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Yagi K, Takeyama M, Doi Y, Kuwata T, Kashihara H, Kato C. Is Posterior Transvaginal Mesh Surgery Using PTFE Mesh ORIHIME Effective and Safe for Advanced Posterior Vaginal Prolapse? Int J Urol 2025; 32:560-566. [PMID: 39945102 DOI: 10.1111/iju.70008] [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: 10/09/2024] [Revised: 01/06/2025] [Accepted: 02/02/2025] [Indexed: 04/26/2025]
Abstract
OBJECTIVES To examine the efficacy and safety of posterior tension-free vaginal mesh (TVM-P) surgery using polytetrafluoroethylene (PTFE) mesh (ORIHIME) for advanced posterior vaginal prolapse. METHODS A retrospective cohort study was conducted involving patients who underwent TVM-P surgery with PTFE mesh for pelvic organ prolapse quantification stage III or IV posterior vaginal prolapse between December 2018 and March 2023. All patients were followed for a minimum of 1 year postoperatively. The primary outcome was the recurrence rate in the operated compartment. Secondary outcomes comprised recurrence in other pelvic compartments, mesh-related complications, and an analysis of risk factors for recurrence. RESULTS Seventy-one patients underwent TVM-P surgery during the study period. The recurrence rate in the operated compartment was 4.2%, while the overall recurrence rate was 18.3%. Eleven cases of recurrence occurred within the first year; 13 cases were observed within 3 years postsurgery. Patients who experienced recurrence in other compartments had a significantly higher incidence of preoperative Ba point score ≥ -1 versus the nonrecurrence group. Preoperative Ba point score ≥ -1 was associated with a higher risk of recurrence in other compartments (crude odds ratio: 4.17, 95% confidence interval: 1.03-26.7; adjusted odds ratio: 2.58, 95% confidence interval: 0.56-11.8). CONCLUSIONS The recurrence rate in the operated compartment following TVM-P surgery for advanced rectoceles or enteroceles was 4.2%. These findings suggest that TVM-P surgery using PTFE mesh may be an effective surgical option for treating severe posterior vaginal pelvic organ prolapse.
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Affiliation(s)
- Kazunobu Yagi
- Urogynecology Center, First Towakai Hospital, Takatsuki City, Osaka, Japan
| | - Masami Takeyama
- Urogynecology Center, First Towakai Hospital, Takatsuki City, Osaka, Japan
| | - Yukiko Doi
- Urogynecology Center, First Towakai Hospital, Takatsuki City, Osaka, Japan
| | - Tomoko Kuwata
- Urogynecology Center, First Towakai Hospital, Takatsuki City, Osaka, Japan
| | - Hiromi Kashihara
- Urogynecology Center, First Towakai Hospital, Takatsuki City, Osaka, Japan
| | - Chikako Kato
- Urogynecology Center, First Towakai Hospital, Takatsuki City, Osaka, Japan
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Fındık RB, Doğanay M, Aksakal OS, Çoşkun ZY, Karakaya J. A novel suturing technique for natural tissue repair in cystocele treatment. BMC Womens Health 2024; 24:474. [PMID: 39210362 PMCID: PMC11360469 DOI: 10.1186/s12905-024-03317-3] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/23/2024] [Accepted: 08/14/2024] [Indexed: 09/04/2024] Open
Abstract
BACKGROUND Recently, natural tissue repair has become popular in the treatment of pelvic organ prolapsed. In this study, we compared patients who underwent cystocele repair with the rug-weaving plication technique, a natural tissue repair method implemented since 2022 for anterior prolapse, with those treated using conventional colporrhaphy. METHODS We retrospectively reviewed the data of 65 patients who underwent anterior vaginal wall repair with the rug-weaving plication technique (n = 33, Group 1) or conventional colporrhaphy (n = 32, Group 2). We recorded the patients' clinicodemographic and surgical data. At the 6-month postoperative follow-up, we assessed patients' complaints, degree of prolapse (using the simplified Pelvic Organ Prolapse Quantification system), and pelvic floor muscle strength (using the Modified Oxford Score). Anterior vaginal wall thickness was measured using transvaginal ultrasonography. We compared clinicodemographic and surgical data and postoperative outcomes between the two groups. RESULTS The two groups were comparable in terms of age (p = 0.326), number of pregnancies (p = 0.307), number of parities (p = 0.555), preoperative anterior wall simplified Pelvic Organ Prolapse Quantification grade (p = 0.380), preoperative apical prolapse simplified Pelvic Organ Prolapse Quantification grade (p = 0.518), postoperative Modified Oxford Score (p = 0.857), operation time (p = 0.809), postoperative haemoglobin (p = 0.674), and amount of bleeding (p = 0.951). Compared with Group 2, Group 1 had significantly higher postoperative anterior vaginal wall thickness (p < 0.001) and significantly lower postoperative anterior wall simplified Pelvic Organ Prolapse Quantification grade (p < 0.001). CONCLUSIONS The rug-weaving plication technique may offer a viable alternative for cystocele repair without mesh, using natural tissue and potentially reducing mesh-related complications and recurrence rates. CLINICAL TRIAL NUMBER NCT06410469 (03/05/2024).
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Affiliation(s)
- Rahime Bedir Fındık
- Department of Obstetrics and Gynecology, Ankara City Hospital (MH5), , Bilkent/Ankara, Turkey.
| | - Melike Doğanay
- Department of Obstetrics and Gynecology, Ankara City Hospital (MH5), , Bilkent/Ankara, Turkey
| | - Orhan Seyfi Aksakal
- Department of Obstetrics and Gynecology, Ankara City Hospital (MH5), , Bilkent/Ankara, Turkey
| | - Zuhal Yapıcı Çoşkun
- Department of Obstetrics and Gynecology, Ankara City Hospital (MH5), , Bilkent/Ankara, Turkey
| | - Jale Karakaya
- Department of Biostatistics, Hacettepe University, Ankara, Turkey
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Yeung E, Baessler K, Christmann-Schmid C, Haya N, Chen Z, Wallace SA, Mowat A, Maher C. Transvaginal mesh or grafts or native tissue repair for vaginal prolapse. Cochrane Database Syst Rev 2024; 3:CD012079. [PMID: 38477494 PMCID: PMC10936147 DOI: 10.1002/14651858.cd012079.pub2] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 03/14/2024]
Abstract
BACKGROUND Pelvic organ prolapse is the descent of one or more of the pelvic organs (uterus, vaginal apex, bladder, or bowel) into the vagina. In recent years, surgeons have increasingly used grafts in transvaginal repairs. Graft material can be synthetic or biological. The aim is to reduce prolapse recurrence and surpass the effectiveness of traditional native tissue repair (colporrhaphy) for vaginal prolapse. This is a review update; the previous version was published in 2016. OBJECTIVES To determine the safety and effectiveness of transvaginal mesh or biological grafts compared to native tissue repair or other grafts in the surgical treatment of vaginal prolapse. SEARCH METHODS We searched the Cochrane Incontinence Group Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and two clinical trials registers (March 2022). SELECTION CRITERIA Randomised controlled trials (RCTs) comparing different types of vaginal repair (mesh, biological graft, or native tissue). DATA COLLECTION AND ANALYSIS Two review authors independently selected trials, assessed risk of bias, and extracted data. The primary outcomes were awareness of prolapse, repeat surgery, and recurrent prolapse on examination. MAIN RESULTS We included 51 RCTs (7846 women). The certainty of the evidence was largely moderate (ranging from very low to moderate). Transvaginal permanent mesh versus native tissue repair Awareness of prolapse at six months to seven years was less likely after mesh repair (risk ratio (RR) 0.83, 95% confidence interval (CI) 0.73 to 0.95; I2 = 34%; 17 studies, 2932 women; moderate-certainty evidence). This suggests that if 23% of women are aware of prolapse after native tissue repair, between 17% and 22% will be aware of prolapse after permanent mesh repair. Rates of repeat surgery for prolapse were lower in the mesh group (RR 0.71, 95% CI 0.53 to 0.95; I2 = 35%; 17 studies, 2485 women; moderate-certainty evidence). There was no evidence of a difference between the groups in rates of repeat surgery for incontinence (RR 1.03, 95% CI 0.67 to 1.59; I2 = 0%; 13 studies, 2206 women; moderate-certainty evidence). However, more women in the mesh group required repeat surgery for the combined outcome of prolapse, stress incontinence, or mesh exposure (RR 1.56, 95% CI 1.07 to 2.26; I2 = 54%; 27 studies, 3916 women; low-certainty evidence). This suggests that if 7.1% of women require repeat surgery after native tissue repair, between 7.6% and 16% will require repeat surgery after permanent mesh repair. The rate of mesh exposure was 11.8% and surgery for mesh exposure was 6.1% in women who had mesh repairs. Recurrent prolapse on examination was less likely after mesh repair (RR 0.42, 95% CI 0.32 to 0.55; I2 = 84%; 25 studies, 3680 women; very low-certainty evidence). Permanent transvaginal mesh was associated with higher rates of de novo stress incontinence (RR 1.50, 95% CI 1.19 to 1.88; I2 = 0%; 17 studies, 2001 women; moderate-certainty evidence) and bladder injury (RR 3.67, 95% CI 1.63 to 8.28; I2 = 0%; 14 studies, 1997 women; moderate-certainty evidence). There was no evidence of a difference between the groups in rates of de novo dyspareunia (RR 1.22, 95% CI 0.83 to 1.79; I2 = 27%; 16 studies, 1308 women; moderate-certainty evidence). There was no evidence of a difference in quality of life outcomes; however, there was substantial heterogeneity in the data. Transvaginal absorbable mesh versus native tissue repair There was no evidence of a difference between the two methods of repair at two years for the rate of awareness of prolapse (RR 1.05, 95% CI 0.77 to 1.44; 1 study, 54 women), rate of repeat surgery for prolapse (RR 0.47, 95% CI 0.09 to 2.40; 1 study, 66 women), or recurrent prolapse on examination (RR 0.53, 95% CI 0.10 to 2.70; 1 study, 66 women). The effect of either form of repair was uncertain for bladder-related outcomes, dyspareunia, and quality of life. Transvaginal biological graft versus native tissue repair There was no evidence of a difference between the groups at one to three years for the outcome awareness of prolapse (RR 1.06, 95% CI 0.73 to 1.56; I2 = 0%; 8 studies, 1374 women; moderate-certainty evidence), repeat surgery for prolapse (RR 1.15, 95% CI 0.75 to 1.77; I2 = 0%; 6 studies, 899 women; moderate-certainty evidence), and recurrent prolapse on examination (RR 0.96, 95% CI 0.71 to 1.29; I2 = 53%; 9 studies, 1278 women; low-certainty evidence). There was no evidence of a difference between the groups for dyspareunia or quality of life. Transvaginal permanent mesh versus any other permanent mesh or biological graft vaginal repair Sparse reporting of primary outcomes in both comparisons significantly limited any meaningful analysis. AUTHORS' CONCLUSIONS While transvaginal permanent mesh is associated with lower rates of awareness of prolapse, repeat surgery for prolapse, and prolapse on examination than native tissue repair, it is also associated with higher rates of total repeat surgery (for prolapse, stress urinary incontinence, or mesh exposure), bladder injury, and de novo stress urinary incontinence. While the direction of effects and effect sizes are relatively unchanged from the 2016 version of this review, the certainty and precision of the findings have all improved with a larger sample size. In addition, the clinical relevance of these data has improved, with 10 trials reporting 3- to 10-year outcomes. The risk-benefit profile means that transvaginal mesh has limited utility in primary surgery. Data on the management of recurrent prolapse are of limited quality. Given the risk-benefit profile, we recommend that any use of permanent transvaginal mesh should be conducted under the oversight of the local ethics committee in compliance with local regulatory recommendations. Data are not supportive of absorbable meshes or biological grafts for the management of transvaginal prolapse.
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Affiliation(s)
- Ellen Yeung
- Royal Brisbane and Women's Hospital, Brisbane, Australia
- Gold Coast Health, Gold Coast, Australia
| | | | | | - Nir Haya
- Rambam Medical Centre, and Ruth and Bruce Rappaport School of Medicine, Technion-Israel Institute of Technology, Haifa, Israel
| | | | - Sheila A Wallace
- Evidence Synthesis Group, Population Health Sciences Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK
| | - Alex Mowat
- Greenslopes Hospital, Brisbane, Australia
| | - Christopher Maher
- Wesley and Royal Brisbane and Women's Hospitals, Brisbane, Australia
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Guler Z, Kaestner LA, Vodegel E, Ras L, Jeffrey S, Roovers JP. Two-Year Preclinical Evaluation of Long-Term Absorbable Poly-4-hydroxybutyrate Scaffold for Surgical Correction of Pelvic Organ Prolapse. Int Urogynecol J 2024; 35:713-722. [PMID: 38430238 PMCID: PMC11024044 DOI: 10.1007/s00192-023-05720-0] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/06/2023] [Accepted: 12/14/2023] [Indexed: 03/03/2024]
Abstract
INTRODUCTION AND HYPOTHESIS Fully absorbable implants may be an alternative to permanent meshes in the correction pf pelvic organ prolapse (POP) as they may reduce adverse events by promoting tissue regeneration and collagen metabolism. This study was aimed at evaluating the long-term host and biomechanical response to a fully absorbable poly-4-hydroxybutyrate (P4HB) scaffold in comparison with polypropylene (PP) mesh. METHODS Poly-4-hydroxybutyrate scaffold (n = 16) and PP mesh (n = 16) were surgically implanted in the posterior vaginal wall of parous female Dohne Merino sheep. Vaginal explants were evaluated in terms of gross necropsy, host response (immune response, collagen deposition, tissue regeneration), biomechanics, and degradation of P4HB at 12 and 24 months post-implantation. RESULTS Gross necropsy revealed no infection or fluid collection using P4HB or PP. At 12 months, exposures were observed with both P4HB (3 out of 8) and PP (4 out of 8), whereas at 24 months, exposures were observed only with PP (4 out of 8). The tensile stiffness of the P4HB explants was maintained over time despite complete absorption of P4HB. The collagen amount of the vaginal tissue after P4HB implantation increased over time and was significantly higher than PP at 24 months. P4HB scaffolds exhibited significantly lower myofibroblast differentiation than PP meshes at 24 months. CONCLUSIONS The P4HB scaffold allowed for gradual load transfer to the vaginal wall and resulted in mechanically self-sufficient tissue. P4HB scaffold had a more favorable host response than PP mesh, with higher collagen content, lower myofibroblastic differentiation, and no exposures at 24 months. P4HB scaffolds have potential as an alternative to permanent implants in treating POP.
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Affiliation(s)
- Zeliha Guler
- Department of Obstetrics and Gynaecology, Amsterdam UMC - location AMC, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.
- Amsterdam Reproduction and Development, Amsterdam, The Netherlands.
| | - Lisa Ann Kaestner
- Department of Urology, Groote Schuur Hospital, University of Cape Town, Cape Town, South Africa
| | - Eva Vodegel
- Department of Obstetrics and Gynaecology, Amsterdam UMC - location AMC, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands
- Amsterdam Reproduction and Development, Amsterdam, The Netherlands
| | - Lamees Ras
- Department of Obstetrics and Gynecology, Groote Schuur Hospital, University of Cape Town, Cape Town, South Africa
| | - Stephen Jeffrey
- Department of Obstetrics and Gynecology, Groote Schuur Hospital, University of Cape Town, Cape Town, South Africa
| | - Jan Paul Roovers
- Department of Obstetrics and Gynaecology, Amsterdam UMC - location AMC, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands
- Amsterdam Reproduction and Development, Amsterdam, The Netherlands
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Padoa A, Braga A, Fligelman T, Athanasiou S, Phillips C, Salvatore S, Serati M. European Urogynaecological Association Position Statement: Pelvic Organ Prolapse Surgery. UROGYNECOLOGY (PHILADELPHIA, PA.) 2023; 29:703-716. [PMID: 37490710 DOI: 10.1097/spv.0000000000001396] [Citation(s) in RCA: 6] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 07/27/2023]
Affiliation(s)
| | | | | | - Stavros Athanasiou
- Urogynecology Unit, 1st Department of Obstetrics and Gynecology, National and Kapodistrian University of Athens, Athens, Greece
| | - Christian Phillips
- Basingstoke and North Hampshire Hospital, Urogynaecology, Basingstoke, Hampshire, United Kingdom
| | - Stefano Salvatore
- Obstetrics and Gynecology Unit, Vita-Salute University and IRCCS San Raffaele Hospital, Scientific Institute, Milan, Italy
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6
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Diedrich CM, Guler Z, Hympanova L, Vodegel E, Zündel M, Mazza E, Deprest J, Roovers JP. Evaluation of the short-term host response and biomechanics of an absorbable poly-4-hydroxybutyrate scaffold in a sheep model following vaginal implantation. BJOG 2021; 129:1039-1049. [PMID: 34865300 PMCID: PMC9303173 DOI: 10.1111/1471-0528.17040] [Citation(s) in RCA: 13] [Impact Index Per Article: 3.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/18/2021] [Revised: 11/19/2021] [Accepted: 11/30/2021] [Indexed: 12/01/2022]
Abstract
Objective To evaluate the host‐ and biomechanical response to a fully absorbable poly‐4‐hydroxybutyrate (P4HB) scaffold in comparison with the response to polypropylene (PP) mesh. Design In vivo animal experiment. Setting KU Leuven Center for Surgical Technologies. Population Fourteen parous female Mule sheep. Methods P4HB scaffolds were surgically implanted in the posterior vaginal wall of sheep. The comparative PP mesh data were obtained from an identical study protocol performed previously. Main outcome measures Gross necropsy, host response and biomechanical evaluation of explants, and the in vivo P4HB scaffold degradation were evaluated at 60‐ and 180‐days post‐implantation. Data are reported as mean ± standard deviation (SD) or standard error of the mean (SEM). Results Gross necropsy revealed no implant‐related adverse events using P4HB scaffolds. The tensile stiffness of the P4HB explants increased at 180‐days (12.498 ± 2.66 N/mm SEM [p =0.019]) as compared to 60‐days (4.585 ± 1.57 N/mm) post‐implantation, while P4HB degraded gradually. P4HB scaffolds exhibited excellent tissue integration with dense connective tissue and a moderate initial host response. P4HB scaffolds induced a significantly higher M2/M1 ratio (1.70 ± 0.67 SD, score 0–4), as compared to PP mesh(0.99 ± 0.78 SD, score 0–4) at 180‐days. Conclusions P4HB scaffold facilitated a gradual load transfer to vaginal tissue over time. The fully absorbable P4HB scaffold, in comparison to PP mesh, has a favorable host response with comparable load‐bearing capacity. If these results are also observed at longer follow‐up in‐vivo, a clinical study using P4HB for vaginal POP surgery may be warranted to demonstrate efficacy. Tweetable Abstract Degradable vaginal P4HB implant might be a solution for treatment of POP. Degradable vaginal P4HB implant might be a solution for treatment of POP.
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Affiliation(s)
- Chantal M Diedrich
- Department of Obstetrics and Gynaecology, Center for Reproductive Medicine (AMC), Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands
| | - Zeliha Guler
- Department of Obstetrics and Gynaecology, Center for Reproductive Medicine (AMC), Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands
| | - Lucie Hympanova
- Centre for Surgical Technologies, Biomedical Sciences Group, KU Leuven, Leuven, Belgium.,Third Faculty of Medicine, Institute for the Care of Mother and Child, Charles University, Prague, Czech Republic
| | - Eva Vodegel
- Department of Obstetrics and Gynaecology, Center for Reproductive Medicine (AMC), Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands
| | - Manuel Zündel
- Institute of Mechanical Systems, ETH Zurich, Zurich, Switzerland.,Swiss Federal Laboratories for Materials Science and Technology, EMPA, Dübendorf, Switzerland
| | - Edoardo Mazza
- Institute of Mechanical Systems, ETH Zurich, Zurich, Switzerland.,Swiss Federal Laboratories for Materials Science and Technology, EMPA, Dübendorf, Switzerland
| | - Jan Deprest
- Centre for Surgical Technologies, Biomedical Sciences Group, KU Leuven, Leuven, Belgium
| | - Jan Paul Roovers
- Department of Obstetrics and Gynaecology, Center for Reproductive Medicine (AMC), Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands
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7
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Long J, Lee CL, Yang SW, Lee JY, Lee JG, Song KH, Lim JS, Park JM, Na YG, Gil G, Shin JH. Transobturator four-arms mesh in the surgical management of cystocele: a long-term follow-up. J Exerc Rehabil 2021; 17:59-65. [PMID: 33728290 PMCID: PMC7939986 DOI: 10.12965/jer.2142098.049] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/02/2021] [Accepted: 02/03/2021] [Indexed: 12/15/2022] Open
Abstract
We studied the long-term efficacy and safety of cystocele operation by polypropylene mesh. A total of 198 women with stage ≥2 cystocele who had anterior vaginal wall repair with transobturator four-arm polypropylene mesh during 2003 to 2015 were evaluated. Outcomes including clinical characteristics and complications were reviewed by extracting patient data from electronic medical records. In addition, telephone interviews were conducted using a validated questionnaire along with physical examination. The follow-up period was 9.3±0.3 years. The cystocele stage in patients was significantly decreased post-operation compared to that preoperation. The anatomical cure rate for cystocele was 93.4%, and that for stress urinary incontinence was 95%. Comparing the three questionnaires indicated overall average score was improved significantly, except for Female Sexual Function Index Assessment. Early complications were either resolved spontaneously or controlled medically in four cases of hematoma or abscess, three cases of vaginal infection and urinary tract infection, and four cases of difficult micturition. In late complications, four cases of pain were managed, five cases of recurrence were observed and two cases of mesh exposure were treated with ointment and local excision. Transobturator four-arms mesh is an effective and safe method for cystocele repair with low rate of recurrence and complications. We suggest that the use of transobturator four-arm mesh is a still good choice for the old patients with cystocele who are not suitable for general anesthesia and reside in areas where laparoscopy and robots are not available.
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Affiliation(s)
- Jin Long
- Department of Urology, College of Medicine, Chungnam National University, Daejeon, Korea
| | - Chung Lyul Lee
- Department of Urology, College of Medicine, Chungnam National University, Daejeon, Korea
| | - Seung Woo Yang
- Department of Urology, College of Medicine, Chungnam National University, Daejeon, Korea
| | - Ji Yong Lee
- Department of Urology, College of Medicine, Chungnam National University, Daejeon, Korea
| | - Jae Geun Lee
- Department of Urology, College of Medicine, Chungnam National University, Daejeon, Korea
| | - Ki Hak Song
- Department of Urology, College of Medicine, Chungnam National University, Daejeon, Korea
| | - Jae Sung Lim
- Department of Urology, College of Medicine, Chungnam National University, Daejeon, Korea
| | - Jong Mok Park
- Department of Urology, College of Medicine, Chungnam National University, Daejeon, Korea
| | - Yong Gil Na
- Department of Urology, College of Medicine, Chungnam National University, Daejeon, Korea
| | - Geon Gil
- Well Urogoly Clinic, Daejeon, Korea
| | - Ju Hyun Shin
- Department of Urology, College of Medicine, Chungnam National University, Daejeon, Korea
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Aubert M, Mege D, Le Huu Nho R, Meurette G, Sielezneff I. Surgical management of the rectocele - An update. J Visc Surg 2021; 158:145-157. [PMID: 33495108 DOI: 10.1016/j.jviscsurg.2020.10.001] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/16/2022]
Abstract
Rectocele is defined as a hernia of the rectum with protrusion of the anterior rectal wall through the posterior wall of the vagina. This condition occurs commonly, with an estimated prevalence of 30-50% of women over age 50. The symptomatology that leads to consultation is variable but consists predominantly of anorectal and/or gynecological complaints such as dyschezia, requiring digital disimpaction maneuvers, pelvic heaviness, anal incontinence, or dyspareunia. Rectocele may be isolated or associated with other disorders of pelvic stasis involving cystocele and uterine prolapse. Complementary exams (dynamic imaging and anorectal manometry) are essential before deciding on the surgical management of this condition. The indications for surgical management of rectocele are based on the intensity of symptoms and the resulting deterioration in quality of life, and surgery should be discussed after failure of medical treatment. Different approaches are possible, although there is currently no real consensus in the literature. The initial approach depends on the type of rectocele: if it involves the low or mid rectum or is isolated, an approach from below (transanal, transperineal, or transvaginal approach) can be proposed, while, in the presence of a high rectocele and/or associated with various disorders of pelvic stasis, transabdominal rectopexy is more suitable.
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Affiliation(s)
- M Aubert
- Department of digestive and general surgery, Aix Marseille university, Timone hospital, Assistance publique-Hopitaux de Marseille (AP-HM), 13354 Marseille, France
| | - D Mege
- Department of digestive and general surgery, Aix Marseille university, Timone hospital, Assistance publique-Hopitaux de Marseille (AP-HM), 13354 Marseille, France.
| | - R Le Huu Nho
- Department of digestive and general surgery, Aix Marseille university, Timone hospital, Assistance publique-Hopitaux de Marseille (AP-HM), 13354 Marseille, France
| | - G Meurette
- Department of cancer, digestive and endocrine surgery, Nantes university hospital, 44093 Nantes, France
| | - I Sielezneff
- Department of digestive and general surgery, Aix Marseille university, Timone hospital, Assistance publique-Hopitaux de Marseille (AP-HM), 13354 Marseille, France
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Cystocele Repair by a Modified Surgical Technique of Bilateral Pubococcygeus Plication: Long-Term Surgical and Functional Results. J Clin Med 2020; 9:jcm9103318. [PMID: 33081090 PMCID: PMC7602712 DOI: 10.3390/jcm9103318] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/23/2020] [Revised: 09/30/2020] [Accepted: 10/15/2020] [Indexed: 12/23/2022] Open
Abstract
Here we describe our modified surgical technique of bilateral pubococcygeus plication (BPCP) for cystocele repair and assess its safety and long-term outcomes. This is a prospective study of 147 consecutive women who underwent BPCP for cystocele between January 2010 to January 2018. Inclusion criteria was naïve women with symptomatic cystocele ≥ POP-Q 2nd stage. Exclusion criteria: stress urinary incontinence (SUI), urgency urinary incontinence, other associated vaginal wall prolapses ≥ stage 2, neurological diseases, previous SUI surgeries, and previous radiation/surgery of the pelvic area. BPCP was performed by obtaining the medialization of the pubococcygeus muscle fibers of the right and left sides. Statistical analysis was performed. Objective cure was POP-Q < 2nd stage. Subjective cure and functional outcomes were evaluated by validated questionnaires. Patient’s satisfaction was assessed by a Likert-type scale. Mean operative time was 64 min. At a mean follow-up of 82.4 months, objective and subjective success rates were 89.8% and 92.2% respectively. De novo urgency was 3.2%. Surgery did not alter sexual function. Complications occurred in 4.8%, and were: wrong dissection plane, hematoma, and pain lasting between 24–72 h. BPCP for correction of cystocele is safe and effective, with limited risk of complication and good long-term results.
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10
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Joint Report on Terminology for Surgical Procedures to Treat Pelvic Organ Prolapse. Female Pelvic Med Reconstr Surg 2020; 26:173-201. [PMID: 32079837 DOI: 10.1097/spv.0000000000000846] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/15/2023]
Abstract
Surgeries for pelvic organ prolapse (POP) are common, but standardization of surgical terms is needed to improve the quality of investigation and clinical care around these procedures. The American Urogynecologic Society and the International Urogynecologic Association convened a joint writing group consisting of 5 designees from each society to standardize terminology around common surgical terms in POP repair including the following: sacrocolpopexy (including sacral colpoperineopexy), sacrocervicopexy, uterosacral ligament suspension, sacrospinous ligament fixation, iliococcygeus fixation, uterine preservation prolapse procedures or hysteropexy (including sacrohysteropexy, uterosacral hysteropexy, sacrospinous hysteropexy, anterior abdominal wall hysteropexy, Manchester procedure), anterior prolapse procedures (including anterior vaginal repair, anterior vaginal repair with graft, and paravaginal repair), posterior prolapse procedures (including posterior vaginal repair, posterior vaginal repair with graft, levator plication, and perineal repair), and obliterative prolapse repairs (including colpocleisis with hysterectomy, colpocleisis without hysterectomy, and colpocleisis of the vaginal vault). Each of these terms is clearly defined in this document including the required steps of the procedure, surgical variations, and recommendations for procedural terminology.
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Joint report on terminology for surgical procedures to treat pelvic organ prolapse. Int Urogynecol J 2020; 31:429-463. [DOI: 10.1007/s00192-020-04236-1] [Citation(s) in RCA: 16] [Impact Index Per Article: 3.2] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/24/2022]
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Lourenço TRM, Pergialiotis V, Durnea CM, Elfituri A, Haddad JM, Betschart C, Falconi G, Nygaard CC, Bergstrom L, Pattel M, Doumouchtsis SK. A systematic review of reported outcomes and outcome measures in randomized trials evaluating surgical interventions for posterior vaginal prolapse to aid development of a core outcome set. Int J Gynaecol Obstet 2020; 148:271-281. [PMID: 31814121 DOI: 10.1002/ijgo.13079] [Citation(s) in RCA: 13] [Impact Index Per Article: 2.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Revised: 05/05/2019] [Accepted: 12/06/2019] [Indexed: 12/12/2022]
Abstract
BACKGROUND Recent systematic reviews have demonstrated wide variations on outcome measure selection and outcome reporting in trials on surgical treatments for anterior, apical and mesh prolapse surgery. A systematic review of reported outcomes and outcome measures in posterior compartment vaginal prolapse interventions is highly warranted in the process of developing core outcome sets. OBJECTIVE To evaluate outcome and outcome measures reporting in posterior prolapse surgical trials. SEARCH STRATEGY We searched MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials (CENTRAL). SELECTION CRITERIA Randomized trials evaluating the efficacy and safety of different surgical interventions for posterior compartment vaginal prolapse. DATA COLLECTION AND ANALYSIS Two researchers independently assessed studies for inclusion, evaluated methodological quality, and extracted relevant data. Methodological quality, outcome reporting quality and publication characteristics were evaluated. MAIN RESULTS Twenty-seven interventional and four follow-up trials were included. Seventeen studies enrolled patients with posterior compartment surgery as the sole procedure and 14 with multicompartment procedures. Eighty-three reported outcomes and 45 outcome measures were identified. The most frequently reported outcomes were blood loss (20 studies, 74%), pain (18 studies, 66%) and infection (16 studies, 59%). CONCLUSIONS Wide variations in reported outcomes and outcome measures were found. Until a core outcome set is established, we propose an interim core outcome set that could include the three most commonly reported outcomes of the following domains: hospitalization; intraoperative, postoperative urinary, gastrointestinal, vaginal and sexual outcomes; clinical effectiveness. PROSPERO CRD42017062456.
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Affiliation(s)
- Thais R M Lourenço
- Department of Urogynecology, Clinical Hospital of the University of São Paulo School of Medicine, São Paulo University, São Paulo, Brazil
| | - Vasilis Pergialiotis
- Laboratory of Experimental Surgery and Surgical Research "N.S. Christeas", Athens University Medical School, Athens, Greece
| | - Constantin M Durnea
- Department of Obstetrics and Gynecology, Epsom and St Helier University Hospitals NHS Trust, London, UK.,Northwick Park Hospital, London North West University Healthcare NHS Trust, London, UK
| | - Abdullatif Elfituri
- Department of Obstetrics and Gynecology, Epsom and St Helier University Hospitals NHS Trust, London, UK
| | - Jorge M Haddad
- Department of Urogynecology, Clinical Hospital of the University of São Paulo School of Medicine, São Paulo University, São Paulo, Brazil
| | - Cornelia Betschart
- Department of Gynecology, University Hospital of Zurich, Zurich, Switzerland
| | - Gabriele Falconi
- Department of Obstetrics and Gynecology, San Bortolo Hospital, Vicenza, Italy
| | - Christiana C Nygaard
- Department of Obstetrics and Gynecology, Epsom and St Helier University Hospitals NHS Trust, London, UK.,Department of Obstetrics and Gynecology, Hospital São Lucas, Pontifical Catholic University of Rio Grande do Sul, Rio Grande do Sul, Brazil
| | | | | | - Stergios K Doumouchtsis
- Laboratory of Experimental Surgery and Surgical Research "N.S. Christeas", Athens University Medical School, Athens, Greece.,Department of Obstetrics and Gynecology, Epsom and St Helier University Hospitals NHS Trust, London, UK.,St George's University of London, London, UK
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An update of a former
FIGO
Working Group Report on Management of Posterior Compartment Prolapse. Int J Gynaecol Obstet 2019; 148:135-144. [DOI: 10.1002/ijgo.13006] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/26/2018] [Revised: 09/04/2019] [Accepted: 10/17/2019] [Indexed: 12/12/2022]
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Palmerola R, Rosenblum N. Prolapse Repair Using Non-synthetic Material: What is the Current Standard? Curr Urol Rep 2019; 20:70. [PMID: 31612341 DOI: 10.1007/s11934-019-0939-8] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/25/2022]
Abstract
PURPOSE OF REVIEW Due to recent concerns over the use of synthetic mesh in pelvic floor reconstructive surgery, there has been a renewed interest in the utilization of non-synthetic repairs for pelvic organ prolapse. The purpose of this review is to review the current literature regarding pelvic organ prolapse repairs performed without the utilization of synthetic mesh. RECENT FINDINGS Native tissue repairs provide a durable surgical option for pelvic organ prolapse. Based on recent findings of recently performed randomized clinical trials with long-term follow-up, transvaginal native tissue repair continues to play a role in the management of pelvic organ prolapse without the added risk associated with synthetic mesh. In 2019, the FDA called for manufacturers of synthetic mesh for transvaginal mesh to stop selling and distributing their products in the USA. Native tissue and non-synthetic pelvic organ prolapse repairs provide an efficacious alternative without the added risk inherent to the utilization of transvaginal mesh. A recent, multicenter, randomized clinical trial demonstrated no clear advantage to the utilization of synthetic mesh. Furthermore, transvaginal native tissue repairs have demonstrated good long-term efficacy, particularly when anatomic success is not the sole metric used to define surgical success.
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Affiliation(s)
- Ricardo Palmerola
- Departments of Urology and Obstetrics & Gynecology, New York University School of Medicine, 222 East 41st Street, 11th Floor, New York, NY, 10017, USA.
| | - Nirit Rosenblum
- Departments of Urology and Obstetrics & Gynecology, New York University School of Medicine, 222 East 41st Street, 11th Floor, New York, NY, 10017, USA
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Sohlberg EM, Dallas KB, Weeks BT, Elliott CS, Rogo-Gupta L. Reoperation rates for pelvic organ prolapse repairs with biologic and synthetic grafts in a large population-based cohort. Int Urogynecol J 2019; 31:291-301. [DOI: 10.1007/s00192-019-04035-3] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/15/2019] [Accepted: 06/17/2019] [Indexed: 01/01/2023]
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Steures P, Milani AL, van Rumpt-van de Geest DA, Kluivers KB, Withagen MIJ. Partially absorbable mesh or native tissue repair for pelvic organ prolapse: a randomized controlled trial. Int Urogynecol J 2019; 30:565-573. [PMID: 30159720 PMCID: PMC6450832 DOI: 10.1007/s00192-018-3757-5] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/22/2018] [Accepted: 07/31/2018] [Indexed: 01/01/2023]
Abstract
INTRODUCTION AND HYPOTHESIS The objective was to compare medium-term efficacy and safety of a partially absorbable mesh kit and native tissue repair in pelvic organ prolapse (POP). MATERIALS AND METHODS Women with primary POP stage ≥ II were randomized to transvaginal trocar-guided partially absorbable mesh (81 women) or native tissue repair (82 women). Primary outcome was overall anatomical success (POP < stage II) at 24 months. Secondary outcomes were composite success, global improvement, and adverse events. RESULTS Sixty-nine (85%) of the women allocated to partially absorbable mesh underwent mesh surgery; 8 (10%) crossed over to native tissue repair and 4 women (5%) withdrew from the study. Eighty (98%) of the women allocated to native tissue repair underwent the assigned treatment and 2 (2%) withdrew. Twenty-four months later, 140 surgically treated women (89%) demonstrated an overall anatomical success of 39%; 45% (32 out of 71 women) for mesh, and 32% (22 out of 69) for native tissue repair (RR 1.4, 95% CI 0.92 to 2.2). Composite success was 88 and 73% respectively (RR: 1.1, 95% CI 0.93 to 1.4). There was global improvement in 86% (48 out of 56 women) in the mesh group and in 77% (47 out of 60 women) in the native tissue group (RR: 1.1, 95% CI 0.92 to 1.3). Four women were diagnosed with mesh exposure at 2 years (6%). CONCLUSION At 24 months, no significant anatomical or composite benefit of partially absorbable mesh over native tissue repair could be demonstrated in women who had been surgically treated for primary POP.
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Affiliation(s)
- Pieternel Steures
- Department of Obstetrics and Gynaecology, Reinier de Graaf Gasthuis, Delft, The Netherlands.
- Department of Obstetrics and Gynaecology, Jeroen Bosch Ziekenhuis, Postbus 90153, 5200 ME, Den Bosch, The Netherlands.
| | - Alfredo L Milani
- Department of Obstetrics and Gynaecology, Reinier de Graaf Gasthuis, Delft, The Netherlands
| | | | - Kirsten B Kluivers
- Department of Obstetrics and Gynaecology, Radboud University Medical Center, Nijmegen, The Netherlands.
| | - Mariëlla I J Withagen
- Department of Obstetrics and Gynaecology, University Medical Center Utrecht, Utrecht, The Netherlands
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Chung SH, Kim WB. Various Approaches and Treatments for Pelvic Organ Prolapse in Women. J Menopausal Med 2018; 24:155-162. [PMID: 30671407 PMCID: PMC6336571 DOI: 10.6118/jmm.2018.24.3.155] [Citation(s) in RCA: 16] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/09/2018] [Revised: 10/01/2018] [Accepted: 11/02/2018] [Indexed: 11/25/2022] Open
Abstract
Pelvic organ prolapse (POP) is bulging of one or more of the pelvic organs into the vagina and triggered by multiple causes. It is a very common disorder, especially among older women. POP is characterized by protrusion of the presentation part visible by the naked eye, and problems with urination or bowel movements. POP can be diagnosed based on the onset of symptoms and a pelvic exam, and management options include medical and surgical treatment. Although medical treatment cannot correct the abnormal herniation of the pelvic structures, this can help alleviate symptoms. One of the disadvantages of surgical interventions is recurrence, and advances in surgical techniques have decreased recurrence rates of POP. Therefore, author will explain the gynecology and urology approach and treatment.
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Affiliation(s)
- Soo-Ho Chung
- Department of Obstetrics and Gynecology, Soonchunhyang University College of Medicine, Bucheon, Korea
| | - Woong Bin Kim
- Department of Urology, Soonchunhyang University College of Medicine, Bucheon, Korea
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Abstract
Posterior compartment vaginal prolapse can be approached with multiple surgical techniques, including transvaginally, transperineally, and transanally, repaired with either native tissue or with the addition of an augment. Augment material for posterior compartment prolapse includes biologic graft (dermal, porcine submucosal), absorbable mesh (Vicryl polyglactin), or nonabsorbable synthetic mesh (polypropylene). Anatomic success rates for posterior compartment repair with augment has ranged from 54% to 92%. Augmented posterior compartment repair has not been shown to have superior outcome to native tissue repair. The focus of this article is on the transvaginal approach comparing native tissue repair with graft or mesh augmented repair.
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Transperineal rectocele repair with biomesh: updating of a tertiary refer center prospective study. Int J Colorectal Dis 2018; 33:1583-1588. [PMID: 29675591 DOI: 10.1007/s00384-018-3054-2] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 04/09/2018] [Indexed: 02/04/2023]
Abstract
PURPOSE Symptomatic rectocele results in obstructed defecation and constipation. Surgical repair may provide symptomatic relief. A variety of surgical procedures have been used in the rectocele repair to enhance anatomical and functional results and to improve long-term outcomes. METHODS In this prospective study, we treated 25 selected women suffering from simple symptomatic rectocele with transperineal repair using porcine dermal acellular collagen matrix Biomesh (Permacol®). Watson score and SF-36 questionnaire were used to evaluate postoperative outcomes and quality of life. RESULTS Follow-up ranged from 12 to 24 months, the mean total Watson score was significantly lower than the preoperative score (P < 0.001), and every patient has improved functional outcomes. There were no major intraoperative or postoperative complications. Two cases of urinary infection and 4 patients delayed wound healing were reported. Those patients who were sexually active prior to surgery have not experienced problems with sexual function or dyspareunia. CONCLUSIONS Despite lack of comparative study in literature, rectocele repair with Permacol® by the transperineal approach seems an effective and safe procedure that avoids some of the complications associated with synthetic mesh use.
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Durnea CM, Pergialiotis V, Duffy JMN, Bergstrom L, Elfituri A, Doumouchtsis SK. A systematic review of outcome and outcome-measure reporting in randomised trials evaluating surgical interventions for anterior-compartment vaginal prolapse: a call to action to develop a core outcome set. Int Urogynecol J 2018; 29:1727-1745. [PMID: 30350116 PMCID: PMC6244754 DOI: 10.1007/s00192-018-3781-5] [Citation(s) in RCA: 29] [Impact Index Per Article: 4.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/07/2018] [Accepted: 07/12/2018] [Indexed: 01/02/2023]
Abstract
Introduction We assessed outcome and outcome-measure reporting in randomised controlled trials evaluating surgical interventions for anterior-compartment vaginal prolapse and explored the relationships between outcome reporting quality with journal impact factor, year of publication, and methodological quality. Methods We searched the bibliographical databases from inception to October 2017. Two researchers independently selected studies and assessed study characteristics, methodological quality (Jadad criteria; range 1–5), and outcome reporting quality Management of Otitis Media with Effusion in Cleft Palate (MOMENT) criteria; range 1–6], and extracted relevant data. We used a multivariate linear regression to assess associations between outcome reporting quality and other variables. Results Eighty publications reporting data from 10,924 participants were included. Seventeen different surgical interventions were evaluated. One hundred different outcomes and 112 outcome measures were reported. Outcomes were inconsistently reported across trials; for example, 43 trials reported anatomical treatment success rates (12 outcome measures), 25 trials reported quality of life (15 outcome measures) and eight trials reported postoperative pain (seven outcome measures). Multivariate linear regression demonstrated a relationship between outcome reporting quality with methodological quality (β = 0.412; P = 0.018). No relationship was demonstrated between outcome reporting quality with impact factor (β = 0.078; P = 0.306), year of publication (β = 0.149; P = 0.295), study size (β = 0.008; P = 0.961) and commercial funding (β = −0.013; P = 0.918). Conclusions Anterior-compartment vaginal prolapse trials report many different outcomes and outcome measures and often neglect to report important safety outcomes. Developing, disseminating and implementing a core outcome set will help address these issues.
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Affiliation(s)
- Constantin M Durnea
- Department of Obstetrics and Gynaecology, Epsom and St Helier University Hospitals NHS Trust, Rowan House, Dorking Road, Epsom, London, KT18 7EG, UK.,Nortwick Park Hospital, London North West University Healthcare NHS Trust, London, UK
| | - Vasilios Pergialiotis
- Laboratory of Experimental Surgery and Surgical Research N.S. Christeas, Athens University Medical School, Athens, Greece
| | - James M N Duffy
- Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.,Balliol College, University of Oxford, Oxford, UK
| | | | - Abdullatif Elfituri
- Department of Obstetrics and Gynaecology, Epsom and St Helier University Hospitals NHS Trust, Rowan House, Dorking Road, Epsom, London, KT18 7EG, UK
| | - Stergios K Doumouchtsis
- Department of Obstetrics and Gynaecology, Epsom and St Helier University Hospitals NHS Trust, Rowan House, Dorking Road, Epsom, London, KT18 7EG, UK. .,Laboratory of Experimental Surgery and Surgical Research N.S. Christeas, Athens University Medical School, Athens, Greece. .,St George's University of London, London, UK.
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Halpern-Elenskaia K, Umek W, Bodner-Adler B, Hanzal E. Anterior colporrhaphy: a standard operation? Systematic review of the technical aspects of a common procedure in randomized controlled trials. Int Urogynecol J 2018; 29:781-788. [PMID: 29214325 PMCID: PMC5948274 DOI: 10.1007/s00192-017-3510-5] [Citation(s) in RCA: 15] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/23/2017] [Accepted: 08/29/2017] [Indexed: 01/24/2023]
Abstract
INTRODUCTION Anterior colporrhaphy (AC) is considered a standard procedure and is performed all over the world. However, not a single step of the procedure has ever been truly standardized and the rates of failure show a wide range in the literature from 0% up to 92%. The aim of this systematic review was to evaluate the differences in technique and procedure worldwide. METHODS We performed a systematic literature search up to March 2016 using the MeSH terms "(anterior AND (colporrhaph* or colporhaph* or repair* or cystocel*)" using Preferred Reporting Items for Sytematic Reviews and Meta-Analyses (PRISMA). Only randomized controlled trials (RCT) were included in the systematic review. A 14-point checklist was used to assess the quality of surgery undertaken in each RCT. RESULTS Forty RCTs from all over the world were included in the review. The indication for AC was urinary incontinence and/or pelvic organ prolapse. A detailed description of colporrhaphy was not provided even in the well-conducted RCTs. The review showed differences in each step of the procedure, in perioperative care, in anesthesia and in surgeon' experience. CONCLUSION Our results highlight the problems concerning AC with the great range in postoperative outcomes. There is diversity in the anatomical structures used in the repair, in perioperative care and in the procedure itself.
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Affiliation(s)
- Ksenia Halpern-Elenskaia
- Division of General Gynecology and Gynecologic Oncology, Department of Obstetrics and Gynecology, Medical University Vienna, Waehringer Guertel 18, 1090, Vienna, Austria.
| | - Wolfgang Umek
- Division of General Gynecology and Gynecologic Oncology, Department of Obstetrics and Gynecology, Medical University Vienna, Waehringer Guertel 18, 1090, Vienna, Austria
| | - Barbara Bodner-Adler
- Division of General Gynecology and Gynecologic Oncology, Department of Obstetrics and Gynecology, Medical University Vienna, Waehringer Guertel 18, 1090, Vienna, Austria
| | - Engelbert Hanzal
- Division of General Gynecology and Gynecologic Oncology, Department of Obstetrics and Gynecology, Medical University Vienna, Waehringer Guertel 18, 1090, Vienna, Austria
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Mowat A, Maher D, Baessler K, Christmann‐Schmid C, Haya N, Maher C. Surgery for women with posterior compartment prolapse. Cochrane Database Syst Rev 2018; 3:CD012975. [PMID: 29502352 PMCID: PMC6494287 DOI: 10.1002/14651858.cd012975] [Citation(s) in RCA: 32] [Impact Index Per Article: 4.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/30/2023]
Abstract
BACKGROUND Posterior vaginal wall prolapse (also known as 'posterior compartment prolapse') can cause a sensation of bulge in the vagina along with symptoms of obstructed defecation and sexual dysfunction. Interventions for prevention and conservative management include lifestyle measures, pelvic floor muscle training, and pessary use. We conducted this review to assess the surgical management of posterior vaginal wall prolapse. OBJECTIVES To evaluate the safety and effectiveness of any surgical intervention compared with another surgical intervention for management of posterior vaginal wall prolapse. SEARCH METHODS We searched the Cochrane Incontinence Group Specialised Register of controlled trials, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) (searched April 2017). We also searched the reference lists of relevant articles, and we contacted researchers in the field. SELECTION CRITERIA We included randomised controlled trials (RCTs) comparing different types of surgery for posterior vaginal wall prolapse. DATA COLLECTION AND ANALYSIS We used Cochrane methods. Our primary outcomes were subjective awareness of prolapse, repeat surgery for any prolapse, and objectively determined recurrent posterior wall prolapse. MAIN RESULTS We identified 10 RCTs evaluating 1099 women. Evidence quality ranged from very low to moderate. The main limitations of evidence quality were risk of bias (associated mainly with performance, detection, and attrition biases) and imprecision (associated with small overall sample sizes and low event rates).Transanal repair versus transvaginal repair (four RCTs; n = 191; six months' to four years' follow-up)Awareness of prolapse is probably more common after the transanal approach (risk ratio (RR) 2.78, 95% confidence interval (CI) 1.00 to 7.70; 2 RCTs; n = 87; I2 = 0%; low-quality evidence). If 10% of women are aware of prolapse after transvaginal repair, between 10% and 79% are likely to be aware after transanal repair.Repeat surgery for any prolapse: Evidence is insufficient to show whether there were any differences between groups (RR 2.42, 95% CI 0.75 to 7.88; 1 RCT; n = 57; low-quality evidence).Recurrent posterior vaginal wall prolapse is probably more likely after transanal repair (RR 4.12, 95% CI 1.56 to 10.88; 2 RCTs; n = 87; I2 = 35%; moderate-quality evidence). If 10% of women have recurrent prolapse on examination after transvaginal repair, between 16% and 100% are likely to have recurrent prolapse after transanal repair.Postoperative obstructed defecation is probably more likely with transanal repair (RR 1.67, 95% CI 1.00 to 2.79; 3 RCTs; n = 113; I2 = 10%; low-quality evidence).Postoperative dyspareunia: Evidence is insufficient to show whether there were any differences between groups (RR 0.32, 95% CI 0.09 to 1.15; 2 RCTs; n = 80; I2 = 5%; moderate-quality evidence).Postoperative complications: Trials have provided no conclusive evidence of any differences between groups (RR 3.57, 95% CI 0.94 to 13.54; 3 RCTs; n = 135; I2 = 37%; low-quality evidence). If 2% of women have complications after transvaginal repair, then between 2% and 21% are likely to have complications after transanal repair.Evidence shows no clear differences between groups in operating time (in minutes) (mean difference (MD) 1.49, 95% CI -11.83 to 8.84; 3 RCTs; n = 137; I2 = 90%; very low-quality evidence).Biological graft versus native tissue repairEvidence is insufficient to show whether there were any differences between groups in rates of awareness of prolapse (RR 1.09, 95% CI 0.45 to 2.62; 2 RCTs; n = 181; I2 = 13%; moderate-quality evidence) or repeat surgery for any prolapse (RR 0.60, 95% CI 0.18 to 1.97; 2 RCTs; n = 271; I2 = 0%; moderate-quality evidence). Trials have provided no conclusive evidence of a difference in rates of recurrent posterior vaginal wall prolapse (RR 0.55, 95% CI 0.30 to 1.01; 3 RCTs; n = 377; I2 = 6%; moderate-quality evidence); if 13% of women have recurrent prolapse on examination after native tissue repair, between 4% and 13% are likely to have recurrent prolapse after biological graft. Evidence is insufficient to show whether there were any differences between groups in rates of postoperative obstructed defecation (RR 0.96, 95% CI 0.50 to 1.86; 2 RCTs; n = 172; I2 = 42%; moderate-quality evidence) or postoperative dyspareunia (RR 1.27, 95% CI 0.26 to 6.25; 2 RCTs; n = 152; I2 = 74%; low-quality evidence). Postoperative complications were more common with biological repair (RR 1.82, 95% CI 1.22 to 2.72; 3 RCTs; n = 448; I2 = 0%; low-quality evidence).Other comparisonsSingle RCTs compared site-specific vaginal repair versus midline fascial plication (n = 74), absorbable graft versus native tissue repair (n = 132), synthetic graft versus native tissue repair (n = 191), and levator ani plication versus midline fascial plication (n = 52). Data were scanty, and evidence was insufficient to show any conclusions about the relative effectiveness or safety of any of these interventions. The mesh exposure rate in the synthetic group compared with the native tissue group was 7%. AUTHORS' CONCLUSIONS Transvaginal repair may be more effective than transanal repair for posterior wall prolapse in preventing recurrence of prolapse, in the light of both objective and subjective measures. However, data on adverse effects were scanty. Evidence was insufficient to permit any conclusions about the relative effectiveness or safety of other types of surgery. Evidence does not support the utilisation of any mesh or graft materials at the time of posterior vaginal repair. Withdrawal of some commercial transvaginal mesh kits from the market may limit the generalisability of our findings.
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Affiliation(s)
- Alex Mowat
- Royal Brisbane and Women's HospitalBrisbaneAustralia
| | - Declan Maher
- Bond University14 University DriveRobinaQueenslandAustralia4226
| | - Kaven Baessler
- Pelvic Floor Centre ChariteUrogynaecology DepartmentHindenburgdamm 30BerlinGermany12200
| | | | - Nir Haya
- Lady Davis Carmel Medical Center, and the Ruth and Bruce Rappaport School of Medicine, Technion‐Israel Institute of TechnologyDepartment of Obstetrics and Gynaecology6 Michal StHaifaIsrael34364
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Glazener C, Breeman S, Elders A, Hemming C, Cooper K, Freeman R, Smith A, Hagen S, Montgomery I, Kilonzo M, Boyers D, McDonald A, McPherson G, MacLennan G, Norrie J. Clinical effectiveness and cost-effectiveness of surgical options for the management of anterior and/or posterior vaginal wall prolapse: two randomised controlled trials within a comprehensive cohort study - results from the PROSPECT Study. Health Technol Assess 2018; 20:1-452. [PMID: 28052810 DOI: 10.3310/hta20950] [Citation(s) in RCA: 29] [Impact Index Per Article: 4.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/22/2022] Open
Abstract
BACKGROUND The use of mesh in prolapse surgery is controversial, leading to a number of enquiries into its safety and efficacy. OBJECTIVE To compare synthetic non-absorbable mesh inlay, biological graft and mesh kit with a standard repair in terms of clinical effectiveness, adverse effects, quality of life (QoL), costs and cost-effectiveness. DESIGN Two randomised controlled trials within a comprehensive cohort (CC) study. Allocation was by a remote web-based randomisation system in a 1 :1 : 1 ratio (Primary trial) or 1 : 1 : 2 ratio (Secondary trial), and was minimised on age, type of prolapse repair planned, need for a concomitant continence procedure, need for a concomitant upper vaginal prolapse procedure and surgeon. Participants and outcome assessors were blinded to randomisation; participants were unblinded if they requested the information. Surgeons were not blinded to allocated procedure. SETTING Thirty-five UK hospitals. PARTICIPANTS Primary study: 2474 women in the analysis (including 1348 randomised) having primary anterior or posterior prolapse surgery. Secondary study: 398 in the analysis (including 154 randomised) having repeat anterior or posterior prolapse surgery. CC3: 215 women having either uterine or vault prolapse repair. INTERVENTIONS Anterior or posterior repair alone, or with mesh inlay, biological graft or mesh kit. MAIN OUTCOME MEASURES Prolapse symptoms [Pelvic Organ Prolapse Symptom Score (POP-SS)]; prolapse-specific QoL; cost-effectiveness [incremental cost per quality-adjusted life-year (QALY)]. RESULTS Primary trials: adjusting for baseline and minimisation covariates, mean POP-SS was similar for each comparison {standard 5.4 [standard deviation (SD) 5.5] vs. mesh 5.5 (SD 5.1), mean difference (MD) 0.00, 95% confidence interval (CI) -0.70 to 0.71; standard 5.5 (SD 5.6) vs. graft 5.6 (SD 5.6), MD -0.15, 95% CI -0.93 to 0.63}. Serious non-mesh adverse effects rates were similar between the groups in year 1 [standard 7.2% vs. mesh 7.8%, risk ratio (RR) 1.08, 95% CI 0.68 to 1.72; standard 6.3% vs. graft 9.8%, RR 1.57, 95% CI 0.95 to 2.59]. There were no statistically significant differences between groups in any other outcome measure. The cumulative mesh complication rates over 2 years were 2 of 430 (0.5%) for standard repair (trial 1), 46 of 435 (10.6%) for mesh inlay and 2 of 368 (0.5%) for biological graft. The CC findings were comparable. Incremental costs were £363 (95% CI -£32 to £758) and £565 (95% CI £180 to £950) for mesh and graft vs. standard, respectively. Incremental QALYs were 0.071 (95% CI -0.004 to 0.145) and 0.039 (95% CI -0.041 to 0.120) for mesh and graft vs. standard, respectively. A Markov decision model extrapolating trial results over 5 years showed standard repair had the highest probability of cost-effectiveness, but results were surrounded by considerable uncertainty. Secondary trials: there were no statistically significant differences between the randomised groups in any outcome measure, but the sample size was too small to be conclusive. The cumulative mesh complication rates over 2 years were 7 of 52 (13.5%) for mesh inlay and 4 of 46 (8.7%) for mesh kit, with no mesh exposures for standard repair. CONCLUSIONS In women who were having primary repairs, there was evidence of no benefit from the use of mesh inlay or biological graft compared with standard repair in terms of efficacy, QoL or adverse effects (other than mesh complications) in the short term. The Secondary trials were too small to provide conclusive results. LIMITATIONS Women in the Primary trials included some with a previous repair in another compartment. Follow-up is vital to identify any long-term potential benefits and serious adverse effects. FUTURE WORK Long-term follow-up to at least 6 years after surgery is ongoing to identify recurrence rates, need for further prolapse surgery, adverse effects and cost-effectiveness. TRIAI REGISTRATION Current Controlled Trials ISRCTN60695184. FUNDING This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 95. See the NIHR Journals Library website for further project information.
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Affiliation(s)
- Cathryn Glazener
- Health Services Research Unit, University of Aberdeen, Aberdeen, UK
| | - Suzanne Breeman
- Health Services Research Unit, University of Aberdeen, Aberdeen, UK
| | - Andrew Elders
- Nursing, Midwifery and Allied Health Professionals Research Unit, Glasgow Caledonian University, Glasgow, UK
| | | | | | | | | | - Suzanne Hagen
- Nursing, Midwifery and Allied Health Professionals Research Unit, Glasgow Caledonian University, Glasgow, UK
| | | | - Mary Kilonzo
- Health Economics Research Unit, University of Aberdeen, Aberdeen, UK
| | - Dwayne Boyers
- Health Services Research Unit, University of Aberdeen, Aberdeen, UK.,Health Economics Research Unit, University of Aberdeen, Aberdeen, UK
| | - Alison McDonald
- Health Services Research Unit, University of Aberdeen, Aberdeen, UK
| | - Gladys McPherson
- Health Services Research Unit, University of Aberdeen, Aberdeen, UK
| | - Graeme MacLennan
- Health Services Research Unit, University of Aberdeen, Aberdeen, UK
| | - John Norrie
- Health Services Research Unit, University of Aberdeen, Aberdeen, UK
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Anterior Colporrhaphy With and Without Dermal Allograft: A Randomized Control Trial With Long-Term Follow-Up. Female Pelvic Med Reconstr Surg 2018; 25:206-212. [PMID: 29300253 DOI: 10.1097/spv.0000000000000524] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/26/2022]
Abstract
OBJECTIVE The objective of this study was to determine whether anterior colporrhaphy plus insertion of anterior dermal allograft reduces anterior prolapse recurrence at 1 and 7 to 10 years postoperatively compared with anterior colporrhaphy alone. METHODS We present a nonblinded randomized controlled trial with 1- and 7- to 10-year follow-up. Subjects were randomized between 2005 and 2008 to anterior colporrhaphy or ultralateral anterior colporrhaphy plus insertion of a dermal allograft spanning the anterior compartment between the arcus tendineus fascia pelvis on each side. Eligible subjects had anterior prolapse to the hymen or beyond, were bothered by their prolapse, and were planning to undergo surgical correction. Subjects completed a pelvic organ prolapse quantification system (POPQ) examination and Pelvic Floor Distress Inventory (PFDI)/PFDI-20 before surgery; a POPQ, PFDI, and Pelvic Organ Prolapse/Incontinence Sexual Questionnaire at 1 year postoperatively; and a POPQ, PFDI-20, Pelvic Organ Prolapse/Incontinence Sexual Questionnaire, Revised, and Patient-reported Global Impression of Improvement Inventory at 7 to 10 years postoperatively. Our primary outcome was anatomic anterior prolapse recurrence at 1 or 7 to 10 years defined as Aa or Ba greater than or equal to -1. Our secondary outcome was a composite score of anterior prolapse recurrence at 1 or 7 to 10 years defined as anatomic recurrence (Aa or Ba ≥ 0), retreatment for cystocele, or answering yes to PFDI-20 question 3 (subjective report of vaginal bulge). RESULTS A total of 114 subjects were randomized, 70 to anterior colporrhaphy and 44 to anterior colporrhaphy plus dermal allograft. About 92% of subjects underwent concomitant apical suspension, 98% in the graft group and 89% in the nongraft group. Eighty-nine subjects (32 graft [73%], 57 nongraft [81%]) returned for 1-year follow-up. Fifty-three patients (19 graft [48%], 34 nongraft [49%]) returned for 7- to 10-year follow-up. The primary outcome was met by 8 (18%) graft and 22 (31%) nongraft subjects at 1 year postoperatively (P = 0.26) and by 10 (23%) graft and 24 (34%) nongraft subjects at 7 to 10 years postoperatively (P = 0.37). The secondary outcome was met by 8 (18%) graft and 15 (21%) nongraft subjects at 1 year postoperatively (P = 0.74) and by 13 (30%) graft and 21 (30.0%) nongraft subjects at 7 to 10 years postoperatively (P = 0.99). CONCLUSIONS We cannot conclude whether there is a difference in anterior recurrence for anterior colporrhaphy with and without dermal allograft and do not recommend changes in clinical practice based on these results.
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Montera R, Miranda A, Plotti F, Terranova C, Luvero D, Capriglione S, Scaletta G, Zullo MA, Buscarini M, Lopez S, Gatti A, Schirò T, De Cicco Nardone C, Angioli R. Anterior colporrhaphy plus inside-out tension-free vaginal tape for associated stress urinary incontinence and cystocele: 10-year follow up results. Neurourol Urodyn 2017; 37:1144-1151. [PMID: 29058820 DOI: 10.1002/nau.23439] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/23/2017] [Accepted: 09/25/2017] [Indexed: 11/06/2022]
Abstract
AIMS We report the success rate and complications rate of combined ultralateral anterior Colporrhaphy plus Tension-free Vaginal Tape (TVT-O) in a long-term (10 year) follow-up prospective survey. METHODS Patients previously treated for associated stress urinary incontinence (SUI) and cystocele were subjected to annual follow-up for 10 year with a complete urogynecologic evaluation. Furthermore, an urodynamic assessment and a quality of life questionnaire (ICIQ-UI SF) were recorded at the 5th and 10th year of follow up. RESULTS Fifty patients treated between June 2004 and May 2006 were included in the analysis. Five patients did not return to 5-yr follow-up: two patients developed a median tape erosion and three patients withdraw. At 10-yr follow-up two more patients withdraw for a total of seven patients lost to follow-up. After 10 years patients objectively cured from cystocele were 41 (95%) while patients objectively cured from SUI were 39 (91%). At 10th year follow-up 38 patients (89%) result cured from both SUI and cystocele, 3 (7%) patients result cured only from prolapse, 1 (2%) patient only from SUI, and 1 (2%) patient result objectively failed for both SUI and cystocele. The ICIQ-UI SF scores at 10th year follow-up was 6.2 ± 3.7. The late complication rate at 10th year follow-up was 32% (OAB symptoms 20%; Mixed incontinence 2%; Bladder outlet obstruction 0%; Dyspareunia 6%; Chronic pelvic pain 0%; Vaginal tape erosion 4%; Detrusor hyperactivity 0%). CONCLUSIONS The combined procedures shown proved to be an effective and safe procedure to treat concomitant SUI and cystocele.
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Affiliation(s)
- Roberto Montera
- Departments of Obstetrics and Gynecology, Campus Biomedico, University of Rome, Rome, Italy
| | - Andrea Miranda
- Departments of Obstetrics and Gynecology, Campus Biomedico, University of Rome, Rome, Italy
| | - Francesco Plotti
- Departments of Obstetrics and Gynecology, Campus Biomedico, University of Rome, Rome, Italy
| | - Corrado Terranova
- Departments of Obstetrics and Gynecology, Campus Biomedico, University of Rome, Rome, Italy
| | - Daniela Luvero
- Departments of Obstetrics and Gynecology, Campus Biomedico, University of Rome, Rome, Italy
| | - Stella Capriglione
- Departments of Obstetrics and Gynecology, Campus Biomedico, University of Rome, Rome, Italy
| | - Giuseppe Scaletta
- Departments of Obstetrics and Gynecology, Campus Biomedico, University of Rome, Rome, Italy
| | - Marzio A Zullo
- Department of Surgery-Week Surgery, Campus Biomedico, University of Rome, Rome, Italy
| | - Maurizio Buscarini
- Department of Urology, Campus Biomedico, University of Rome, Rome, Italy
| | - Salvatore Lopez
- Departments of Obstetrics and Gynecology, Campus Biomedico, University of Rome, Rome, Italy
| | - Alessandra Gatti
- Departments of Obstetrics and Gynecology, Campus Biomedico, University of Rome, Rome, Italy
| | - Teresa Schirò
- Departments of Obstetrics and Gynecology, Campus Biomedico, University of Rome, Rome, Italy
| | - Carlo De Cicco Nardone
- Departments of Obstetrics and Gynecology, Campus Biomedico, University of Rome, Rome, Italy
| | - Roberto Angioli
- Departments of Obstetrics and Gynecology, Campus Biomedico, University of Rome, Rome, Italy
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Kalkan U, Yoldemir T, Ozyurek ES, Daniilidis A. Native tissue repair versus mesh repair in pelvic organ prolapse surgery. Climacteric 2017; 20:510-517. [DOI: 10.1080/13697137.2017.1366978] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/26/2022]
Affiliation(s)
- U. Kalkan
- Department of Obstetrics and Gynecology, Egemed Hospital, Aydın, Turkey
| | - T. Yoldemir
- Department of Obstetrics and Gynecology, Marmara University Hospital, Istanbul, Turkey
| | - E. S. Ozyurek
- Department of Obstetrics and Gynecology, Bagcilar Research and Training Hospital, Istanbul, Turkey
| | - A. Daniilidis
- 2nd Department of Obstetrics and Gynecology, Hippokratio University Hospital, Thessaloniki, Greece
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Grossi U, Horrocks EJ, Mason J, Knowles CH, Williams AB. Surgery for constipation: systematic review and practice recommendations: Results IV: Recto-vaginal reinforcement procedures. Colorectal Dis 2017; 19 Suppl 3:73-91. [PMID: 28960924 DOI: 10.1111/codi.13781] [Citation(s) in RCA: 18] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/20/2022]
Abstract
AIM To assess the outcomes of recto-vaginal reinforcement procedures in adults with chronic constipation. METHOD Standardised methods and reporting of benefits and harms were used for all CapaCiTY reviews that closely adhered to PRISMA 2016 guidance. Main conclusions were presented as summary evidence statements with a summative Oxford Centre for Evidence-Based Medicine (2009) level. RESULTS Forty-three articles were identified, providing data on outcomes in 3346 patients. Average length of procedures ranged between 20 and 169 min, and length of stay between 1 and 15 days. Complications typically occurred after 7-17% of procedures (range 0-61%). Post-operative bleeding was uncommon (0-4%) as well as haematoma or sepsis (0-2%). Fistulation did not occur in most studies. Two procedure-related deaths were observed for 3209 patients. Although inconsistent, 78% of patients reported a satisfactory or good outcome, with 30-50% experiencing reduced symptoms of straining, incomplete emptying or reduced vaginal digitation. About 17% of patients developed anatomical recurrence. Considering measures of harm and global satisfaction rating scales, there was insufficient evidence to prefer one type of procedure over another. There was no evidence to support better outcomes based on selection of patients with a particular size or grade of rectocoele. CONCLUSION Evidence supporting recto-vaginal reinforcement procedures is currently derived from observational studies and comparisons, with only one high quality study. Large trials are needed to inform future clinical decision making.
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Affiliation(s)
- U Grossi
- National Bowel Research Centre, Blizard Institute, Queen Mary University of London, London, UK
| | - E J Horrocks
- National Bowel Research Centre, Blizard Institute, Queen Mary University of London, London, UK
| | - J Mason
- Health Economics, University of Warwick, Coventry, UK
| | - C H Knowles
- National Bowel Research Centre, Blizard Institute, Queen Mary University of London, London, UK
| | - A B Williams
- Guy's and St Thomas' NHS Foundation Trust, London, UK
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- National Institute for Health Research: Chronic Constipation Treatment Pathway, London, UK
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- Affiliate section of the Association of Coloproctology of Great Britain and Ireland, London, UK
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Abstract
OBJECTIVE To update clinical practice guidelines on graft and mesh use in transvaginal pelvic organ prolapse repair based on systematic review. DATA SOURCES Eligible studies, published through April 2015, were retrieved through ClinicalTrials.gov, MEDLINE, and Cochrane databases and bibliography searches. METHODS OF STUDY SELECTION We included studies of transvaginal prolapse repair that compared graft or mesh use with either native tissue repair or use of a different graft or mesh with anatomic and symptomatic outcomes with a minimum of 12 months of follow-up. TABULATION, INTEGRATION, AND RESULTS Study data were extracted by one reviewer and confirmed by a second reviewer. Studies were classified by vaginal compartment (anterior, posterior, apical, or multiple), graft type (biologic, synthetic absorbable, synthetic nonabsorbable), and outcome (anatomic, symptomatic, sexual function, mesh complications, and return to the operating room). We found 66 comparative studies reported in 70 articles, including 38 randomized trials; quality of the literature has improved over time, but some outcomes still show heterogeneity and limited power. In the anterior vaginal compartment, synthetic nonabsorbable mesh consistently showed improved anatomic and bulge symptom outcomes compared with native tissue repairs based on meta-analyses. Other subjective outcomes, including urinary incontinence or dyspareunia, generally did not differ. Biologic graft or synthetic absorbable mesh use did not provide an advantage in any compartment. Synthetic mesh use in the posterior or apical compartments did not improve success. Mesh erosion rates ranged from 1.4-19% at the anterior vaginal wall, but 3-36% when mesh was placed in multiple compartments. Operative mesh revision rates ranged from 3-8%. CONCLUSION Synthetic mesh augmentation of anterior wall prolapse repair improves anatomic outcomes and bulge symptoms compared with native tissue repair. Biologic grafts do not improve prolapse repair outcomes in any compartment. Mesh erosion occurred in up to 36% of patients, but reoperation rates were low.
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Niu K, Lu YX, Shen WJ, Zhang YH, Wang WY. Risk Factors for Mesh Exposure after Transvaginal Mesh Surgery. Chin Med J (Engl) 2017; 129:1795-9. [PMID: 27453227 PMCID: PMC4976566 DOI: 10.4103/0366-6999.186631] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/04/2023] Open
Abstract
Background: Mesh exposure after surgery continues to be a clinical challenge for urogynecological surgeons. The purpose of this study was to explore the risk factors for polypropylene (PP) mesh exposure after transvaginal mesh (TVM) surgery. Methods: This study included 195 patients with advanced pelvic organ prolapse (POP), who underwent TVM from January 2004 to December 2012 at the First Affiliated Hospital of Chinese PLA General Hospital. Clinical data were evaluated including patient's demography, TVM type, concomitant procedures, operation time, blood loss, postoperative morbidity, and mesh exposure. Mesh exposure was identified through postoperative vaginal examination. Statistical analysis was performed to identify risk factors for mesh exposure. Results: Two-hundred and nine transvaginal PP meshes were placed, including 194 in the anterior wall and 15 in the posterior wall. Concomitant tension-free vaginal tape was performed in 61 cases. The mean follow-up time was 35.1 ± 23.6 months. PP mesh exposure was identified in 32 cases (16.4%), with 31 in the anterior wall and 1 in the posterior wall. Significant difference was found in operating time and concomitant procedures between exposed and nonexposed groups (F = 7.443, P = 0.007; F = 4.307, P = 0.039, respectively). Binary logistic regression revealed that the number of concomitant procedures and operation time were risk factors for mesh exposure (P = 0.001, P = 0.043). Conclusion: Concomitant procedures and increased operating time increase the risk for postoperative mesh exposure in patients undergoing TVM surgery for POP.
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Affiliation(s)
- Ke Niu
- Department of Gynaecology and Obstetrics, First Affiliated Hospital of Chinese PLA General Hospital, Beijing 100048, China
| | - Yong-Xian Lu
- Department of Gynaecology and Obstetrics, First Affiliated Hospital of Chinese PLA General Hospital, Beijing 100048, China
| | - Wen-Jie Shen
- Department of Gynaecology and Obstetrics, First Affiliated Hospital of Chinese PLA General Hospital, Beijing 100048, China
| | - Ying-Hui Zhang
- Department of Gynaecology and Obstetrics, First Affiliated Hospital of Chinese PLA General Hospital, Beijing 100048, China
| | - Wen-Ying Wang
- Department of Gynaecology and Obstetrics, First Affiliated Hospital of Chinese PLA General Hospital, Beijing 100048, China
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Abstract
Rectoceles are a very common finding in patients, and symptoms most commonly include pelvic pain, pressure, or difficulty with passing stool. However, there are often other associated pelvic floor disorders that accompany rectoceles, making the clinical significance of it in an individual patient often hard to determine. When evaluating a patient with a rectocele, a thorough history and physical exam must be conducted to help delineate other causes of these symptoms. Treatment consists of addressing other defecatory disorders through various methods, with surgery reserved for select cases in which obstructed defecation is well documented.
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Affiliation(s)
- W Conan Mustain
- Division of Colon and Rectal Surgery, Department of Surgery, University of Arkansas for Medical Sciences, Little Rock, Arkansas
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31
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Maher C, Feiner B, Baessler K, Christmann‐Schmid C, Haya N, Brown J. Surgery for women with anterior compartment prolapse. Cochrane Database Syst Rev 2016; 11:CD004014. [PMID: 27901278 PMCID: PMC6464975 DOI: 10.1002/14651858.cd004014.pub6] [Citation(s) in RCA: 69] [Impact Index Per Article: 7.7] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/21/2022]
Abstract
BACKGROUND To minimise the rate of recurrent prolapse after traditional native tissue repair (anterior colporrhaphy), clinicians have utilised a variety of surgical techniques. OBJECTIVES To determine the safety and effectiveness of surgery for anterior compartment prolapse. SEARCH METHODS We searched the Cochrane Incontinence Group Specialised Register, including the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In Process (23 August 2016), handsearched journals and conference proceedings (15 February 2016) and searched trial registers (1 August 2016). SELECTION CRITERIA Randomised controlled trials (RCTs) that examined surgical operations for anterior compartment prolapse. DATA COLLECTION AND ANALYSIS Two review authors independently selected trials, assessed risk of bias and extracted data. Primary outcomes were awareness of prolapse, repeat surgery and recurrent prolapse on examination. MAIN RESULTS We included 33 trials (3332 women). The quality of evidence ranged from very low to moderate. Limitations were risk of bias and imprecision. We have summarised results for the main comparisons. Native tissue versus biological graft Awareness of prolapse: Evidence suggested few or no differences between groups (risk ratio (RR) 0.98, 95% confidence interval (CI) 0.52 to 1.82; five RCTs; 552 women; I2 = 39%; low-quality evidence), indicating that if 12% of women were aware of prolapse after biological graft, 7% to 23% would be aware after native tissue repair. Repeat surgery for prolapse: Results showed no probable differences between groups (RR 1.02, 95% CI 0.53 to 1.97; seven RCTs; 650 women; I2 = 0%; moderate-quality evidence), indicating that if 4% of women required repeat surgery after biological graft, 2% to 9% would do so after native tissue repair. Recurrent anterior compartment prolapse: Native tissue repair probably increased the risk of recurrence (RR 1.32, 95% CI 1.06 to 1.65; eight RCTs; 701 women; I2 = 26%; moderate-quality evidence), indicating that if 26% of women had recurrent prolapse after biological graft, 27% to 42% would have recurrence after native tissue repair. Stress urinary incontinence (SUI): Results showed no probable differences between groups (RR 1.44, 95% CI 0.79 to 2.64; two RCTs; 218 women; I2 = 0%; moderate-quality evidence). Dyspareunia: Evidence suggested few or no differences between groups (RR 0.87, 95% CI 0.39 to 1.93; two RCTs; 151 women; I2 = 0%; low-quality evidence). Native tissue versus polypropylene mesh Awareness of prolapse: This was probably more likely after native tissue repair (RR 1.77, 95% CI 1.37 to 2.28; nine RCTs; 1133 women; I2 = 0%; moderate-quality evidence), suggesting that if 13% of women were aware of prolapse after mesh repair, 18% to 30% would be aware of prolapse after native tissue repair. Repeat surgery for prolapse: This was probably more likely after native tissue repair (RR 2.03, 95% CI 1.15 to 3.58; 12 RCTs; 1629 women; I2 = 39%; moderate-quality evidence), suggesting that if 2% of women needed repeat surgery after mesh repair, 2% to 7% would do so after native tissue repair. Recurrent anterior compartment prolapse: This was probably more likely after native tissue repair (RR 3.01, 95% CI 2.52 to 3.60; 16 RCTs; 1976 women; I2 = 39%; moderate-quality evidence), suggesting that if recurrent prolapse occurred in 13% of women after mesh repair, 32% to 45% would have recurrence after native tissue repair. Repeat surgery for prolapse, stress urinary incontinence or mesh exposure (composite outcome): This was probably less likely after native tissue repair (RR 0.59, 95% CI 0.41 to 0.83; 12 RCTs; 1527 women; I2 = 45%; moderate-quality evidence), suggesting that if 10% of women require repeat surgery after polypropylene mesh repair, 4% to 8% would do so after native tissue repair. De novo SUI: Evidence suggested few or no differences between groups (RR 0.67, 95% CI 0.44 to 1.01; six RCTs; 957 women; I2 = 26%; low-quality evidence). No evidence suggested a difference in rates of repeat surgery for SUI. Dyspareunia (de novo): Evidence suggested few or no differences between groups (RR 0.54, 95% CI 0.27 to 1.06; eight RCTs; n = 583; I2 = 0%; low-quality evidence). Native tissue versus absorbable mesh Awareness of prolapse: It is unclear whether results showed any differences between groups (RR 0.95, 95% CI 0.70 to 1.31; one RCT; n = 54; very low-quality evidence), Repeat surgery for prolapse: It is unclear whether results showed any differences between groups (RR 2.13, 95% CI 0.42 to 10.82; one RCT; n = 66; very low-quality evidence). Recurrent anterior compartment prolapse: This is probably more likely after native tissue repair (RR 1.50, 95% CI 1.09 to 2.06; three RCTs; n = 268; I2 = 0%; moderate-quality evidence), suggesting that if 27% have recurrent prolapse after mesh repair, 29% to 55% would have recurrent prolapse after native tissue repair. SUI: It is unclear whether results showed any differences between groups (RR 0.72, 95% CI 0.50 to 1.05; one RCT; n = 49; very low-quality evidence). Dyspareunia: No data were reported. AUTHORS' CONCLUSIONS Biological graft repair or absorbable mesh provides minimal advantage compared with native tissue repair.Native tissue repair was associated with increased awareness of prolapse and increased risk of repeat surgery for prolapse and recurrence of anterior compartment prolapse compared with polypropylene mesh repair. However, native tissue repair was associated with reduced risk of de novo SUI, reduced bladder injury, and reduced rates of repeat surgery for prolapse, stress urinary incontinence and mesh exposure (composite outcome).Current evidence does not support the use of mesh repair compared with native tissue repair for anterior compartment prolapse owing to increased morbidity.Many transvaginal polypropylene meshes have been voluntarily removed from the market, and newer light-weight transvaginal meshes that are available have not been assessed by RCTs. Clinicans and women should be cautious when utilising these products, as their safety and efficacy have not been established.
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Affiliation(s)
- Christopher Maher
- Royal Brisbane and Women's HospitalUniversity QueenslandBrisbaneQueenslandAustralia
| | - Benjamin Feiner
- Hillel Yaffe Medical Center, Technion UniversityDepartment of Urogynecology & Reconstructive Pelvic SurgeryHa‐Shalom StHaderaIsrael38100
| | - Kaven Baessler
- Pelvic Floor Centre ChariteUrogynaecology DepartmentHindenburgdamm 30BerlinGermany12200
| | | | - Nir Haya
- Lady Davis Carmel Medical Center, and the Ruth and Bruce Rappaport School of Medicine, Technion‐Israel Institute of TechnologyDepartment of Obstetrics and Gynaecology6 Michal StHaifaIsrael34364
| | - Julie Brown
- The University of AucklandLiggins InstitutePark RdGraftonAucklandNew Zealand1142
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Abstract
This report reviews the success rates and complications of native tissue (nonmesh) vaginal reconstruction of pelvic organ prolapse by compartment. For apical prolapse, both uterosacral ligament suspensions and sacrospinous ligament fixations are effective and provided similar outcomes in anatomy and function with few adverse events. In the anterior compartment, traditional colporrhaphy technique is no different than ultralateral suturing. In the posterior compartment, transvaginal rectocele repair is superior to transanal repair. For uterine preservation, sacrospinous hysteropexy is not inferior to vaginal hysterectomy with uterosacral ligament suspension for treatment of apical uterovaginal prolapse.
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A Prospective Observational Study of the Classification of the Perineum and Evaluation of Perineal Repair at the Time of Posterior Colporrhaphy. Female Pelvic Med Reconstr Surg 2016; 22:453-459. [PMID: 27636214 DOI: 10.1097/spv.0000000000000314] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/26/2022]
Abstract
OBJECTIVE The aim of this prospective observational study was to obtain a better understanding of the anatomy and to classify the observed different perineal presentations at the time of posterior colporrhaphy and to describe specific surgical techniques used. METHODS To classify the observed perineal findings, the Pelvic Organ Prolapse Quantification System with a newly introduced additional measurement of the perineal ridge (PR) was taken intraoperatively and postoperatively in 121 consecutive women undergoing posterior colporrhaphy. Dependent on the preoperative classification of the perineum as being normal (type 1), deficient (type 2), or with a PR (type 3), a specific surgical repair was performed for each type of perineal presentation. RESULTS The perineal presentations were categorized into 3 defined groups. Type 1 (normal perineum) was seen in 40%, type 2 (deficient perineum) in 13%, and type 3 (PR) in 47%. A type 1 correlates with prior cesarean section (P = 0.29), a type 2 correlates with prior vaginal delivery (P = 0.05), and type 3 perineum with prior pelvic floor surgery (P < 0.0001). When perineal type-specific surgical techniques were performed, the perineal body length increased postoperatively in type 2 (P < 0.05), decreased in type 3 (P < 0.05), and remained unchanged in those with type 1 defects. CONCLUSIONS This study demonstrates that the perineal region can be clearly defined into 3 categories. The distinct perineal presentation correlates with the previous gynecological history. With a specific perineal repair at the time of posterior colporrhaphy, the perineal anatomy can be restored in the short term.
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Vaginal Mesh in Pelvic Reconstructive Surgery: Controversies, Current Use, and Complications. Clin Obstet Gynecol 2016; 58:740-53. [PMID: 26512439 DOI: 10.1097/grf.0000000000000148] [Citation(s) in RCA: 15] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/25/2022]
Abstract
In 2001, the Food and Drug Administration approved the first surgical mesh product specifically designed for the surgical repair of pelvic organ prolapse and between 2004 and 2008, the use of vaginal mesh in gynecologic surgery was at its peak. Unfortunately, the rise in transvaginal mesh use was accompanied by a surge of adverse events and mesh-related complications. As a result, the Food and Drug Administration put forth several efforts to regulate the manufacturing of vaginal mesh products. These notifications have been supported by several gynecologic societies, and recommendations now exist not only on the placement of mesh and patient selection, but also on the evaluation and management of mesh-related complications. In addition, data on outcomes following management of these complications are now emerging.
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Cour F, Le Normand L, Meurette G. Traitement par voie basse des colpocèles postérieures : recommandations pour la pratique clinique. Prog Urol 2016; 26 Suppl 1:S47-60. [DOI: 10.1016/s1166-7087(16)30428-6] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/21/2022]
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Paquette IM, Varma M, Ternent C, Melton-Meaux G, Rafferty JF, Feingold D, Steele SR. The American Society of Colon and Rectal Surgeons' Clinical Practice Guideline for the Evaluation and Management of Constipation. Dis Colon Rectum 2016; 59:479-92. [PMID: 27145304 DOI: 10.1097/dcr.0000000000000599] [Citation(s) in RCA: 60] [Impact Index Per Article: 6.7] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/08/2023]
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Attachment of Primary Vaginal Fibroblasts to Absorbable and Nonabsorbable Implant Materials Coated With Platelet-Rich Plasma: Potential Application in Pelvic Organ Prolapse Surgery. Female Pelvic Med Reconstr Surg 2016; 21:190-7. [PMID: 25900058 DOI: 10.1097/spv.0000000000000178] [Citation(s) in RCA: 20] [Impact Index Per Article: 2.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/12/2022]
Abstract
OBJECTIVES Pelvic organ prolapse (POP) is a common condition in women. The lifetime risk of undergoing surgery to correct POP is 11%, with 30% recurrence rate. Various types of vaginal implants, absorbable and nonabsorbable, that have been introduced in pelvic floor reconstructive surgeries have numerous serious adverse effects. Platelet-rich plasma (PRP) is an autologous product that accelerates tissue healing and regeneration. We hypothesized that autologous PRP will promote human vaginal fibroblast (HVF) attachment to vaginal implants and increase their healing potential. METHODS Vaginal tissue biopsies were collected from postmenopausal patients with POP (n = 10) and asymptomatic control subjects (n = 4) during vaginal hysterectomy or repair. Primary cells were isolated and characterized by immunocytochemistry. Cell attachment and proliferation were compared between POP HVFs and control HVFs (n = 4/group). Twelve weeks after the surgery, blood samples were collected from 6 POP patients to obtain autologous PRP. Two meshes, absorbable (Vicryl) and nonabsorbable (Restorelle), were coated in PRP or control media; autologous POP HVFs (n = 6) were seeded on meshes for 2 hours. Cells attached to the meshes were fixed, stained with DAPI (4,6-diamidino-2-phenylindole dihydrochloride), and counted. RESULTS Pelvic organ prolapse HVFs were similar to control HVFs in attachment to different matrix substrates and in proliferation rate. Attachment of POP HVFs to both meshes was significantly increased after coating with PRP versus Dulbecco modified Eagle medium (Vicryl: 9875 vs. 1006 cells/cm, Restorelle: 3724 vs. 649 cells/cm; P < 0.001 for both). CONCLUSIONS In vitro, primary POP HVFs show better attachment to implant materials when treated with PRP, which may lead to reduced mesh-related complications in vivo, indicating its great potential for urogynecologic surgeries.
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Native Tissue Surgery for Prolapse versus Graft/Mesh Use: Current Trends in Reconstructive Surgery. CURRENT OBSTETRICS AND GYNECOLOGY REPORTS 2016. [DOI: 10.1007/s13669-016-0147-1] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/16/2022]
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Unger CA. An Update on the Use of Mesh in Pelvic Reconstructive Surgery. CURRENT OBSTETRICS AND GYNECOLOGY REPORTS 2016. [DOI: 10.1007/s13669-016-0145-3] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/25/2022]
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Illston JD, Garris JB, Richter HE, Wheeler TL. Pain Scores and Exposure Rates after Polypropylene Mesh for Pelvic Organ Prolapse. South Med J 2016; 108:715-21. [PMID: 26630890 DOI: 10.14423/smj.0000000000000377] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/23/2022]
Abstract
OBJECTIVES To characterize pain and exposure after Prolift placement and identify risk factors. METHODS A case series of women who underwent Prolift vaginal mesh were surveyed. Pain was assessed using a visual analog scale. Exposure was evaluated clinically. RESULTS Of 183 eligible patients, 160 completed the survey, and 45 returned for examination. Mean preoperative pain score was 0.97 and postoperative was 1.35 (P = 0.12). Pre- and postoperative pain scores by compartment were: anterior (1.34 vs 1.25, mean change -0.09, P = 0.84), posterior (1.30 vs 1.56, mean change 0.26, P = 0.72), and total (0.63 vs 1.34, mean change 0.71, P = 0.05). Graft exposure was confirmed in 23 of 183 patients (12.6%); however, because asymptomatic patients were not examined, the true exposure rate may be underestimated. Hematoma formation is independently associated with mesh exposure, adjusted odds ratio 18.4 (95% confidence interval 3.4-147.4, P = 0.01). CONCLUSIONS Although pain scores did not increase overall, there was a trend toward increased pain score in the patients with total (anterior and posterior) Prolift. Hematoma formation was significantly associated with mesh exposure.
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Affiliation(s)
- Jana D Illston
- From the Greenville Health System, the Department of Obstetrics and Gynecology, University of South Carolina School of Medicine-Greenville, Greenville, and the Department of Obstetrics and Gynecology, University of Alabama at Birmingham
| | - Jeffrey B Garris
- From the Greenville Health System, the Department of Obstetrics and Gynecology, University of South Carolina School of Medicine-Greenville, Greenville, and the Department of Obstetrics and Gynecology, University of Alabama at Birmingham
| | - Holly E Richter
- From the Greenville Health System, the Department of Obstetrics and Gynecology, University of South Carolina School of Medicine-Greenville, Greenville, and the Department of Obstetrics and Gynecology, University of Alabama at Birmingham
| | - Thomas L Wheeler
- From the Greenville Health System, the Department of Obstetrics and Gynecology, University of South Carolina School of Medicine-Greenville, Greenville, and the Department of Obstetrics and Gynecology, University of Alabama at Birmingham
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Richter LA, Sokol AI. Pelvic Organ Prolapse---Vaginal and Laparoscopic Mesh: The Evidence. Obstet Gynecol Clin North Am 2016; 43:83-92. [PMID: 26880510 DOI: 10.1016/j.ogc.2015.10.004] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/26/2022]
Abstract
This report summarizes the current literature on abdominal, laparoscopic, and transvaginal mesh for the treatment of pelvic organ prolapse. This article reviews objective and subjective cure rates as well as complications associated with synthetic mesh use for pelvic organ prolapse repair. The focus is on the latest literature that provides evidence for when synthetic mesh use is most appropriate. The use of mesh for the repair of urinary incontinence is not reviewed in this article.
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Affiliation(s)
- Lee A Richter
- Departments of Obstetrics and Gynecology, and Urology, National Center for Advanced Pelvic Surgery, MedStar Washington Hospital Center, 106 Irving Street NW POB South #405, Washington, DC 20010, USA.
| | - Andrew I Sokol
- Departments of Obstetrics and Gynecology, and Urology, National Center for Advanced Pelvic Surgery, MedStar Washington Hospital Center, 106 Irving Street NW POB South #405, Washington, DC 20010, USA
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Guyomard A, Delorme E. Transvaginal treatment of anterior or central urogenital prolapse using six tension-free straps and light mesh. Int J Gynaecol Obstet 2016; 133:365-9. [DOI: 10.1016/j.ijgo.2015.10.016] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/18/2015] [Revised: 10/02/2015] [Accepted: 02/03/2016] [Indexed: 12/21/2022]
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Maher C, Feiner B, Baessler K, Christmann‐Schmid C, Haya N, Marjoribanks J. Transvaginal mesh or grafts compared with native tissue repair for vaginal prolapse. Cochrane Database Syst Rev 2016; 2:CD012079. [PMID: 26858090 PMCID: PMC6489145 DOI: 10.1002/14651858.cd012079] [Citation(s) in RCA: 121] [Impact Index Per Article: 13.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/29/2022]
Abstract
BACKGROUND A wide variety of grafts have been introduced with the aim of improving the outcomes of traditional native tissue repair (colporrhaphy) for vaginal prolapse. OBJECTIVES To determine the safety and effectiveness of transvaginal mesh or biological grafts compared to native tissue repair for vaginal prolapse. SEARCH METHODS We searched the Cochrane Incontinence Group Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, ongoing trials registers, and handsearching of journals and conference proceedings (6 July 2015). We also contacted researchers in the field. SELECTION CRITERIA Randomised controlled trials (RCTs) comparing different types of vaginal repair (mesh, biological graft, or native tissue). DATA COLLECTION AND ANALYSIS Two review authors independently selected trials, assessed risk of bias, and extracted data. The primary outcomes were awareness of prolapse, repeat surgery, and recurrent prolapse on examination. MAIN RESULTS We included 37 RCTs (4023 women). The quality of the evidence ranged from very low to moderate. The main limitations were poor reporting of study methods, inconsistency, and imprecision. Permanent mesh versus native tissue repairAwareness of prolapse at one to three years was less likely after mesh repair (risk ratio (RR) 0.66, 95% confidence interval (CI) 0.54 to 0.81, 12 RCTs, n = 1614, I(2) = 3%, moderate-quality evidence). This suggests that if 19% of women are aware of prolapse after native tissue repair, between 10% and 15% will be aware of prolapse after permanent mesh repair.Rates of repeat surgery for prolapse were lower in the mesh group (RR 0.53, 95% CI 0.31 to 0.88, 12 RCTs, n = 1675, I(2) = 0%, moderate-quality evidence). There was no evidence of a difference between the groups in rates of repeat surgery for continence (RR 1.07, 95% CI 0.62 to 1.83, 9 RCTs, n = 1284, I(2) = 21%, low-quality evidence). More women in the mesh group required repeat surgery for the combined outcome of prolapse, stress incontinence, or mesh exposure (RR 2.40, 95% CI 1.51 to 3.81, 7 RCTs, n = 867, I(2) = 0%, moderate-quality evidence). This suggests that if 5% of women require repeat surgery after native tissue repair, between 7% and 18% in the permanent mesh group will do so. Eight per cent of women in the mesh group required repeat surgery for mesh exposure.Recurrent prolapse on examination was less likely after mesh repair (RR 0.40, 95% CI 0.30 to 0.53, 21 RCTs, n = 2494, I(2) = 73%, low-quality evidence). This suggests that if 38% of women have recurrent prolapse after native tissue repair, between 11% and 20% will do so after mesh repair.Permanent mesh was associated with higher rates of de novo stress incontinence (RR 1.39, 95% CI 1.06 to 1.82, 12 RCTs, 1512 women, I(2) = 0%, low-quality evidence) and bladder injury (RR 3.92, 95% CI 1.62 to 9.50, 11 RCTs, n = 1514, I(2) = 0%, moderate-quality evidence). There was no evidence of a difference between the groups in rates of de novo dyspareunia (RR 0.92, 95% CI 0.58 to 1.47, 11 RCTs, n = 764, I(2) = 21%, low-quality evidence). Effects on quality of life were uncertain due to the very low-quality evidence. Absorbable mesh versus native tissue repairThere was very low-quality evidence for the effectiveness of either form of repair at two years on the rate of awareness of prolapse (RR 1.05, 95% CI 0.77 to 1.44, 1 RCT, n = 54).There was very low-quality evidence for the effectiveness of either form of repair on the rate of repeat surgery for prolapse (RR 0.47, 95% CI 0.09 to 2.40, 1 RCT, n = 66).Recurrent prolapse on examination was less likely in the mesh group (RR 0.71, 95% CI 0.52 to 0.96, 3 RCTs, n = 292, I(2) = 21%, low-quality evidence)The effect of either form of repair was uncertain for urinary outcomes, dyspareunia, and quality of life. Biological graft versus native tissue repairThere was no evidence of a difference between the groups at one to three years for the outcome awareness of prolapse (RR 0.97, 95% CI 0.65 to 1.43, 7 RCTs, n = 777, low-quality evidence).There was no evidence of a difference between the groups for the outcome repeat surgery for prolapse (RR 1.22, 95% CI 0.61 to 2.44, 5 RCTs, n = 306, I(2) = 8%, low-quality evidence).The effect of either approach was very uncertain for recurrent prolapse (RR 0.94, 95% CI 0.60 to 1.47, 7 RCTs, n = 587, I(2) = 59%, very low-quality evidence).There was no evidence of a difference between the groups for dyspareunia or quality of life outcomes (very low-quality evidence). AUTHORS' CONCLUSIONS While transvaginal permanent mesh is associated with lower rates of awareness of prolapse, reoperation for prolapse, and prolapse on examination than native tissue repair, it is also associated with higher rates of reoperation for prolapse, stress urinary incontinence, or mesh exposure and higher rates of bladder injury at surgery and de novo stress urinary incontinence. The risk-benefit profile means that transvaginal mesh has limited utility in primary surgery. While it is possible that in women with higher risk of recurrence the benefits may outweigh the risks, there is currently no evidence to support this position.Limited evidence suggests that absorbable mesh may reduce rates of recurrent prolapse on examination compared to native tissue repair, but there was insufficient evidence on absorbable mesh for us to draw any conclusions for other outcomes. There was also insufficient evidence for us to draw any conclusions regarding biological grafts compared to native tissue repair.In 2011, many transvaginal permanent meshes were voluntarily withdrawn from the market, and the newer, lightweight transvaginal permanent meshes still available have not been evaluated within a RCT. In the meantime, these newer transvaginal meshes should be utilised under the discretion of the ethics committee.
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Affiliation(s)
- Christopher Maher
- Royal Brisbane and Women's HospitalUniversity QueenslandBrisbaneAustralia
| | - Benjamin Feiner
- Hillel Yaffe Medical Center, Technion UniversityDepartment of Urogynecology & Reconstructive Pelvic SurgeryHa‐Shalom StHaderaIsrael38100
| | - Kaven Baessler
- Pelvic Floor Centre ChariteUrogynaecology DepartmentHindenburgdamm 30BerlinGermany12200
| | | | - Nir Haya
- Lady Davis Carmel Medical Center, and the Ruth and Bruce Rappaport School of
Medicine, Technion‐Israel Institute of TechnologyDepartment of Obstetrics and Gynaecology6 Michal StHaifaIsrael34364
| | - Jane Marjoribanks
- University of AucklandDepartment of Obstetrics and GynaecologyPark RdGraftonAucklandNew Zealand1003
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Sun Y, Tang C, Luo D, Yang L, Shen H. The treatment of anterior vaginal wall prolapsed by repair with mesh versus colporrhaphy. Int Urol Nephrol 2015; 48:155-67. [PMID: 26685887 DOI: 10.1007/s11255-015-1179-6] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/01/2015] [Accepted: 11/30/2015] [Indexed: 02/05/2023]
Abstract
PURPOSE To compare patient outcomes of mesh repair and colporrhaphy for the treatment of anterior vaginal wall prolapse (AVP). MATERIALS AND METHODS We searched PubMed(®), Embase(®), and Cochrane Library databases to identify the included studies. The outcome measures included anatomical success, patient satisfaction, patient sexual function, perioperative data, and complications. Statistical analyses were performed using Cochrane Collaboration Review Manager software (RevMan 5.1.4). RESULTS The study inclusion criteria were met by 11 articles involving 1455 patients. Synthesized data indicated that mesh surgery was more complex than colporrhaphy with regard to perioperative condition [mean difference (MD) 0.28, 95% confidence interval (CI) 0.07-0.49, p = 0.010]. There were no significant differences for the following complications: urinary retention [relative risk (RR) 1.12, 95% CI 0.65-1.94, p = 0.68], urinary incontinence (RR 1.01, 95% CI 0.63-1.63, p = 0.96), voiding difficulty (RR 1.11, 95% CI 0.69-1.80, p = 0.66), dyspareunia (RR 1.21, 95% CI 0.87-1.67, p = 0.26), urinary tract infection (RR 1.15, 95% CI 0.74-1.78, p = 0.53), and vaginal bulge (RR 1.08, 95% CI 0.93-1.25, p = 0.32). There were instances of more serious complications in group 1, i.e., the mesh group. However, AVP cure rate was significantly higher in the mesh group (RR 1.44, 95% CI 1.34-1.55, p < 0.00001). The cure rate was not significantly dependent on patient satisfaction (RR 1.10, 95% CI 0.96-1.26, p = 0.16) or postoperative sexual function (RR 1.03, 95% CI 0.90-1.11, p = 0.71). CONCLUSIONS Surgical repair with the mesh procedure appears to be a better choice for the treatment of anterior vaginal wall prolapse.
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Affiliation(s)
- Yi Sun
- Department of Urology, West China Hospital, Sichuan University, No. 37 Guoxue Xiang, Chengdu, 610041, Sichuan, People's Republic of China
| | - Cai Tang
- Department of Urology, West China Hospital, Sichuan University, No. 37 Guoxue Xiang, Chengdu, 610041, Sichuan, People's Republic of China
| | - Deyi Luo
- Department of Urology, West China Hospital, Sichuan University, No. 37 Guoxue Xiang, Chengdu, 610041, Sichuan, People's Republic of China
| | - Lu Yang
- Department of Urology, West China Hospital, Sichuan University, No. 37 Guoxue Xiang, Chengdu, 610041, Sichuan, People's Republic of China
| | - Hong Shen
- Department of Urology, West China Hospital, Sichuan University, No. 37 Guoxue Xiang, Chengdu, 610041, Sichuan, People's Republic of China.
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Lavelle RS, Christie AL, Alhalabi F, Zimmern PE. Risk of Prolapse Recurrence after Native Tissue Anterior Vaginal Suspension Procedure with Intermediate to Long-Term Followup. J Urol 2015; 195:1014-20. [PMID: 26523882 DOI: 10.1016/j.juro.2015.10.138] [Citation(s) in RCA: 27] [Impact Index Per Article: 2.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 10/27/2015] [Indexed: 11/18/2022]
Abstract
PURPOSE We report our experience with recurrence of pelvic organ prolapse after native tissue repair for stage 2 anterior prolapse. MATERIALS AND METHODS We reviewed a prospectively maintained, institutional review board approved database of women with symptomatic stage 2 anterior prolapse who underwent vaginal repair with anterior vaginal wall suspension between 1996 and 2014. Women with concurrent pelvic organ prolapse repair or hysterectomy or without 1 year followup were excluded from analysis. Failure was defined as stage 2 or greater prolapse recurrence on examination or reoperation for symptomatic pelvic organ prolapse. Outcome measures included validated questionnaires (Urogenital Distress Inventory-short form, quality of life), physical examination, standing voiding cystourethrogram at 6 months postoperatively, further surgery for pelvic organ prolapse in other compartments or for secondary stress urinary incontinence or fecal incontinence, and complications. RESULTS A total of 121 women met the study inclusion criteria with a mean followup of 5.8 ± 3.7 years. Prolapse recurrence rates were isolated anterior 7.4%, isolated apical 10.7%, isolated posterior 8.3% and multiple compartments 19%. Surgery for recurrent prolapse included anterior compartment 3.3% at 1.4 ± 1.0 years, apical 9.9% at 2.8 ± 3.0 years, posterior compartment 5.8% at 2.0 ± 1.0 years and multiple compartments 17.4% at 3.2 ± 3.3 years. There was a 1.6% rate of intraoperative complications and a 5.7% rate of 30-day complications (all Clavien I). CONCLUSIONS Anterior vaginal wall suspension for symptomatic stage 2 anterior prolapse offers a native tissue vaginal repair with minimal morbidity and a low anterior recurrence rate at intermediate to long-term followup. However, 33% of patients required secondary prolapse compartment procedures from 0.6 to 13 years later, highlighting the importance of long-term followup.
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Brocker KA, Alt CD, Rzepka J, Sohn C, Hallscheidt P. One-year dynamic MRI follow-up after vaginal mesh repair: evaluation of clinical, radiological, and quality-of-life results. Acta Radiol 2015; 56:1002-8. [PMID: 25136056 DOI: 10.1177/0284185114544241] [Citation(s) in RCA: 10] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/26/2014] [Accepted: 06/20/2014] [Indexed: 11/16/2022]
Abstract
BACKGROUND Pelvic organ prolapse (POP) is a common disorder in elderly women often surgically repaired with alloplastic meshes; yet knowledge of the pelvic floor behavior and multi-compartment defects postoperatively is scarce. PURPOSE To evaluate the 1-year outcome after mesh repair in patients with POP using clinical examination (CE), dynamic magnetic resonance imaging (dMRI), and the prolapse quality-of-life (P-QOL) questionnaire. MATERIAL AND METHODS A prospective observational study was conducted of 69 women undergoing pelvic mesh surgery. Clinical examination, dMRI, and the P-QOL questionnaire were applied before and after surgery to evaluate POP. Mean outcome measures were POP outcome as determined on clinical and dMRI examinations and its impact on quality of life. Statistical results were obtained with SPSS version 15.0. ANOVA was used to compare pre-/postsurgical quality of life data. RESULTS Sixty-nine women (mean age, 64.75 years; BMI, 26.75 kg/m(2); postmenopausal, 89.2%) were recruited and treated with Seratom® or Perigee™ mesh implants. A significant improvement in the position of bladder neck, vaginal vault/uterus, pouch of Douglas, and rectum was found 12 weeks and 1 year after surgery using POP-Q scale and dMRI. Advanced cystoceles and enteroceles seem underestimated by CE using the POP-Q system compared to dMRI results (P = 0.003 and P < 0.001), vice versa dMRI overestimated POP compared to CE. Sixty-four women completed the P-QOL questionnaire, presenting reduced quality of life before surgery which improves postsurgically. Prolapse impact and physical, social, and role limitations correlated strongest with a low quality of life (P < 0.001). CONCLUSION The 1-year follow-up after mesh repair showed statistical and clinical improvement for all tools employed. dMRI seems a reliable tool for simultaneous assessment of defects in all three compartments, but tends to overestimate POP compared to clinical examination.
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Affiliation(s)
- Kerstin A Brocker
- Department of Obstetrics and Gynecology, University of Heidelberg, Medical School, Heidelberg, Germany
| | - Celine D Alt
- Department of Diagnostic and Interventional Radiology, University of Heidelberg, Medical School, Heidelberg, Germany
| | - Jakub Rzepka
- Department of Obstetrics and Gynecology, Medical Center of Postgraduate Education, Warsaw, Poland
| | - Christof Sohn
- Department of Obstetrics and Gynecology, University of Heidelberg, Medical School, Heidelberg, Germany
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King AB, Goldman HB. Stress incontinence surgery at the time of prolapse surgery: mandatory or forbidden? World J Urol 2015; 33:1257-62. [PMID: 25991600 DOI: 10.1007/s00345-015-1591-7] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/02/2014] [Accepted: 05/10/2015] [Indexed: 11/25/2022] Open
Abstract
INTRODUCTION Concomitant anti-incontinence surgery at the time of prolapse repair has been a long-debated topic. Still today, there remains no clear answer to this question, although in recent years the literature has become more robust with the addition of more randomized controlled trials. The lifetime risk for women of undergoing surgical correction of pelvic organ prolapse is significant, and concomitant anti-incontinence surgery is an important question during surgical planning. MATERIALS AND METHODS This review delves further into the current literature to discuss a possible algorithm for managing the risk of stress incontinence after pelvic organ prolapse repair and examines the support in the literature for the following treatment methods: (1) anti-incontinence surgery for all women undergoing pelvic organ prolapse repair, (2) anti-incontinence surgery for no women undergoing pelvic organ prolapse repair, and (3) anti-incontinence surgery in select women undergoing pelvic organ prolapse repair. CONCLUSIONS While there are data both for and against each of these approaches, after a review of the literature, we recommend anti-incontinence surgery for select women undergoing pelvic organ prolapse repair, including women with a history of symptomatic and occult stress incontinence diagnosed preoperatively.
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Affiliation(s)
- Ashley B King
- Center for Female Pelvic Medicine and Reconstructive Surgery, Glickman Urological and Kidney Institute, Cleveland Clinic Lerner College of Medicine, 9500 Euclid Ave. Q10, Cleveland, OH, 44195, USA,
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