Jung
- Center for Devices and Radiological Health (CDRH), US Food and Drug Administration, Silver Spring, Maryland, USA
| | - Art Sedrakyan
- Population Health Sciences, Weill Cornell Medicine, New York, New York, USA
| | - Sharon Andrews
- Center for Devices and Radiological Health (CDRH), US Food and Drug Administration, Silver Spring, Maryland, USA
| | - Ann Ferriter
- Center for Devices and Radiological Health (CDRH), US Food and Drug Administration, Silver Spring, Maryland, USA
| | - Terri Cornelison
- Center for Devices and Radiological Health (CDRH), US Food and Drug Administration, Silver Spring, Maryland, USA
| | - Danica Marinac-Dabic
- Center for Devices and Radiological Health (CDRH), US Food and Drug Administration, Silver Spring, Maryland, USA
| |
Collapse
|
|
17
|
Toia B, Unterberg S, Sihra N, Pakzad M, Hamid R, Ockrim JL, Greenwell TJ. Functional outcomes of vaginal surgery for urethral extrusion of mid-urethral tape in women. Int Urogynecol J 2022; 33:2251-2256. [PMID: 33822257 DOI: 10.1007/s00192-021-04774-2] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/16/2020] [Accepted: 03/21/2021] [Indexed: 11/29/2022]
Abstract
INTRODUCTION AND HYPOTHESIS We aim to determine the presentation of and immediate and longer-term outcomes of vaginal surgical excision of urethral extrusion of mid-urethral tape (MUT). METHODS We performed a retrospective analysis of all patients with urethral extrusion of MUT having vaginal surgical excision between 2007 and 2018. The MUT was removed either partially (via vaginal approach) or completely (via combined vaginal and laparoscopic approach). Functional outcomes and any re-interventions are described. RESULTS Thirty-four patients of median age 53 (range 34-82) years were identified. Preoperative symptomatic recurrent/persistent urinary incontinence was present in 29/34(85%) with 24/34(71%) women having recurrent/persistent stress urinary incontinence (SUI) or stress predominant mixed urinary incontinence (s-MUI) on urodynamics. Vaginal surgical excision was performed alone in 33/34(97%) women and in combination with laparoscopic removal of abdominopelvic MUT in 1/34(3%) woman. In the longer term vaginal/urethral pain resolved or improved in all 15/15(100%) patients presenting with this complaint whilst patient reported poor flow resolved in 8/9 (89%) women. Twenty-eight of 34 women (82%) had persistent/recurrent SUI or s-MUI following MUT excision. Twenty-four of 34 women (71%) had further SUI surgery with cure or improvement of SUI in 20/24 (83%) patients. CONCLUSIONS The outcome of vaginal surgical excision of the MUT was cure or improvement of pain in 100% and resolution of poor flow in 89% women. Recurrent/persistent SUI or s-MUI was present in 82% following removal as compared to 71% women prior to removal. Of the 71% of women electing to have further surgery for recurrent/persistent SUI/s-MUI, 83% were dry or improved afterwards.
Collapse
Affiliation(s)
- Bogdan Toia
- Department of Urology, University College London Hospital, Westmoreland Street, London, UK.
| | - Stephen Unterberg
- Department of Urology, University College London Hospital, Westmoreland Street, London, UK
| | - Neha Sihra
- Department of Urology, University College London Hospital, Westmoreland Street, London, UK
| | - Mahreen Pakzad
- Department of Urology, University College London Hospital, Westmoreland Street, London, UK
| | - Rizwan Hamid
- Department of Urology, University College London Hospital, Westmoreland Street, London, UK
| | - Jeremy L Ockrim
- Department of Urology, University College London Hospital, Westmoreland Street, London, UK
| | - Tamsin J Greenwell
- Department of Urology, University College London Hospital, Westmoreland Street, London, UK
| |
Collapse
|
|
18
|
Chaudhry Z, Kreydin E, Oliver J, Raz S. Predictors of prolonged hospitalization and perioperative complications following mid-urethral sling mesh removal. World J Urol 2022; 40:1793-1797. [PMID: 35534576 DOI: 10.1007/s00345-022-04021-3] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/14/2021] [Accepted: 04/19/2022] [Indexed: 11/29/2022] Open
Abstract
PURPOSE To assess preoperative and perioperative characteristics associated with increased length of stay and major complications after mid-urethral sling mesh removal. METHODS We performed an IRB-approved retrospective analysis of patients who underwent mid-urethral sling mesh removal. Demographic data and baseline surgical characteristics were collected. Operative reports and hospital/clinic notes were reviewed for complications which were categorized using the Clavien-Dindo Classification scheme. Length of stay was deemed abnormal if greater than 1 day. Complications were assessed using multivariate regression analysis. RESULTS A total of 468 patients were identified as having undergone mid-urethral sling mesh removal. Mean age was 56 (± 11.1). 431 patients had either retropubic or transobturator slings. 241 patients underwent retropubic or groin exploration as a part of their mesh removal. A prolonged length of stay was noted in 73 patients (15.6%) and 13 patients (2.8%) experienced a Clavien Grade 3 complication. Pre-operative narcotic/benzodiazepine use, concomitant surgical procedure, bladder injury, increased ASA class, and major complications had an increased odds of a prolonged length of stay. Patients who experienced a bladder injury, groin/suprapubic incision, and estimated blood loss of over 400 mL had an increased odds of Clavien Grade 3 complications. CONCLUSIONS Patient characteristics and perioperative factors are associated with increased length of stay and major complications after mid-urethral sling mesh removal.
Collapse
Affiliation(s)
| | - Evgeniy Kreydin
- Catherine and Joseph Aresty Department of Urology, Keck School of Medicine of USC, Los Angeles, CA, USA
| | - Janine Oliver
- Division of Urology, Department of Surgery, University of Colorado School of Medicine, Aurora, CO, USA
| | - Shlomo Raz
- Division of Pelvic Medicine and Reconstructive Surgery, Department of Urology, UCLA David Geffen School of Medicine, Los Angeles, CA, USA
| |
Collapse
|
|
19
|
Manufacturer and User Facility Device Experience Reporting of Events Related to Transvaginal Mesh: Understanding the Data. Female Pelvic Med Reconstr Surg 2022; 28:332-335. [PMID: 35421039 DOI: 10.1097/spv.0000000000001177] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/26/2022]
Abstract
OBJECTIVE The aim of this study was to examine potential bias in reports to the Manufacturer and User Facility Device Experience (MAUDE) database involving vaginal mesh by identifying the party submitting the report, the nature of the complaints, and whether the reports were edited. METHODS All reports submitted to the MAUDE database involving synthetic transvaginal mesh from January 2000 through December 2017 (40,266 safety reports) were identified. A random 2% sample (900) of these reports was reviewed in depth to determine the specific relevant details, including reporter type (patient, manufacturer, lawyer) and details of the complaint/injury. RESULTS Of the 40,226 reports to MAUDE identified, 28,473 (70.7%) were sling reports, and 11,793 (29.3%) described mesh products augmenting pelvic organ prolapse repair. Of the 900 reports reviewed in depth, 46%, 41%, 10%, and 2% of entries were reported by the manufacturer, attorney, health care provider, and patients, respectively. In the 4 years after submission, 18.6% of reports were modified at least once. CONCLUSIONS The MAUDE database allows physicians, manufacturers, and patients to immediately report adverse events experienced due to medical devices. While this database is an important means to identify potential danger to patients, any individual can file a report and, thus, it should not be the sole source of evidence to consider when assessing device safety. Further, the MAUDE database provides no information into the total number of cases performed without complication.
Collapse
|
|
20
|
Ablatt S, Wang X, Sahil S, Cheng AL, Shepherd JP, Sutkin G. Reoperation Rates of Stress Incontinence Surgery in Rural versus Urban Hospitals. AJOG GLOBAL REPORTS 2022; 2:100059. [PMID: 36276800 PMCID: PMC9563384 DOI: 10.1016/j.xagr.2022.100059] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Grants] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/30/2022] Open
Abstract
BACKGROUND OBJECTIVE STUDY DESIGN RESULTS CONCLUSION
Collapse
|
|
21
|
Ros C, Escura S, Anglès-Acedo S, Larroya M, Bataller E, Amat L, Sánchez E, Espuña-Pons M, Carmona F. Mid-term results of the Remeex® readjustable sling for female complex stress urinary incontinence and sonographic hypomobile urethra. Int Urogynecol J 2022; 33:903-910. [PMID: 34505924 DOI: 10.1007/s00192-021-04972-y] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/13/2021] [Accepted: 08/03/2021] [Indexed: 01/02/2023]
Abstract
INTRODUCTION AND HYPOTHESIS We aimed to evaluate the results of a readjustable sling (Remeex® system) among a selected group of women with complex stress urinary incontinence (SUI) with sonographic hypomobile urethra and assessing failure-related risk factors. METHODS Observational, longitudinal, prospective cohort study, including patients who underwent surgery with the Remeex® system. The primary outcome was a binary outcome in change of one level or more of the severity of urinary incontinence symptoms according to the intervals of the Incontinence Questionnaire-Short Form (ICIQ-UI-SF) score (mild, moderate, severe and very severe). Secondary outcomes were postsurgical complications, absolute ICIQ-UI-SF, 24-h pad weight test (24-h PT), urodynamic SUI and Patient Global Impression of Improvement (PGI-I) score to evaluate subjective success. RESULTS Among 120 women included, after surgery we found a 70% subjective success rate, a 76.7% decrease of urinary incontinence severity and a mean reduction of the 24-h PT of 109.6 ± 291.4 g. Women with post-surgical decreased severity of incontinence had lower mean body mass index (BMI) and 24-h PT than those without incontinence severity changes with statistically significant differences (p = 0.028 and p = 0.027, respectively). A logistic regression model demonstrated that a 1-point increase of BMI increased the risk of persistence of incontinence severity after surgery by 19% (OR = 1.19; 95% CI: 1.01-1.41; p = 0.040), and an increase of 10 g in the pre-surgical 24-h PT represented a 3% rise of the aforementioned risk (OR = 1.03; 95% CI: 1.01-1.06; p = 0.034). CONCLUSIONS In patients with complex SUI and sonographic hypomobile urethra, use of a readjustable sling (Remeex® system) led to improvement of SUI. Patients with a greater BMI and pre-surgical 24-h PT showed worse results after surgery.
Collapse
Affiliation(s)
- Cristina Ros
- Pelvic Floor Unit, ICGON, Hospital Clínic de Barcelona, University of Barcelona, Villarroel 170, 08036, Barcelona, Spain.
| | - Sílvia Escura
- Pelvic Floor Unit, ICGON, Hospital Clínic de Barcelona, University of Barcelona, Villarroel 170, 08036, Barcelona, Spain
| | - Sònia Anglès-Acedo
- Pelvic Floor Unit, ICGON, Hospital Clínic de Barcelona, University of Barcelona, Villarroel 170, 08036, Barcelona, Spain
| | - Marta Larroya
- Pelvic Floor Unit, ICGON, Hospital Clínic de Barcelona, University of Barcelona, Villarroel 170, 08036, Barcelona, Spain
| | - Eduardo Bataller
- Pelvic Floor Unit, ICGON, Hospital Clínic de Barcelona, University of Barcelona, Villarroel 170, 08036, Barcelona, Spain
| | - Lluís Amat
- Pelvic Floor Unit, Hospital Sant Joan de Déu de Barcelona, University of Barcelona, Barcelona, Spain
| | - Emília Sánchez
- Pelvic Floor Unit, ICGON, Hospital Clínic de Barcelona, University of Barcelona, Villarroel 170, 08036, Barcelona, Spain
| | - Montserrat Espuña-Pons
- Pelvic Floor Unit, ICGON, Hospital Clínic de Barcelona, University of Barcelona, Villarroel 170, 08036, Barcelona, Spain
| | - Francisco Carmona
- Pelvic Floor Unit, ICGON, Hospital Clínic de Barcelona, University of Barcelona, Villarroel 170, 08036, Barcelona, Spain
| |
Collapse
|
|
22
|
Abhari RE, Izett-Kay ML, Morris HL, Cartwright R, Snelling SJB. Host-biomaterial interactions in mesh complications after pelvic floor reconstructive surgery. Nat Rev Urol 2021; 18:725-738. [PMID: 34545239 DOI: 10.1038/s41585-021-00511-y] [Citation(s) in RCA: 10] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 07/29/2021] [Indexed: 02/08/2023]
Abstract
Polypropylene (PPL) mesh is widely used in pelvic floor reconstructive surgery for prolapse and stress urinary incontinence. However, some women, particularly those treated using transvaginal PPL mesh placement for prolapse, experience intractable pain and mesh exposure or extrusion. Explanted tissue from patients with complications following transvaginal implantation of mesh is typified by a dense fibrous capsule with an immune cell-rich infiltrate, suggesting that the host immune response has a role in transvaginal PPL mesh complications through the separate contributions of the host (patient), the biological niche within which the material is implanted and biomaterial properties of the mesh. This immune response might be strongly influenced by both the baseline inflammatory status of the patient, surgical technique and experience, and the unique hormonal, immune and microbial tissue niche of the vagina. Mesh porosity, surface area and stiffness also might have an effect on the immune and tissue response to transvaginal mesh placement. Thus, a regulatory pathway is needed for mesh development that recognizes the roles of host and biological factors in driving the immune response to mesh, as well as mandatory mesh registries and the longitudinal surveillance of patients.
Collapse
Affiliation(s)
- Roxanna E Abhari
- Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford, UK.
| | - Matthew L Izett-Kay
- Department of Urogynaecology, Oxford University Hospitals NHS Trust, Oxford, UK.,Nuffield Department of Women's & Reproductive Health, University of Oxford, Oxford, UK
| | - Hayley L Morris
- Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford, UK
| | - Rufus Cartwright
- Department of Urogynaecology, London North West Hospitals NHS Trust, London, UK.,Department of Epidemiology & Biostatistics, Imperial College London, London, UK
| | - Sarah J B Snelling
- Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford, UK.,NIHR Oxford Biomedical Research Centre, Oxford, UK
| |
Collapse
|
|
23
|
Nager CW. Long-term data support slings as the best surgical procedures for stress urinary incontinence. Am J Obstet Gynecol 2021; 225:591-592. [PMID: 34844701 DOI: 10.1016/j.ajog.2021.09.022] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/20/2021] [Accepted: 09/22/2021] [Indexed: 10/19/2022]
|
|
24
|
Improvement in dyspareunia after vaginal mesh removal measured by a validated questionnaire. Int Urogynecol J 2021; 32:2937-2946. [PMID: 34351464 DOI: 10.1007/s00192-021-04923-7] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/16/2021] [Accepted: 06/12/2021] [Indexed: 12/14/2022]
Abstract
INTRODUCTION AND HYPOTHESIS The objective was to examine the effect of the surgical removal of vaginally placed prolapse and incontinence mesh on sexual function. We hypothesize that patients with painful complications of mesh will experience improvement in dyspareunia and sexual function after mesh removal. METHODS The eligible cohort consisted of 133 women who presented with a new onset of pain attributed to mesh-augmented incontinence or prolapse surgery and who elected to undergo mesh removal between 1 August 2012 and 1 July 2013. Sexual function symptoms were assessed before and after mesh removal surgery using the Pelvic Organ Prolapse and Urinary Incontinence Sexual Function Questionnaire short form (PISQ-12). Multivariate analysis was performed to identify predictors of improvement in dyspareunia. RESULTS Ninety-four patients undergoing mesh removal completed a pre-operative questionnaire, 63 of whom also completed a post-operative questionnaire. After mesh removal, there was a nearly 50% reduction in the proportion of women reporting always experiencing post-operative pain with intercourse among those experiencing pre-operative pain. There was a statistically significant quantitative improvement in pain with intercourse after mesh removal based on mean change score of PISQ-12 question 5 "How often do you experience pain with intercourse?". In multivariate analysis, only history of vaginal delivery was associated with symptom improvement. CONCLUSION Removal of transvaginal prolapse mesh is associated with improvement in self-reported dyspareunia based on a standardized question on a validated instrument in a small cohort of women. Although larger studies are needed to confirm the relationship between mesh-augmented surgeries and post-procedural dyspareunia, these data suggest that consideration of mesh removal is a reasonable step for patients with painful intercourse attributed to mesh-augmented prolapse and incontinence surgeries.
Collapse
|
|
25
|
Long-Term Outcomes After Midurethral Mesh Sling Surgery for Stress Urinary Incontinence. Female Pelvic Med Reconstr Surg 2021; 28:188-193. [PMID: 34608036 DOI: 10.1097/spv.0000000000001094] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/26/2022]
Abstract
OBJECTIVES Although midurethral mesh slings are the criterion standard surgical treatment for stress urinary incontinence (SUI), limited data exist regarding long-term outcomes. Thus, our objectives were to evaluate the long-term risk of sling revision and the risk of repeat SUI surgery up to 15 years after the initial sling procedure and to identify predictors of these outcomes. METHODS Using a population-based cohort of commercially insured individuals in the United States, we identified women aged 18 years or older who underwent a sling procedure between 2001 and 2018. For sling revision, we evaluated indications (mesh exposure or urinary retention). We estimated the cumulative risks of sling revision and repeat SUI surgery annually using Kaplan-Meier survival curves and evaluated predictors using Cox proportional hazards models. RESULTS We identified 334,601 mesh sling surgical procedures. For sling revision, the 10-year and 15-year risks were 6.9% (95% confidence interval [CI], 6.7-7.0) and 7.9% (95% CI, 7.5-8.3), with 48.7% of sling revisions associated with mesh exposure. The 10-year and 15-year risks of repeat SUI surgery were 14.5% (95% CI, 14.2-14.8) and 17.9% (95% CI, 17.3-18.6). Women aged 18-29 years had an elevated risk for both sling revision (hazard ratio, 1.20; 95% CI, 1.15-1.25) and repeat SUI surgery (hazard ratio, 1.30; 95% CI, 1.25-1.37) compared with women 70 years and older. CONCLUSIONS In our study population, the 15-year risk of sling revision was 7.9%, with nearly half of revisions due to mesh exposure. These findings provide critical long-term data to support informed decisions for women and health care providers considering midurethral mesh slings.
Collapse
|
|
26
|
Rodrigues P, Raz S. The Burden of Reoperations and Timeline of Problems in 1,530 Cases of Mesh-Related Complications. Urol Int 2021; 106:235-242. [PMID: 33887745 DOI: 10.1159/000514389] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/15/2020] [Accepted: 01/07/2021] [Indexed: 11/19/2022]
Abstract
BACKGROUND Mesh-related complications resulting from pelvic organ prolapse (POP) reconstruction operations may be a devastating experience leading to multiple and complex interventions. OBJECTIVES The aim of the study was to describe the experience and time frame of management of mesh-related complications in women treated for POP or stress urinary incontinence in a tertiary center. METHODS 1,530 cases of mesh-related complications were accessed regarding their clinical presentation, number of surgeries, and timeline of surgical treatments to treat multiple clinical complaints until the ultimate operation where all the meshes were removed in a single tertiary center. RESULTS The studied population revealed to be a highly referred one with only 10.2% of the cases implanted at our center. Clinical presentation varied widely with 48.7% referring pain as the chief complaint, while 31.3% complained of voiding dysfunctions, 2.5% reported genital prolapses, 2.2% complained of vaginal problems, and 1.2% noted intestinal problems as the main clinical complaint. Only 4.8% of the cases presented mesh erosion at examination; 57.8% of the cases required more than 1 operation to address the mesh-related problems. Sixty-eight cases had more than 10 operations up to complete removal. Three clusters of patients could be identified: (i)-those from whom the mesh was promptly removed after clinical problems emerged, (ii) those with slowly evolving problems, and (iii) those with escalating problems despite treatment attempts. CONCLUSIONS Mesh-related complications after pelvic floor reconstruction are an evolving disease with diverse clinical presentation. The identified time-related problems and the multiple failed attempts to treat their complications warrant attention with continuous monitoring of these patients and aggressive removal of the mesh if the clinical complaint cannot be swiftly managed.
Collapse
Affiliation(s)
- Paulo Rodrigues
- Division of Pelvic Medicine and Reconstructive Surgery, University of California Los Angeles-UCLA, São Paulo, Brazil
| | - Shlomo Raz
- Division of Pelvic Medicine and Reconstructive Surgery, University of California Los Angeles-UCLA, São Paulo, Brazil
| |
Collapse
|
|
27
|
Baxter H, Carter E, Marris K, Nugent R, Weaver E. Effect of surgeon volume on long-term quality of life outcomes following tension-free vaginal tape surgery. Int Urogynecol J 2021; 33:2099-2106. [PMID: 33760990 DOI: 10.1007/s00192-021-04714-0] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/30/2020] [Accepted: 01/31/2021] [Indexed: 10/21/2022]
Abstract
INTRODUCTION AND HYPOTHESIS The role of the general obstetrician/gynaecologist completing routine urogynaecology procedures is controversial, and some research has suggested that these patients should be referred to high-volume subspecialists. In response to recent public and regulatory scrutiny of vaginal mesh procedures, credentialling guidelines have been released in Australia requiring surgeons to demonstrate a minimum caseload prior to performing tension-free vaginal tape (TVT) surgery for incontinence. Hence, a retrospective cohort study was conducted to evaluate the long-term quality of life outcomes of TVT procedures for high- and low-volume surgeons. METHODS One hundred seventy patients who had undergone TVT surgery between 1 May 2011 and 1 May 2016 in the Sunshine Coast health district were invited to complete the UDI-6 (Urinary Distress Inventory) and IIQ-7 (Incontinence Impact Questionnaire) surveys. Perioperative information was accessed from available health records. Mean UDI-6 and IIQ-7 scores were compared for high- and low-volume groups, and the groups were assessed for confounding factors. RESULTS Of the 170 patients eligible, 83 completed the surveys (47.2%). No differences in UDI-6 or IIQ-7 scores were found between high- and low-volume surgeons (p > 0.05). High-volume surgeons completed more concomitant procedures amongst survey respondents (p < 0.05), though this was not reproduced when considering all 170 patients eligible for the study. There were no significant differences in age, ASA (American Society of Anaesthesiologists) score or complication rate amongst survey respondents. CONCLUSIONS Amongst the patients surveyed, high- and low-volume surgeons had similar long-term quality of life outcomes for TVT surgery, without any significant difference in complication rate.
Collapse
Affiliation(s)
- Harold Baxter
- Department of Obstetrics and Gynaecology, Sunshine Coast Hospital and Health Service, Birtinya, Queensland, Australia.
| | - Edward Carter
- Department of Obstetrics and Gynaecology, Sunshine Coast Hospital and Health Service, Birtinya, Queensland, Australia
| | - Kelsi Marris
- School of Public Health and Community Medicine, University of New South Wales, Sydney, New South Wales, Australia
| | - Rachael Nugent
- Department of Obstetrics and Gynaecology, Sunshine Coast Hospital and Health Service, Birtinya, Queensland, Australia
| | - Edward Weaver
- Department of Obstetrics and Gynaecology, Sunshine Coast Hospital and Health Service, Birtinya, Queensland, Australia
| |
Collapse
|
|
28
|
Letter: Canadian Society of Pelvic Medicine Response to the Collège des Médecins du Québec Rapport d'Enquête. JOURNAL OF OBSTETRICS AND GYNAECOLOGY CANADA 2021; 43:298-299. [PMID: 33640099 DOI: 10.1016/j.jogc.2020.10.004] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/11/2020] [Accepted: 10/07/2020] [Indexed: 11/22/2022]
|
|
29
|
Abstract
OBJECTIVE To evaluate the cost-effectiveness of surgical treatment pathways for apical prolapse. STUDY DESIGN We constructed a stochastic Markov model to assess the cost-effectiveness of vaginal apical suspension, laparoscopic sacrocolpopexy, and robotic sacrocolpopexy. We modeled over 5 and 10 years, with 9 pathways accounting for up to 2 separate surgical repairs, recurrence of symptomatic apical prolapse, reoperation, and complications, including mesh excision. We calculated costs from the health care system's perspective. RESULTS Over 5 years, compared with expectant management, all surgical treatment pathways cost less than the willingness-to-pay threshold of US $50,000 per quality adjusted life-years. However, among surgical treatments, all but 2 pathways were dominated. Of the remaining 2, laparoscopic sacrocolpopexy followed by vaginal repair for apical recurrence was not cost-effective compared with the vaginal-only approach (incremental cost-effectiveness ratio [ICER], >$500,000). Over 10 years, all but the same 2 pathways were dominated. However, starting with the laparoscopic approach in this case was more cost-effective with an ICER of US $6,176. If the laparoscopic approach was not available, starting with the robotic approach similarly became more cost-effective at 10 years (ICER, US $35,479). CONCLUSIONS All minimally invasive surgical approaches for apical prolapse repair are cost-effective when compared with expectant management. Among surgical treatments, the vaginal-only approach is the only cost-effective option over 5 years. However, over a longer period, starting with a laparoscopic (or robotic) approach becomes cost-effective. These results help inform discussions regarding the surgical approach for prolapse.
Collapse
|
|
30
|
Mathieson R, Kippen R, Manning T, Brennan J. Stress urinary incontinence in the mesh complication era: current Australian trends. BJU Int 2020; 128:95-102. [PMID: 33226698 DOI: 10.1111/bju.15302] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/22/2022]
Abstract
OBJECTIVES To examine available data relating to the surgical management of stress urinary incontinence (SUI) in Australia before, during and after a well-publicized Senate Inquiry into transvaginal mesh use and to consider outcomes in the context of global guideline changes. PATIENTS AND METHODS The annual number of surgical procedures for the management of SUI by procedure type and age group for the years 2008/2009-2017/2018 was obtained from the Australian Government Department of Human Services database using Medicare Benefits Schedule item numbers. The data extracted were limited to women aged 25 years and older. These data were used to calculate age-specific and age-standardized rates, so as to accurately analyse trends in the usage of different procedures. Hospital Episode Statistics for mid-urethral sling (MUS) insertions were obtained for England's National Health Service from the Health and Social Care Information Centre for the years 2008/2009-2016/2017. These data were also used to calculate annual age-standardized rates for comparison purposes. RESULTS Rates declined for most SUI procedures over time (MUS, colposuspension, fascial slings) except for urethral bulking agents. The absolute number of MUSs implanted in 2008/2009 was 5729, which decreased to 3127 in the 2017/2018 financial year. Over the decade, the annual rate for MUS implantation per 100 000 population halved from 78 to 36. Over this same period, the rate of usage of bulking agents doubled, although represented a low volume of procedures (overall numbers increased from 304 to 698, representing an increase from four to eight procedures per 100 000 population). The age-specific peak rate for MUS and Burch colposuspension changed over the decade from 55-64 years to 65-74 years, suggesting that women are deferring surgical treatment until later in life. Over the last decade, the total number of surgical procedures performed in Australia to treat SUI has decreased markedly from 6812 to 4279. This represents a decrease in the annual rate per 100 000 population from 93 to 49. CONCLUSIONS There are clear changes evident for SUI management in the past decade in Australia, including an overall decline in operative numbers, which correlate with international advisory notifications and local investigations. The results of the Australian Senate inquiry, including removal of single-incision mini-slings, greater availability of patient resources, and greater regulation of SUI procedures, will probably have ongoing effects. Surgeons need to ensure that sufficient training and patient education continue in order to maintain appropriate access to treatment of SUI in the future.
Collapse
Affiliation(s)
| | - Rebecca Kippen
- School of Rural Health, Monash University, Bendigo, Vic., Australia
| | | | - Janelle Brennan
- Bendigo Health, Bendigo, Vic., Australia.,School of Rural Health, Monash University, Bendigo, Vic., Australia.,St Vincent's Hospital Melbourne, Fitzroy, Vic., Australia
| |
Collapse
|
|
31
|
Rates of Sling Procedures and Revisions-A National Surgical Quality Improvement Program Database Study. Female Pelvic Med Reconstr Surg 2020; 27:e559-e562. [PMID: 33315624 DOI: 10.1097/spv.0000000000000995] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/25/2022]
Abstract
OBJECTIVE The aim of this study was to describe trends in sling procedures and revisions, including fascial slings and midurethral slings (MUS) using a large, national database with respect to the 2011 U.S. Food and Drug Administration (FDA) mesh-related safety communication. METHODS This was a cross-sectional cohort study using data from the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) database from 2010 to 2018, evaluating the prevalence of sling revision and fascial slings and their trends over time. Patients who underwent MUS, fascial slings, and sling revisions were identified by Current Procedural Terminology codes. Sling revisions and fascial slings were evaluated as a proportion of the total number of MUS performed per year. Three distinct periods were evaluated in relation to the 2011 FDA communication: 2010 to 2012, 2012 to 2015, and 2015 to 2018. Observed trends were assessed with Pearson correlation coefficients with a P value less than 0.05 considered significant. RESULTS During the study period, 32,657 slings were captured: 32,389 MUS and 268 fascial slings. The rate of sling revisions was low (0.4% in 2010 to 1.2% in 2015). Between 2012 and 2015, the rate of sling revision increased significantly (R = 1, P = 0.002); following 2015, the rate of sling revisions decreased significantly over time (R = -0.96, P = 0.04). The rate of fascial slings between 2012 and 2015 increased significantly (R = 0.95, P = 0.047); however, the rate plateaued starting in 2015 (R = -0.49, -P = 0.51). CONCLUSIONS Our data suggest that MUS remain the preferred procedure for treatment of stress urinary incontinence despite the recent FDA communications with MUS representing 99% of sling procedures during the study period.
Collapse
|
|
32
|
Brennand EA, Wu G, Houlihan S, Globerman D, Gagnon LH, Birch C, Hyakutake M, Carlson KV, Al-Shankiti H, Robert M, Lazare D, Kim-Fine S. Two Intraoperative Techniques for Midurethral Sling Tensioning: A Randomized Controlled Trial. Obstet Gynecol 2020; 136:471-481. [PMID: 32769657 PMCID: PMC7431154 DOI: 10.1097/aog.0000000000004027] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/31/2020] [Revised: 04/29/2020] [Accepted: 06/04/2020] [Indexed: 12/20/2022]
Abstract
OBJECTIVE To evaluate whether the use of a Mayo Scissor as a suburethral spacer compared with a Babcock clamp holding a loop of tape under the urethra results in different rates of abnormal bladder outcomes 12 months after retropubic midurethral sling surgery. METHODS The MUST (Mid-Urethral Sling Tensioning) trial was a block-randomized, double-blind, multicenter clinical trial that allocated women to have their retropubic midurethral slings tensioned by Scissor or Babcock technique. The primary outcome (abnormal bladder) was a composite of persistent stress urinary incontinence (SUI), overactive bladder, and urinary retention. Secondary outcomes included outcomes of the composite, postoperative catheterization, incontinence-related questionnaires, repeat incontinence treatment, and uroflowmetry. Sample size of 159 in each arm (N=318) was planned for a superiority trial, hypothesizing a 10% difference in primary outcome. RESULTS From September 2015 to December 2017, 506 women were screened and 318 were randomized. Baseline characteristics were similar in each arm. At 12 months, 253 (79.6%) women provided information on primary outcome: 40 of 128 (31.3%) patients with midurethral slings tensioned by Scissor experienced abnormal bladder, compared with 23 of 125 (18.4%) of those with midurethral slings tensioned by Babcock (P=.018, relative difference 12.9%). Secondary analyses favored Babcock for median duration of catheterization and the proportions of women experiencing urinary retention requiring sling lysis. Uroflowmetry parameters suggest the Scissor technique is more restrictive. Rates of mesh erosion were lower for the Scissor arm. No differences occurred in proportions of women experiencing patient reported persistent SUI after surgery. CONCLUSION Abnormal bladder outcomes were 12.9% less frequent for women with midurethral slings tensioned by Babcock. Both techniques provided a comparable patient reported cure for SUI at 12 months. Women with midurethral slings tensioned by Scissors experienced more intervention for obstruction, whereas those with midurethral slings tensioned by Babcock experienced higher rates of mesh erosion. This information about how the postoperative courses differ allows surgeons to better counsel patients preoperatively or tailor their choice of technique. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov, NCT02480231. FUNDING SOURCE Boston Scientific.
Collapse
Affiliation(s)
- Erin A Brennand
- Department of Obstetrics & Gynecology, the Department of Community Health Sciences, the Division of Urology, Department of Surgery, Cumming School of Medicine, University of Calgary, Calgary, Alberta, the Department of Obstetrics & Gynecology, University of British Columbia, Vancouver, British Columbia, the Department of Obstetrics & Gynecology, University of Manitoba, Winnipeg, Manitoba, the Department of Obstetrics & Gynecology, University of Toronto, Toronto, Ontario, the Department of Obstetrics & Gynecology, University of Alberta, Edmonton, Alberta, Canada; and the Department of Obstetrics & Gynecology, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia
| | | | | | | | | | | | | | | | | | | | | | | |
Collapse
|
|
33
|
Siegal AR, Huang Z, Gross MD, Mehraban-Far S, Weissbart SJ, Kim JM. Trends of Mesh Utilization for Stress Urinary Incontinence Before and After the 2011 Food and Drug Administration Notification Between FPMRS-Certified and Non-FPMRS-Certified Physicians: A Statewide All-Payer Database Analysis. Urology 2020; 150:151-157. [PMID: 32663554 DOI: 10.1016/j.urology.2020.06.053] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/27/2020] [Revised: 06/22/2020] [Accepted: 06/28/2020] [Indexed: 10/23/2022]
Abstract
OBJECTIVES To investigate the utilization of mesh slings for stress urinary incontinence (SUI) across time - before and after the 2011 US Food and Drug Administration (FDA) public health notification regarding an increase in adverse events related to transvaginal mesh (TVM) for pelvic organ prolapse (POP) repair - and among FPMRS-certified urologists and gynecologists and non-FPMRS counterparts using a statewide database. METHODS The New York Statewide Planning and Research Cooperative System all-payer database was utilized to extract outpatient Current Procedural Terminology procedure codes for SUI mesh sling utilization and revision or removal performed between 2007 and 2015. RESULTS After the 2011 FDA warning on POP with TVM, sling placement decreased by 43% from 5214 cases in 2011 to 2958 in 2015. However, over the study period, the rate of sling revision remained stable relative to total sling placement. The rise and fall in mesh sling usage for SUI was primarily driven by non-FPMRS providers. FPMRS providers performed a higher proportion of sling procedures. The number of FPMRS physicians also increased from 2011 to 2015, and each individual physician had a higher median case volume for sling placements and revisions. CONCLUSION In New York state, utilization of mesh slings for SUI has significantly decreased since the 2011 FDA public health notification, without any specific warning for the utilization of mesh in this setting. This trend was mainly driven by a decrease in mesh usage among non-FPMRS physicians, although the specific causality is likely complex.
Collapse
Affiliation(s)
- Alexandra R Siegal
- Renaissance School of Medicine at Stony Brook University, Stony Brook, NY.
| | - Zhenyue Huang
- Department of Urology, Stony Brook University Medical Center, Stony Brook, NY
| | - Michael D Gross
- Renaissance School of Medicine at Stony Brook University, Stony Brook, NY
| | - Sina Mehraban-Far
- Renaissance School of Medicine at Stony Brook University, Stony Brook, NY
| | - Steven J Weissbart
- Department of Urology, Stony Brook University Medical Center, Stony Brook, NY
| | - Jason M Kim
- Department of Urology, Stony Brook University Medical Center, Stony Brook, NY
| |
Collapse
|
|
34
|
Hermieu N, Schoentgen N, Aoun R, Neveu P, Grassano Y, Egrot C, Kassem A, Xylinas E, Ouzaid I, Hermieu JF. [Surgical management of suburethral sling complications and functional outcomes]. Prog Urol 2020; 30:402-410. [PMID: 32409239 DOI: 10.1016/j.purol.2020.04.022] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/14/2020] [Revised: 04/23/2020] [Accepted: 04/25/2020] [Indexed: 11/26/2022]
Abstract
OBJECTIVES To identify various clinical presentation leading to the diagnosis of mid-urethral sling (MUS) complications and to analyze the functional outcomes after surgical management of these complications. METHOD Retrospective observational monocentric study of all patients treated by MUS section or removal, between December 2005 and October 2019, in a pelviperineology centre. RESULTS During this study, 96 patients were included. MUS complications surgically managed were vaginal mesh exposure (48 %), urethral mesh exposure (17 %), bladder mesh exposure (10 %); dysuria (30 %), pain (6 %), and infection (3 %). The mean time to diagnosis was 2 years. This diagnosis delay was caused by a non-specific and heterogeneous symptomatology. Surgical management consisted in MUS partial removal (79 %) and MUS simple section (21 %) with low perioperative morbidity. At three months follow-up, 36 patients (53 %) had stress urinary incontinence (SUI), including 13 (19 %) de novo (meaning no SUI before MUS section/removal) and 19 (28 %) had overactive bladder, including 9 (13 %) de novo. Half of the patients with SUI after MUS section/removal were able to be treated by a second MUS with a success rate of 83 % at 3 years. CONCLUSION Clinical presentation of MUS complications is heterogeneous. Surgical treatment was associated with low morbidity in our study. Post-operatively, half of the patients had SUI and a second MUS was a relevant treatment option after proper evaluation. LEVEL OF EVIDENCE 4.
Collapse
Affiliation(s)
- N Hermieu
- Service de chirurgie urologique, centre hospitalier universitaire Bichat Claude-Bernard, 46, rue Henri-Huchard, 75018 Paris, France; Université de Paris, Paris, France
| | - N Schoentgen
- Service de chirurgie urologique, centre hospitalier universitaire Bichat Claude-Bernard, 46, rue Henri-Huchard, 75018 Paris, France.
| | - R Aoun
- Service de chirurgie urologique, centre hospitalier universitaire Bichat Claude-Bernard, 46, rue Henri-Huchard, 75018 Paris, France
| | - P Neveu
- Service de chirurgie urologique, centre hospitalier universitaire Bichat Claude-Bernard, 46, rue Henri-Huchard, 75018 Paris, France; Université de Paris, Paris, France
| | - Y Grassano
- Service de chirurgie urologique, centre hospitalier universitaire Bichat Claude-Bernard, 46, rue Henri-Huchard, 75018 Paris, France
| | - C Egrot
- Service de chirurgie urologique, centre hospitalier universitaire Bichat Claude-Bernard, 46, rue Henri-Huchard, 75018 Paris, France
| | - A Kassem
- Service de chirurgie urologique, centre hospitalier universitaire Bichat Claude-Bernard, 46, rue Henri-Huchard, 75018 Paris, France
| | - E Xylinas
- Service de chirurgie urologique, centre hospitalier universitaire Bichat Claude-Bernard, 46, rue Henri-Huchard, 75018 Paris, France; Université de Paris, Paris, France
| | - I Ouzaid
- Service de chirurgie urologique, centre hospitalier universitaire Bichat Claude-Bernard, 46, rue Henri-Huchard, 75018 Paris, France; Université de Paris, Paris, France
| | - J F Hermieu
- Service de chirurgie urologique, centre hospitalier universitaire Bichat Claude-Bernard, 46, rue Henri-Huchard, 75018 Paris, France; Université de Paris, Paris, France
| |
Collapse
|
|
35
|
Sanderson DJ, Cummings S, Sanderson R, Matloubieh J, Eddib A. Risk Factors for Polypropylene Midurethral Sling Extrusion: A Case-Control Study. Urology 2020; 150:201-206. [PMID: 32389819 DOI: 10.1016/j.urology.2020.04.093] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/08/2020] [Revised: 04/14/2020] [Accepted: 04/22/2020] [Indexed: 11/28/2022]
Abstract
OBJECTIVE To identify risk factors associated with surgical revision of midurethral sling (MUS) due to mesh extrusion. MATERIALD AND METHODS This is a case-control study identifying women who underwent primary surgical revision of polypropylene MUS for vaginal mesh extrusion from 2001 to 2016. Cases of surgical revision were compared to a randomly selected control group in a 1:5 ratio. Patient demographics and clinical characteristics were compared and multivariate logistic regression modeling was performed to analyze the relationships between risk factors and vaginal mesh extrusion. RESULTS In total, 64 cases were identified and compared to 400 controls. The average subject was 51.7 years old (range, 30-78) with a body mass index (BMI) of 27.9 kg/m2 (range, 23.6-30.2) at the time of surgical revision. The median time to MUS revision was 318 days (interquartile range, 144-1355 days). Surgical revision was associated with current smokers (odds ratio [OR] = 5.43 [95% confidence interval [CI] 2.86, 10.31]), a BMI under 30 kg/m2 (OR = 4.37 [95% CI = 2.05, 9.36]), age under 55 years (OR = 2.02, [95% CI = 1.13, 3.61]), a retropubic sling (OR = 2.10 [95% CI = 1.14, 3.88]), and fibromyalgia (OR = 3.33 [95% CI 1.12, 9.95]). CONCLUSION Smoking status, age under 55 years, BMI below 30 kg/m2, fibromyalgia, and retropubic approach were factors associated with surgical revision of MUS due to vaginal mesh extrusion. These findings may improve counseling and patient selection.
Collapse
Affiliation(s)
| | | | | | | | - Abeer Eddib
- Western New York Urology Associates, Cheektowaga, NY
| |
Collapse
|
|
36
|
Balancing the possibility of needing a future incontinence procedure versus a future urethral sling revision surgery: a tradeoff analysis for continent women undergoing pelvic organ prolapse surgery. Int Urogynecol J 2020; 31:1141-1150. [PMID: 32125489 DOI: 10.1007/s00192-020-04226-3] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/25/2019] [Accepted: 01/14/2020] [Indexed: 10/24/2022]
Abstract
INTRODUCTION AND HYPOTHESIS Although urinary incontinence surgery has potential benefits such as preventing de novo stress urinary incontinence in women undergoing pelvic organ prolapse (POP) surgery, it comes with the potential cost of overtreatment and complications. We compared future surgery rates in a population cohort of women undergoing vaginal pelvic organ prolapse surgery. METHODS All women undergoing POP repair in California from 2005 to 2011 were identified from the Office of Statewide Health Planning and Development databases. Rates of repeat surgery in those with and without concomitant urethral sling procedures were compared. To control for confounding effects, multivariate mixed effects logistic regression models were constructed to compare each woman's individualized risk of undergoing either sling revision surgery or future incontinence surgery. RESULTS In the cohort, 38,456 underwent a sling procedure at the time of POP repair and 42,858 did not. The future surgery rate was higher for sling-related complications in the POP + sling cohort compared with future incontinence surgery in the POP alone cohort (3.5% versus 3.0% respectively, p < 0.001). The difference persisted in multivariate modeling, where most women (60%) are at a higher risk of requiring sling revision surgery compared with needing a future primary incontinence procedure (40%). CONCLUSIONS Women who undergo vaginal prolapse repair without an incontinence procedure are at a low risk of future incontinence surgery. Women without urinary incontinence who are considering vaginal POP surgery should be informed of the risks and benefits of including a sling procedure.
Collapse
|
|
37
|
Evaluation of the Effect of Surgeon's Operative Volume and Specialty on Likelihood of Revision After Mesh Midurethral Sling Placement. Obstet Gynecol 2020; 133:1099-1108. [PMID: 31135723 PMCID: PMC6553521 DOI: 10.1097/aog.0000000000003275] [Citation(s) in RCA: 10] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/26/2022]
Abstract
One in 20 women undergo midurethral sling revision within 10 years, and annual operative volume of the inserting surgeon is a risk factor. OBJECTIVE: To estimate rates of revision surgery after insertion of mesh midurethral slings and explore whether physician specialty, annual operative volume, or hospital type are associated with this outcome. METHODS: A population-based retrospective cohort of women undergoing midurethral sling procedures over a 13-year interval (2004–2017) in Alberta, Canada was created using administrative health data. The primary outcome was subsequent surgery for revision of midurethral sling, defined by a composite of surgical procedures. Exposures included annual number of midurethral sling procedures performed by the surgeon, surgeon specialty, facility type, patient age, and concomitant prolapse repair. Mixed effects logistic regression using linear spines was used to test a-priori hypothesis that annual surgical volume would be inversely related in a nonlinear fashion to risk of revision. RESULTS: In the cohort of 19,511 women, cumulative rates of revision surgery were 3.84% (95% CI 3.54–4.17) at 5 years and 5.26% (95% CI 4.82–5.74) at 10 years. The first year after midurethral sling placement was the most vulnerable window, with 0.40% (95% CI 0.31–0.49) undergoing revision within 30 days and 2.15% (95% CI 1.95–3.52) within 1 year. Concomitant prolapse repairs (odds ratio [OR] 1.24, 95% CI 1.04–1.48) and surgeon's annual volume were associated with revision. After 50 cases per year, odds of revision declined with each additional case (OR 0.99/case, 95% CI 0.98–0.99, OR 0.91/10 cases, 95% CI 0.84–0.98) and plateaued at 110 cases per year. Surgeon specialty, hospital type, and patient age were not associated with outcome. CONCLUSION: One in 20 women undergo revision surgery within 10 years after midurethral sling placement. Higher physician surgical volume is associated with decreased risk, with the decline occurring at a threshold of 50 cases annually. Minimum caseload parameters for surgeons performing midurethral sling procedures may improve quality of these procedures.
Collapse
|
|
38
|
Welk B, Reid J, Kelly E, Wu YM. Association of Transvaginal Mesh Complications With the Risk of New-Onset Depression or Self-harm in Women With a Midurethral Sling. JAMA Surg 2020; 154:358-360. [PMID: 30624560 DOI: 10.1001/jamasurg.2018.4644] [Citation(s) in RCA: 12] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/14/2022]
Affiliation(s)
- Blayne Welk
- Department of Surgery, Western University, London, Ontario, Canada.,Department of Epidemiology and Biostatistics, Western University, London, Ontario, Canada.,Institute for Clinical Evaluative Sciences, London, Ontario, Canada
| | - Jennifer Reid
- Institute for Clinical Evaluative Sciences, London, Ontario, Canada
| | - Erin Kelly
- Department of Obstetrics & Gynecology, University of Edmonton, Edmonton, Alberta, Canada
| | - You Maria Wu
- Department of Obstetrics & Gynecology, Western University, London, Ontario, Canada
| |
Collapse
|
|
39
|
Bueno Garcia Reyes P, Hashim H. Mesh complications: best practice in diagnosis and treatment. Ther Adv Urol 2020; 12:1756287220942993. [PMID: 32754226 PMCID: PMC7378717 DOI: 10.1177/1756287220942993] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/09/2020] [Accepted: 06/17/2020] [Indexed: 11/29/2022] Open
Abstract
Mesh was a promising, minimally invasive, and 'gold standard' treatment for urinary stress incontinence. Time has shown that complications from these devices can happen early, or even several years, after mesh placement and can be catastrophic. Pain, erosion, voiding dysfunction, infection, recurrent UTIs [urinary tract infections (UTIs)], fistulae, organ perforation, bleeding, vaginal scarring, neuromuscular alterations, LUTS (lower urinary tract symptoms), bowel complications and even immune disorders have been linked to mesh. Various tools, such as imaging, endoscopic and functional studies, are available for diagnosis of mesh complications. Since the spectrum of complications is wide, involvement of other specialties is usually beneficial in the diagnosis and management of these complications. There is still much to learn on the accuracy and utility of diagnostic studies in each type of complication. Evidence on the best diagnostic and treatment pathways for these complications is scarce but continuously growing as information is being reported, and we continue to gain expertise in dealing with patients affected by mesh. Treatment options include conservative and medical management initially and then open or minimally invasive surgical procedure approaches. This article will describe diagnostic and treatment pathways for mesh complications.
Collapse
Affiliation(s)
| | - Hashim Hashim
- Bristol Urological Institute, Southmead
Hospital, Bristol BS10 5NB, UK
| |
Collapse
|
|
40
|
Berger AA, Tan-Kim J, Menefee SA. Surgeon volume and reoperation risk after midurethral sling surgery. Am J Obstet Gynecol 2019; 221:523.e1-523.e8. [PMID: 31526790 DOI: 10.1016/j.ajog.2019.09.006] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/31/2018] [Revised: 09/04/2019] [Accepted: 09/10/2019] [Indexed: 12/26/2022]
Abstract
BACKGROUND Emerging research supports that fewer complications occur in patients who undergo surgery by higher surgical volume surgeons. The midurethral sling surgery has been involved in recent warnings and litigation, which further supports a need to understand features that enhance its safety and efficacy. OBJECTIVE The purpose of this study was to measure the impact of a surgeon's volume on their patient's rate of reoperation after midurethral sling surgery. STUDY DESIGN This was a retrospective cohort study that evaluated all surgeons who performed synthetic mesh midurethral sling surgery for stress urinary incontinence at a large managed care organization with >4.5 million members from 2005-2016. Physicians Current Procedural Terminology and International Classification of Diseases, version 9/10, codes were used to identify the procedures and the reoperations that were performed. The system-wide medical record was queried for demographic and perioperative data. The primary outcome was the overall reoperation rate after midurethral sling surgery. Concentration curves were used to identify the impact of a surgeon's surgical volume on their rate of reoperation. Demographics, characteristics, and reoperation of patients were compared with the use of chi-square test for categoric variables and Wilcoxon rank sum test for continuous variables. Poisson regression models with a robust error variance were used to calculate the unadjusted and the adjusted risk ratios of reoperation with the use of age, body mass index, marital status, race, parity, vaginal estrogen use, sling type, smoking, diabetes mellitus, and menopausal status as covariates. RESULTS Two hundred twenty-seven surgeons performed 13,404 midurethral sling surgeries over the study period; patients had a mean of 4.4 years of follow up. Higher-volume surgeons (>40 procedures/year, ≥95th percentile) performed 47% of the surgeries in this cohort and had an overall lower rate of reoperation (3.6% vs 4.2%; 95% confidence interval, 0.67-0.94; P=.04) compared with lower-volume surgeons. Higher-volume surgeons had a lower rate of reoperation for surgical failure (2.7% vs 3.6%; 95% confidence interval, 0.55-0.92; P<.01). Rates of reoperation for complications were similar between the 2 groups (1.1% vs 0.9%; 95% confidence interval, 0.82-1.13; P=.32). For patients whose condition required a reoperation secondary to complication, the rates of reoperation for urinary retention (0.9% vs 0.6%; P=.06), mesh exposure (0.2% vs 0.3%; P=.31), hemorrhage/bleeding (0.1% vs 0.0%; P=.11), pain (0.1% vs 0.1%; P=.52), and infection (0.0% vs 0.0%; P=.37) did not differ between higher- and lower-volume surgeons. The risk ratio for reoperation that compared higher- and lower-volume surgeons was 0.83 (95% confidence interval, 0.67-0.98; P=.01) in the adjusted model. CONCLUSION Although the reoperation rates were low for both higher- and lower-volume surgeons, higher-volume surgeons had lower overall rates of reoperation after midurethral sling surgery. This effect is seen most dramatically in reoperation for surgical failure, in which patients who have surgery with a higher-volume surgeon are 25% less likely to have postoperative stress urinary incontinence that leads to reoperation.
Collapse
Affiliation(s)
- Alexander A Berger
- Division of Female Pelvic Medicine and Reconstructive Surgery, Department of OB/GYN, Kaiser Permanente-San Diego, San Diego, CA; Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics, Gynecology and Reproductive Science, University of California San Diego, San Diego, CA.
| | - Jasmine Tan-Kim
- Division of Female Pelvic Medicine and Reconstructive Surgery, Department of OB/GYN, Kaiser Permanente-San Diego, San Diego, CA
| | - Shawn A Menefee
- Division of Female Pelvic Medicine and Reconstructive Surgery, Department of OB/GYN, Kaiser Permanente-San Diego, San Diego, CA
| |
Collapse
|
|
41
|
Long-term Risk of Reoperation After Synthetic Mesh Midurethral Sling Surgery for Stress Urinary Incontinence. Obstet Gynecol 2019; 134:1047-1055. [DOI: 10.1097/aog.0000000000003526] [Citation(s) in RCA: 18] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/26/2022]
|
|
42
|
Delorme E. What transvaginal meshes (TVM) surgery tells us about conflicts of interest. J Gynecol Obstet Hum Reprod 2019; 49:101636. [PMID: 31520751 DOI: 10.1016/j.jogoh.2019.101636] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/19/2019] [Accepted: 09/10/2019] [Indexed: 11/19/2022]
|
|
43
|
Clancy A. Opinion de comité No 387 - La bandelette sous-urétrale dans le traitement de l'incontinence urinaire à l'effort. JOURNAL OF OBSTETRICS AND GYNAECOLOGY CANADA 2019; 41:1392-1394. [DOI: 10.1016/j.jogc.2019.01.015] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/29/2022]
|
|
44
|
Wu YM, Welk B. Revisiting current treatment options for stress urinary incontinence and pelvic organ prolapse: a contemporary literature review. Res Rep Urol 2019; 11:179-188. [PMID: 31355157 PMCID: PMC6590839 DOI: 10.2147/rru.s191555] [Citation(s) in RCA: 16] [Impact Index Per Article: 2.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/05/2019] [Accepted: 05/20/2019] [Indexed: 02/02/2023] Open
Abstract
Stress urinary incontinence (SUI) and pelvic organ prolapse (POP) affect many women in their lifetime. In this review, we describe and evaluate the latest treatment options for SUI and POP, including the controversy around transvaginal mesh (TVM) use. Growing evidence supports the utilization of pelvic floor muscle training as first-line treatment for both SUI and POP. Vaginal pessaries continue to be an effective and reversible option to manage SUI and POP symptoms. The midurethral sling remains the gold standard for surgical treatment of SUI, although patients and clinicians should acknowledge the potentially serious complications of TVM. Burch urethropexy and pubovaginal sling offer good SUI cure and may be preferred in women wishing to avoid mesh implants; however, their operative morbidities and more challenging surgical approach may limit their use. Site-specific cystocele or rectocele repairs may be indicated for isolated anterior or posterior vaginal compartment prolapse; however, in women with more severe POP, evidence supports using a vaginal native-tissue repair involving apical suspension as the primary surgical technique. Although abdominal and laparoscopic sacrocolpopexies are both effective in treating POP, their failure and mesh complication rates increase with time. There is insufficient evidence to support the widespread use of uterine-preserving surgical POP repairs at present due to the lack of long-term data. Routine TVM use is not recommended in POP surgeries and should only be considered on a case-by-case basis by trained surgeons, primarily in women with multiple risk factors for POP recurrence. In general, clinicians should individualize SUI and POP treatment options for women based on their symptoms, comorbidities, and risk factors for mesh-related complications.
Collapse
Affiliation(s)
- You Maria Wu
- Department of Obstetrics and Gynecology, London Health Sciences Centre, London, Ontario, Canada
| | - Blayne Welk
- Department of Surgery and Epidemiology & Biostatistics, Western University, London, Ontario, Canada
| |
Collapse
|
|
45
|
Clancy A. Committee Opinion No. 387-Mid-Urethral Slings for Stress Urinary Incontinence. JOURNAL OF OBSTETRICS AND GYNAECOLOGY CANADA 2019; 41:1389-1391. [PMID: 30930102 DOI: 10.1016/j.jogc.2018.12.020] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/27/2022]
|
|
46
|
|
|
47
|
Kershaw V, Nicholson R, Ballard P, Khunda A, Puthuraya S, Gouk E. Outcome of surgical management for midurethral sling complications: a multicentre retrospective cohort study. Int Urogynecol J 2019; 31:329-336. [DOI: 10.1007/s00192-018-3853-6] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/11/2018] [Accepted: 12/07/2018] [Indexed: 12/01/2022]
|
|
48
|
Clancy AA, Gauthier I, Ramirez FD, Hickling D, Pascali D. Predictors of sling revision after mid-urethral sling procedures: a case-control study. BJOG 2018; 126:419-426. [DOI: 10.1111/1471-0528.15470] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 08/29/2018] [Indexed: 11/29/2022]
Affiliation(s)
- AA Clancy
- Division of Urogynecology; Department of Obstetrics and Gynecology; University of Ottawa; Ottawa ON Canada
| | - I Gauthier
- Division of Urogynecology; Department of Obstetrics and Gynecology; University of Ottawa; Ottawa ON Canada
| | - FD Ramirez
- School of Epidemiology and Public Health; University of Ottawa; Ottawa ON Canada
- Division of Cardiology; University of Ottawa Heart Institute; Ottawa ON Canada
| | - D Hickling
- Division of Urology; Department of Surgery; University of Ottawa; Ottawa ON Canada
- The Ottawa Hospital Research Institute; Ottawa ON Canada
| | - D Pascali
- Division of Urogynecology; Department of Obstetrics and Gynecology; University of Ottawa; Ottawa ON Canada
| |
Collapse
|
|
49
|
Goodall EJ, Cartwright R, Stratta EC, Jackson SR, Price N. Outcomes after laparoscopic removal of retropubic midurethral slings for chronic pain. Int Urogynecol J 2018; 30:1323-1328. [PMID: 30229269 DOI: 10.1007/s00192-018-3756-6] [Citation(s) in RCA: 14] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/21/2018] [Accepted: 08/14/2018] [Indexed: 11/24/2022]
Abstract
INTRODUCTION AND HYPOTHESIS Midurethral slings (MUS) are an established treatment for stress urinary incontinence (SUI), with good objective outcomes and low rates of complications. However, large population-based registry studies highlighted long-term complications from polypropylene slings including erosion, dyspareunia and chronic pain. With recent highly negative media coverage, many women are presenting with chronic pain attributed to the mesh to request complete removal. The available literature provides limited evidence on safety, symptom resolution and incontinence following MUS removal. METHODS We identified all patients who underwent laparoscopic removal of MUS mesh at our hospital between 2011 and 2016. We extracted data from medical records to assess operative safety and contacted all patients by questionnaire that incorporated pain scales, symptom severity and satisfaction. RESULTS A total of 56 women were assessed. Removal occurred at a median of 44 months following sling insertion (range 3-192). Mean operative time was 74 min (range 44-132). Two patients were returned to theatre (one at 24 hours and one at 14 days) to evacuate a retropubic haematoma, but no visceral injuries occurred. The median inpatient stay was 2 days (range 1-7). Of the 46% of patients who returned the questionnaire (n = 26), 88% said they would recommend the procedure. There was a median 6-point decrease in pain scores (10-point numerical scale, p < 0.0001); 44.6% reported worsening SUI, more common with removal of the suburethral mesh [odds ratio (OR) 10.72 95% confidence interval (CI) 1.10-104]. CONCLUSIONS Laparoscopic removal of MUS is feasible and effective but carries a risk of worsening SUI.
Collapse
Affiliation(s)
- Elizabeth J Goodall
- John Radcliffe Hospital, Oxford University Hospitals, Headley Way, Headington, Oxford, OX3 9DU, UK.
| | - Rufus Cartwright
- John Radcliffe Hospital, Oxford University Hospitals, Headley Way, Headington, Oxford, OX3 9DU, UK
| | - Emily C Stratta
- John Radcliffe Hospital, Oxford University Hospitals, Headley Way, Headington, Oxford, OX3 9DU, UK
| | - Simon R Jackson
- John Radcliffe Hospital, Oxford University Hospitals, Headley Way, Headington, Oxford, OX3 9DU, UK
| | - Natalia Price
- John Radcliffe Hospital, Oxford University Hospitals, Headley Way, Headington, Oxford, OX3 9DU, UK
| |
Collapse
|
|
50
|
Punjani N, Lanting B, McClure JA, Winick-Ng J, Welk B. The Impact of Common Urologic Complications on the Risk of a Periprosthetic Joint Infection. J Bone Joint Surg Am 2018; 100:1517-1523. [PMID: 30180061 DOI: 10.2106/jbjs.17.01405] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/01/2023]
Abstract
BACKGROUND Periprosthetic infections after total hip arthroplasty (THA) or total knee arthroplasty (TKA) are substantial complications, and there are conflicting reports of their association with urologic complications. Our objective was to determine whether urinary tract infection (UTI) and acute urinary retention (AUR) are significant risk factors for joint infections after THA or TKA. METHODS We performed a population-based, retrospective cohort study of patients who were ≥66 years old when they underwent an initial THA or TKA between April 2003 and March 2013. Investigated exposures included a UTI presenting for treatment within 2 years after joint replacement, as well as AUR within 30 days after THA or TKA. The primary outcome was joint infection requiring hospital admission following THA or TKA (which had to occur within 2.25 years after THA or TKA for the UTI exposure or 120 days for the AUR exposure). RESULTS A total of 113,061 patients met the inclusion criteria and had arthroplasties (44,495 THAs and 68,566 TKAs) during the study period. The median age was 74 years (interquartile range [IQR], 70 to 79 years). Of those patients, 28,256 (25.0%) had at least 1 UTI and they were more likely to be older and female; to have had previous antibiotic exposure, cystoscopy, or urinary retention; and to have atrial fibrillation. Most of those UTIs were coded as nonspecific UTI, and the patient was seen for outpatient treatment in a non-emergency department setting. A total of 2,516 patients (2.2%) had AUR within 30 days of the procedure. Those patients were more likely to be older and male, to have medical comorbidities, to have had previous transurethral procedures or cystoscopy and previous urology visits, and to have received a general anesthetic during their procedure. A total of 1,262 patients (1.1%) had joint infection requiring hospital admission. In multivariate Cox regression analysis, UTI was associated with an increased risk of joint infection (hazard ratio [HR], 1.21 [95% confidence interval (CI), 1.14 to 1.28]; p < 0.01). However multivariate analysis did not demonstrate an association between AUR and joint infection (HR, 0.99 [95% CI, 0.60 to 1.64]; p = 0.98). CONCLUSIONS UTI was associated with increased risk of hip or knee periprosthetic joint infection, whereas AUR was not a significant risk factor. Timely and appropriate treatment of symptomatic UTIs in this patient population may be important to prevent periprosthetic joint infection. LEVEL OF EVIDENCE Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.
Collapse
Affiliation(s)
- Nahid Punjani
- Departments of Surgery (N.P., B.L., and B.W.) and Epidemiology and Biostatistics (B.W.), Western University, London, Ontario, Canada
| | - Brent Lanting
- Departments of Surgery (N.P., B.L., and B.W.) and Epidemiology and Biostatistics (B.W.), Western University, London, Ontario, Canada
| | - J Andrew McClure
- Institute for Clinical Evaluative Sciences, London, Ontario, Canada
| | | | - Blayne Welk
- Departments of Surgery (N.P., B.L., and B.W.) and Epidemiology and Biostatistics (B.W.), Western University, London, Ontario, Canada.,Institute for Clinical Evaluative Sciences, London, Ontario, Canada
| |
Collapse
|