|
1
|
Tan X, Li G, Li C, Kong C, Li H, Wu S. Animal models, treatment options, and biomaterials for female stress urinary incontinence. Front Bioeng Biotechnol 2024; 12:1414323. [PMID: 39267906 PMCID: PMC11390547 DOI: 10.3389/fbioe.2024.1414323] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/08/2024] [Accepted: 08/20/2024] [Indexed: 09/15/2024] Open
Abstract
In the quest to tackle stress urinary incontinence (SUI), the synthesis of cutting-edge biomaterials and regenerative materials has emerged as a promising frontier. Briefly, animal models like vaginal distension and bilateral ovariectomy serve as crucial platforms for unraveling the intricacies of SUI, facilitating the evaluation of innovative treatments. The spotlight, however, shines on the development and application of novel biomaterials-ranging from urethral bulking agents to nano-gel composites-which aim to bolster urethral support and foster tissue regeneration. Furthermore, the exploration of stem cell therapies, particularly those derived from adipose tissues and urine, heralds a new era of regenerative medicine, offering potential for significant improvements in urinary function. This review encapsulates the progress in biomaterials and regenerative strategies, highlighting their pivotal role in advancing the treatment of SUI, thereby opening new avenues for effective and minimally invasive solutions.
Collapse
Affiliation(s)
- Xiyang Tan
- Shenzhen Hospital, Shanghai University of Traditional Chinese Medicine, Shenzhen, China
- Department of Urology, The Third Affiliated Hospital of Shenzhen University, Shenzhen University, Shenzhen, China
- Department of Urology, The Affiliated South China Hospital of Shenzhen University, Shenzhen University, Shenzhen, China
| | - Guangzhi Li
- Department of Urology, The Third Affiliated Hospital of Shenzhen University, Shenzhen University, Shenzhen, China
| | - Chenchen Li
- Department of Urology, The Third Affiliated Hospital of Shenzhen University, Shenzhen University, Shenzhen, China
| | - Chenfan Kong
- Shenzhen Hospital, Shanghai University of Traditional Chinese Medicine, Shenzhen, China
- Department of Urology, The Third Affiliated Hospital of Shenzhen University, Shenzhen University, Shenzhen, China
- Department of Urology, The Affiliated South China Hospital of Shenzhen University, Shenzhen University, Shenzhen, China
| | - Huizhen Li
- Department of Urology, The Third Affiliated Hospital of Shenzhen University, Shenzhen University, Shenzhen, China
| | - Song Wu
- Shenzhen Hospital, Shanghai University of Traditional Chinese Medicine, Shenzhen, China
- Department of Urology, The Third Affiliated Hospital of Shenzhen University, Shenzhen University, Shenzhen, China
- Department of Urology, The Affiliated South China Hospital of Shenzhen University, Shenzhen University, Shenzhen, China
| |
Collapse
|
|
2
|
Fleischmann N, Chughtai B, Plair A, Hurtado E, Jacobson N, Segal S, Panza J, Cichowski SB. Urethral Bulking. UROGYNECOLOGY (PHILADELPHIA, PA.) 2024; 30:667-682. [PMID: 39051928 DOI: 10.1097/spv.0000000000001548] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 07/27/2024]
Abstract
OBJECTIVE This Clinical Practice Statement aims to provide clinicians with evidence-based guidance for the use of urethral bulking agents (UBAs) in the treatment of stress urinary incontinence (SUI). METHODS We conducted a structured search of the English literature published from January 1960 to November 2022. Search terms identified studies of both current and historic UBAs. Data extracted at the time of full-text review included type of study, research setting, number of participants, age group, bulking agent, primary outcome, secondary outcome, efficacy, and complications. RESULTS One thousand five hundred ninety-four nonduplicate articles were identified using the search criteria. After limiting the article types to randomized control led trials, prospective studies, guideline documents, reviews, meta-analyses, and case reports of complications, 395 studies were screened. CONCLUSIONS Based on our findings, we propose the following recommendations for clinicians when considering UBA: First, UBA is indicated in cases of demonstrable SUI. Intrinsic sphincter deficiency is not predictive of patient outcomes. Second, patients should be counseled on the risks, lack of long-term efficacy data, potential need for repeat injections, possible need for surgery for recurrent SUI, implications for future procedures, and pelvic imaging findings that may be observed after UBA. Third, UBA may be considered for initial management of SUI. Fourth, UBA is an option for patients with persistent or recurrent SUI after a sling procedure. Fifth, clinicians may prioritize UBA over surgery in specific patient populations. Sixth, polyacrylamide hydrogel demonstrates marginally improved safety and durability data over other available agents.
Collapse
Affiliation(s)
| | | | - Andre Plair
- Stony Brook Medicine University Hospital, Stony Brook, NY
| | | | - Nina Jacobson
- Hackensack Meridian School of Medicine/Jersey Shore University Medical Center, Neptune, NJ
| | - Saya Segal
- Weill Cornell Medical College, New York, NY
| | - Joseph Panza
- University of Rochester Medical Center, Rochester, NY
| | | |
Collapse
|
|
3
|
Update on Urethral Bulking for Stress Urinary Incontinence in Women. Curr Urol Rep 2022; 23:203-209. [PMID: 35781870 DOI: 10.1007/s11934-022-01099-5] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 05/24/2022] [Indexed: 11/03/2022]
Abstract
PURPOSE OF REVIEW Urethral bulking agents are an effective treatment for stress urinary incontinence in select females. The material and techniques used for urethral bulking are constantly evolving. With the introduction of several new agents, there is an ongoing debate over which agent is the most effective, durable, and safe. RECENT FINDINGS Current available bulking agents include Bulkamid®, Macroplastiue®, Durasphere®, Coaptite®, or Urolastic®. Each of these agents has its own biophysical properties that affect its efficacy and safety. Evidence evaluating bulking agents has increased over time but there is no definitive data that suggest superiority of one agent over another. The ideal urethral bulking agent for female stress incontinence has yet been identified. Currently available agents have acceptable short-term and medium-term efficacy with few adverse events.
Collapse
|
|
4
|
Chen H, Shipov A, Segev G. Evaluation of cross-linked gelatin as a bulking agent for the management of urinary sphincter mechanism incompetence in female dogs. J Vet Intern Med 2020; 34:1914-1919. [PMID: 32686187 PMCID: PMC7517489 DOI: 10.1111/jvim.15857] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/10/2019] [Revised: 06/20/2020] [Accepted: 06/26/2020] [Indexed: 11/28/2022] Open
Abstract
BACKGROUND Bulking agent implantation is a minimally invasive intervention for the management of urethral sphincter mechanism incompetence (USMI). HYPOTHESIS/OBJECTIVES To evaluate the efficacy and safety of the novel bulking agent VetFoam for the management of urinary incontinence in female dogs diagnosed with USMI. ANIMALS Fifteen client-owned female dogs. METHODS Prospective study. Female dogs diagnosed with USMI, refractory, or unamenable to medical treatment were included. VetFoam was injected under endoscopic guidance into the urethral submucosa. Continence score was evaluated before and after the procedure and monthly thereafter. RESULTS Twenty-two injection procedures were performed in 15 dogs (5 dogs underwent >1 procedure). Median age of all dogs at the time of the procedure was 111 months (range, 18-180). Median continence score significantly increased after, compared with before bulking agent injection (1.5; range, 1.0-3.5 versus 4.0; range, 1.5-5 respectively; P < .001; effect size, 2.6). Continence was achieved in 13/15 (87%) dogs after the first procedure and in 7/7 (100%) repeated procedures. Overall, 20/22 (91%) procedures resulted in high (≥4) continence scores at time of first follow-up. Mean duration of continence was 11.1 months (SD, 10.7) after the first injection. One dog (7%) developed self-limiting stranguria, pollakiuria, and tenesmus while no other apparent adverse effects were recognized in the other dogs. CONCLUSIONS AND CLINICAL IMPORTANCE VetFoam is an apparently safe, effective novel bulking agent, which can be used as an alternative for the management of USMI.
Collapse
Affiliation(s)
- Hilla Chen
- Veterinary Teaching Hospital, Koret School of Veterinary Medicine, The Hebrew University of JerusalemRehovotIsrael
| | - Anna Shipov
- Veterinary Teaching Hospital, Koret School of Veterinary Medicine, The Hebrew University of JerusalemRehovotIsrael
| | - Gilad Segev
- Veterinary Teaching Hospital, Koret School of Veterinary Medicine, The Hebrew University of JerusalemRehovotIsrael
| |
Collapse
|
|
5
|
Joint Report on Terminology for Surgical Procedures to Treat Stress Urinary Incontinence in Women. Female Pelvic Med Reconstr Surg 2020; 26:162-172. [PMID: 32079836 DOI: 10.1097/spv.0000000000000831] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/26/2022]
Abstract
INTRODUCTION AND HYPOTHESIS Standardized terminology for surgical procedures commonly performed to treat stress urinary incontinence in women is needed to facilitate research, clinical care, and teaching in female pelvic medicine and reconstructive surgery. METHODS This report combines the input of members of the American Urogynecologic Society and the International Urogynecological Association, assisted by external referees. Extensive searches of the literature were performed, including Instructions for Use brochures and original source documents where possible. Historical context was considered along with procedural modifications, and expert opinion was included when appropriate. RESULTS A terminology report for the procedures commonly performed to treat stress urinary incontinence in women was produced. Included procedures are midurethral sling, retropubic colposuspension, pubovaginal sling, urethral bulking, and artificial urinary sphincter. Appropriate figures have been included to supplement and help clarify the text. Ongoing review will be performed periodically to keep the document updated and widely acceptable. CONCLUSIONS This document is a literature and consensus-based terminology report for surgical procedures to treat stress urinary incontinence in women. Future publications in female pelvic medicine and reconstructive surgery should use this standardized terminology whenever possible.
Collapse
|
|
6
|
Joint report on the terminology for surgical procedures to treat stress urinary incontinence in women. Int Urogynecol J 2020; 31:465-478. [DOI: 10.1007/s00192-020-04237-0] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/03/2023]
|
|
7
|
Chapple C, Dmochowski R. Particulate Versus Non-Particulate Bulking Agents In The Treatment Of Stress Urinary Incontinence. Res Rep Urol 2019; 11:299-310. [PMID: 31815111 PMCID: PMC6858835 DOI: 10.2147/rru.s220216] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/21/2019] [Accepted: 09/24/2019] [Indexed: 12/13/2022] Open
Abstract
Stress urinary incontinence (SUI) has been treated surgically with the midurethral sling but in recent years, this option has come under scrutiny and the risk-benefit balance continues to be reviewed. The low-risk alternative for women with uncomplicated SUI is the bulking agent, which aims to achieve continence through coaptation of the urethra. Two classes of bulking agents can be identified: those made from solid microparticles in an absorbable liquid or gel carrier (particulate agents) and those comprising a homogenous gel (non-particulates) that resists absorption. Polydimethylsiloxane®, carbon-coated zirconium oxide®, calcium hydroxyapatite® and polyacrylate polyalcohol copolymer® are currently marketed particulate agents. With the exception of calcium hydroxyapatite, the particles are non-degradable. Each agent achieves its long-term bulking effect through reactive changes around the persisting particles while the carrier volume is lost. Bulkamid® is a non-particulate agent with the bulking effect resulting from the volume of gel injected. The lasting network of fine fibers formed by the host tissue anchors the gel in situ. Foreign-body granulomas, erosion and migration/material extrusion and loss of bulk have been observed in connection with the particle-based products. Bulkamid may be mechanistically less liable to these events; however, there are minimal data directly comparing the two types of bulking agent. The question of durability is inevitable based on their differing modes of action.
Collapse
Affiliation(s)
| | - Roger Dmochowski
- Department of Urology, Vanderbilt University Medical Center, Nashville, TN, USA
| |
Collapse
|
|
8
|
Cour F, Le Normand L, Lapray JF, Hermieu JF, Peyrat L, Yiou R, Donon L, Wagner L, Vidart A. [Intrinsic sphincter deficiency and female urinary incontinence]. Prog Urol 2015; 25:437-54. [PMID: 25864653 DOI: 10.1016/j.purol.2015.03.006] [Citation(s) in RCA: 15] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/20/2014] [Revised: 03/12/2015] [Accepted: 03/16/2015] [Indexed: 11/15/2022]
Abstract
OBJECTIVE Stress urinary female incontinence (SUI) is primary due to intrinsic sphincter deficiency (ISD) and urethral hypermobility. Despite a lack of standardised international definition, ISD needs to be clearly diagnosed in order to be correctly treated. This work is an update about the female ISD produced from a review of a published article. MATERIAL AND METHODS This review of article published on this subject in the Medline (Pubmed database), selected according to their scientific relevants, of consensus conferences and published guidelines, has been performed by the committee for women pelvic floor surgery of the French Urological Association. RESULTS Although there is no international consensus definition, we can consider that the ISD is a composite concept combining urodynamic data (MUCP < 20 or 30 cmH20) and one or more clinical information (no urethral mobility, negative urethral support test, failure of a first surgery, leakage during abdominal straining, high stress incontinence scores). Imaging can provide additional evidence for intrinsic sphincter deficiency diagnosis, but the correlation between imaging and function remains low. By standardizing methodology and interpretations to better diagnose women with ISD, it may be possible to improve preoperative planning and outcomes for these patients. A retropubic midurethral sling can be performed as a first surgery. In case of a lack of urethral mobility, the artificial urinary sphincter (AUS) remains the gold standard. Adjustable continence therapy (ACT(®)) can be proposed as an alternative option. The efficacy and safety of muscle-derived cell therapy in ISD needs more studies. Injection of bulking agents may be an option according to the severity and the expectations of the patient. Bladder overactivity needs to be treated as first-line in case of mixed urinary incontinence. In elderly women, a careful evaluation of the bladder contractility and comorbidity must be performed. A geriatric evaluation can be necessary. CONCLUSION Clinical and paraclinical assessment allow to confirm the diagnosis of female ISD, to estimate its severity, and to identify associated mechanisms of incontinence (urethral hypermobility, bladder overactivity) to choose the most adapted treatment.
Collapse
Affiliation(s)
- F Cour
- Service d'urologie, hôpital Foch, 40, rue Worth, 92150 Suresnes, France; Université de Versailles-Saint-Quentin-en-Yvelines, 55, avenue de Paris, 78035 Versailles cedex, France
| | - L Le Normand
- Service d'urologie, CHU de Nantes, place A.-Ricordeau, 44093 Nantes cedex 01, France.
| | - J-F Lapray
- Centre de radiologie, 151, avenue de Saxe, 69003 Lyon, France
| | - J-F Hermieu
- Service d'urologie, CHU Bichat, 46, rue Henri-Huchard, 75877 Paris cedex 18, France
| | - L Peyrat
- Service d'urologie, CHU Tenon, 4, rue de la Chine, 75020 Paris, France
| | - R Yiou
- Service d'urologie, CHU Henri-Mondor, 51, avenue du Maréchal-de-Lattre-de-Tassigny, 94010 Créteil, France
| | - L Donon
- Service d'urologie, CHU de Bordeaux, place Amélie-Raba-Léon, 33000 Bordeaux, France
| | - L Wagner
- Service d'urologie, CHU de Nîmes, place du Pr-Debré, 30065 Nîmes cedex 09, France
| | - A Vidart
- Service d'urologie, hôpital Foch, 40, rue Worth, 92150 Suresnes, France; Université de Versailles-Saint-Quentin-en-Yvelines, 55, avenue de Paris, 78035 Versailles cedex, France
| | | |
Collapse
|
|
9
|
Bayrak O, Mock S, Dmochowski RR. Injectable treatments for female stress urinary incontinence. World J Clin Urol 2014; 3:209-217. [DOI: 10.5410/wjcu.v3.i3.209] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/09/2014] [Revised: 05/13/2014] [Accepted: 07/15/2014] [Indexed: 02/06/2023] Open
Abstract
The use of injectable agents for the treatment of stress urinary incontinence (SUI) is an option for female patients who are unwilling to undergo surgery, or have concurrent conditions or diseases that render surgical treatment unsuitable. To be effective for SUI, an injectable agent must be nonimmunogenic, hypoallergenic, biocompatible, permanent, nonerosive, nonmigratory and painless. It must also heal with minimal fibrosis, possess a long-term bulking effect, and be easily stored and handled. Glutaraldehyde cross-linked bovine collagen (Contigen), silicone polymers (Macroplastique), Durasphere, calcium hydroxyapatite (Coaptite), polyacrylamide hydrogel (Aquamid, Bulkamid), Permacol, and stem cell therapy have been used as injectable agents. Patients must be informed that treatment with injectable agents is not as effective as surgical treatment, and that such agents might necessitate additional and repeated administrations in order to achieve the desired therapeutic effect.
Collapse
|
|
10
|
MacLachlan LS, Rovner ES. Current Status of Bulking Agents for Urinary Incontinence. CURRENT BLADDER DYSFUNCTION REPORTS 2014. [DOI: 10.1007/s11884-013-0216-5] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/26/2022]
|
|
11
|
Mukkamala A, Latini JM, Cameron AP. Urethrocutaneous fistula after use of Tegress bulking agent: Case report and review of the literature. Can Urol Assoc J 2014; 7:E833-6. [PMID: 24475008 DOI: 10.5489/cuaj.481] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/19/2022]
Abstract
We report a case of a 68-year-old man who presented with a urethrocutaneous fistula after off-label use of Tegress (C. R. Bard, Inc., Murray Hill, NJ) Urethral Implant for post-prostatectomy incontinence. He was treated for prostate cancer with an open radical retropubic prostatectomy and adjuvant external beam radiation therapy. He was treated unsuccessfully for stress incontinence with a Tegress Urethral Implant and presented to our clinic initially with extrusion of the material urethrally. Four years later he re-presented with a large bullous skin lesion on his suprapubic area. Contrast-enhanced magnetic resonance imaging and retrograde urethral cystogram demonstrated a urethrocutaneous fistula. Subsequent cystoscopy revealed the calcified extruded material in the same location as the site of Tegress injection. The patient underwent simple cystectomy with ileal diversion. He recovered well postoperatively. This appears to be the first reported case of urethrocutaneous fistula after use of a Tegress Urethral Implant for post-prostatectomy stress urinary incontinence.
Collapse
Affiliation(s)
- Anudeep Mukkamala
- Department of Urology, University of Michigan Hospitals and Health Centers, Ann Arbor, MI
| | - Jerilyn M Latini
- Department of Urology, University of Michigan Hospitals and Health Centers, Ann Arbor, MI
| | - Anne P Cameron
- Department of Urology, University of Michigan Hospitals and Health Centers, Ann Arbor, MI
| |
Collapse
|
|
12
|
Lightner DJ, Fox JA. Bulking agents for urinary incontinence: patient selection, counseling and technique. ACTA ACUST UNITED AC 2014. [DOI: 10.1586/eog.09.38] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/19/2022]
|
|
13
|
Injectable biomaterials for the treatment of stress urinary incontinence: their potential and pitfalls as urethral bulking agents. Int Urogynecol J 2012; 24:913-9. [DOI: 10.1007/s00192-012-2011-9] [Citation(s) in RCA: 48] [Impact Index Per Article: 3.7] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/23/2012] [Accepted: 11/22/2012] [Indexed: 10/27/2022]
|
|
14
|
Abstract
A bulking agent is a material injected into the wall of the urethra to improve urethral coaptation in women suffering from stress incontinence. The concept was initially described in the 1930s when sodium morrhuate and paraffin were used to augment urethral resistance. Sclerosing agents were also used for inducing permanent urethral scaring to improve urinary leakage. Eventually, collagen and autologous fat were found to be efficacious, and only collagen demonstrated proven safety and endured extensive testing, becoming the gold standard for injectable agents. Since then, multiple other products have been developed by the industry, each with its particular success rates and complications.
Collapse
Affiliation(s)
- Dani Zoorob
- Department of Obstetrics and Gynecology, The Christ Hospital/University of Cincinnati, Cincinnati, OH 45267, USA
| | | |
Collapse
|
|
15
|
|
|
16
|
Toozs-Hobson P, Al-Singary W, Fynes M, Tegerstedt G, Lose G. Two-year follow-up of an open-label multicenter study of polyacrylamide hydrogel (Bulkamid®) for female stress and stress-predominant mixed incontinence. Int Urogynecol J 2012; 23:1373-8. [PMID: 22531952 PMCID: PMC3448051 DOI: 10.1007/s00192-012-1761-8] [Citation(s) in RCA: 54] [Impact Index Per Article: 4.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/25/2011] [Accepted: 03/18/2012] [Indexed: 12/04/2022]
Abstract
INTRODUCTION AND HYPOTHESIS Polyacrylamide hydrogel (PAHG, Bulkamid®) is a promising urethral bulking agent. This article presents the 2-year follow-up results of a multicenter study of PAHG injections for treating stress and stress-predominant mixed urinary incontinence. METHODS Submucosal injection of PAHG was performed in 135 women with urinary incontinence, with subjective and objective assessment of the efficacy and safety 24 months postinjection. RESULTS At 24 months, the subjective responder rate was 64 % (a statistically non-significant reduction from 67 % at 12 months). The decreased number of incontinence episodes and urine leakage were maintained compared with the result from the 12-month evaluations, as were objective result rates and quality of life data. No safety issues occurred. CONCLUSIONS PAHG is an effective and safe treatment option for women with stress-predominant mixed urinary incontinence, with maintained medium-term responder rates.
Collapse
Affiliation(s)
- Philip Toozs-Hobson
- Department of Urogynaecology, Birmingham Women’s Hospital, Methchley Lane, Edgbaston, Birmingham B15 2TG UK
| | - Waleed Al-Singary
- Worthing Hospital, Department of Urology, Lyndhurst Road, Worthing, West Sussex BN11 2DH UK
| | - Michelle Fynes
- Department of Gynaecology, St George’s Healthcare NHS Trust, Blackshaw Road, Tooting, London, SW17 0QT UK
| | - Gunilla Tegerstedt
- Department of Obstetrics & Gynaecology, Karolinska University Hospital Huddinge, Hälsovägen, Flemmingsberg, 14186 Stockholm, Sweden
| | - Gunnar Lose
- Department of Obstetrics and Gynaecology, Herlev County Hospital, University of Copenhagen, Herlev Ringvej 75, 2730 Herlev, Denmark
| |
Collapse
|
|
17
|
Abstract
Urethral bulking therapy (UBT) is a minimally invasive procedure for stress urinary incontinence that is beneficial for properly selected patients. Many different materials are available for UBT, although none fulfill all the qualities of an ideal agent. In general, short-term clinical results are encouraging; however, over longer follow-up, results are disappointing and retreatment is often necessary. Proper patient selection and management of patient expectations are paramount to successful application of UBT.
Collapse
Affiliation(s)
- W Stuart Reynolds
- Department of Urologic Surgery, Vanderbilt University Medical Center, Nashville, TN 37232-2765, USA.
| | | |
Collapse
|
|
18
|
Use of Injectable Urethral Bulking Agents in the Management of Stress Urinary Incontinence. CURRENT BLADDER DYSFUNCTION REPORTS 2011. [DOI: 10.1007/s11884-011-0104-9] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/17/2022]
|
|
19
|
Cameron AP, Haraway AM. The treatment of female stress urinary incontinence: an evidenced-based review. Open Access J Urol 2011; 3:109-20. [PMID: 24198643 PMCID: PMC3818941 DOI: 10.2147/oaju.s10541] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/31/2023] Open
Abstract
OBJECTIVE To review the literature on the surgical and nonsurgical treatment options for stress urinary incontinence in women, focusing exclusively on randomized clinical trials and high quality meta-analyses. MATERIALS AND METHODS A computer-aided and manual search for published randomized controlled trials and high quality meta-analyses investigating both conservative and surgical treatment options for stress urinary incontinence. In the case of a treatment that is not studied in these formats large case series have been used. RESULTS Articles were reviewed and the results summarized on pelvic floor physical therapy, pharmacotherapy, bulking agents, and surgery (open and minimally invasive). CONCLUSION There are numerous high quality studies in the literature. It can be difficult to make definitive conclusions on the most appropriate treatment options due to the variability in the outcomes used to define success in these articles. There is also a dire lack of studies evaluating and comparing the surgical options for patients with intrinsic sphincter deficiency.
Collapse
Affiliation(s)
- Anne P Cameron
- Department of Urology, Division of Neurourology and Pelvic Floor Reconstruction, University of Michigan Health System, Ann Arbor, MI, USA
| | - Allen McNeil Haraway
- Department of Urology, Division of Neurourology and Pelvic Floor Reconstruction, University of Michigan Health System, Ann Arbor, MI, USA
| |
Collapse
|
|
20
|
Lose G, Sørensen HC, Axelsen SM, Falconer C, Lobodasch K, Safwat T. An open multicenter study of polyacrylamide hydrogel (Bulkamid®) for female stress and mixed urinary incontinence. Int Urogynecol J 2010; 21:1471-7. [PMID: 20645077 PMCID: PMC2977052 DOI: 10.1007/s00192-010-1214-1] [Citation(s) in RCA: 42] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/28/2010] [Accepted: 06/22/2010] [Indexed: 11/24/2022]
Abstract
Introduction Polyacrylamide hydrogel (PAHG, Bulkamid®) is a promising urethral bulking agent. This multicenter study was carried out to evaluate safety and efficacy of Bulkamid® for female stress and mixed urinary incontinence. Methods Submucosal injection of Bulkamid® was performed in 135 women with urinary incontinence (stress, 67; mixed, 68) followed for 12 months. Forty-seven had a reinjection (35%). Results At 12 months, the subjective response rate was 66%. Incontinence episodes/24 h and urine leakage g/24 h decreased significantly (from 3.0 to 0.7 and 29 g to 4 g, respectively). Additionally, the median International Consultation on Incontinence Questionnaire score was reduced to approximately 50%, and the overall quality of life visual analogue scale score was decreased significantly (from 72 to 20). Efficacy was very similar between patients with stress and mixed incontinence. Thirty treatment-related adverse events were registered. The most frequent was urinary tract infection (n = 10). No polyacrylamide hydrogel-specific adverse events were seen. Conclusions Bulkamid® is an effective and safe bulking agent in women with stress or mixed incontinence.
Collapse
Affiliation(s)
- Gunnar Lose
- Department of Obstetrics and Gynaecology, Herlev County Hospital, University of Copenhagen, Herlev, Denmark.
| | | | | | | | | | | |
Collapse
|
|
21
|
Abstract
Synthetic polymeric microspheres find application in a wide range of medical applications. Among other applications, microspheres are being used as bulking agents, embolic- or drug-delivery particles. The exact composition of the spheres varies with the application and therefore a large array of materials has been used to produce microspheres. In this review, the relation between microsphere synthesis and application is discussed for a number of microspheres that are used for different treatment strategies.
Collapse
|
|
22
|
Durability of Urethral Bulking Agent Injection for Female Stress Urinary Incontinence: 2-Year Multicenter Study Results. J Urol 2010; 183:1444-9. [DOI: 10.1016/j.juro.2009.12.038] [Citation(s) in RCA: 52] [Impact Index Per Article: 3.5] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/14/2009] [Indexed: 11/22/2022]
|
|
23
|
Altman D, Anzén B, Mörlin B, Falconer C. Tension-free vaginal tape after failed cystoscopic transurethral injections for stress urinary incontinence. ACTA ACUST UNITED AC 2009; 43:506-8. [DOI: 10.3109/00365590903204021] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/13/2022]
Affiliation(s)
- Daniel Altman
- Department of Medical Epidemiology and Biostatistics, Karolinska Institutet,
- Division of Obstetrics and Gynecology, Department of Clinical Sciences, Karolinska Institutet at Danderyd Hospital, Stockholm, Sweden
| | - Bo Anzén
- Division of Obstetrics and Gynecology, Department of Clinical Sciences, Karolinska Institutet at Danderyd Hospital, Stockholm, Sweden
| | - Birgitta Mörlin
- Division of Obstetrics and Gynecology, Department of Clinical Sciences, Karolinska Institutet at Danderyd Hospital, Stockholm, Sweden
| | - Christian Falconer
- Division of Obstetrics and Gynecology, Department of Clinical Sciences, Karolinska Institutet at Danderyd Hospital, Stockholm, Sweden
| |
Collapse
|
|
24
|
Abstract
Stress urinary incontinence is a common health problem affecting women and interfering with their quality of life. The use of bulking agents for urethral augmentation seems to be a beneficial way of restoring continence in these patients while avoiding the risk of surgical intervention. Many agents are available for injection, but the ideal choice should be durable, nonmigratory, and hypoallergenic, while evoking healing with minimal scarring. We reviewed the literature to provide an update on the best techniques of bulking agent injection, to describe the different available injectable agents, and to give their outcome and possible complications.
Collapse
Affiliation(s)
- Ahmed F Kotb
- Department of Urology, Jewish General Hospital, 3755 Côte Sainte-Catherine, Montreal, Quebec QC H3E 1T2, Canada
| | | | | |
Collapse
|
|
25
|
Kuhn A. Long-term results and patients’ satisfaction after transurethral ethylene vinyl alcohol (Tegress®) injections: a two-centre study: reply to comment by Hurtado and Appell. Int Urogynecol J 2009. [DOI: 10.1007/s00192-008-0679-7] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/01/2022]
|
|
26
|
Cross-linked polydimethylsiloxane injection for female stress urinary incontinence: results of a multicenter, randomized, controlled, single-blind study. J Urol 2008; 181:204-10. [PMID: 19013613 DOI: 10.1016/j.juro.2008.09.032] [Citation(s) in RCA: 65] [Impact Index Per Article: 3.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/19/2008] [Indexed: 11/22/2022]
Abstract
PURPOSE In a pivotal trial we evaluated the effectiveness and safety of Macroplastique(R) as minimally invasive endoscopic treatment for female stress urinary incontinence primarily due to intrinsic sphincter deficiency. MATERIALS AND METHODS A total of 247 females with intrinsic sphincter deficiency were randomized 1:1 and treated with a transurethral injection of Macroplastique or Contigen. The latter group served as the control. Repeat treatment was allowed after the 3-month followup. Effectiveness was determined 12 months after the last treatment using Stamey grade, pad weight and Urinary Incontinence Quality of Life Scale scores. Safety assessment was recorded throughout the study. RESULTS After 12 patients were excluded from study 122 patients received Macroplastique injection and 125 received Contigen injection. Mean patient age was 61 years and the average history of incontinence was 11.2 years. Of the patients 24% had undergone prior incontinence surgery. At 12 months after treatment 61.5% of patients who received Macroplastique and 48% of controls had improved 1 Stamey grade. In the Macroplastique group the dry/cure rate was 36.9% compared to 24.8% in the control group (p <0.05). In the Macroplastique and control groups the 1-hour pad weight decrease was 25.4 and 22.8 ml from baseline (p = 0.64), and the mean improvement in Urinary Incontinence Quality of Life Scale score was 28.7 and 26.4 (p = 0.49), respectively. CONCLUSIONS Macroplastique injection was statistically more effective than Contigen for stress urinary incontinence primarily due to intrinsic sphincter deficiency with a 12.1% cure rate difference. Macroplastique can be administered on an outpatient basis. It should be considered a primary or secondary treatment option for stress urinary incontinence.
Collapse
|
|
27
|
Kuhn A. Adverse events of injectables, what kind of jet-skiers should be informed about serious vaginal injury, and what Kant thinks about it. Int Urogynecol J 2008; 19:1-2. [DOI: 10.1007/s00192-008-0672-1] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/02/2008] [Accepted: 06/02/2008] [Indexed: 11/28/2022]
|
|
28
|
Complications of Tegress injections. Int Urogynecol J 2008; 20:127; author reply 129. [PMID: 18604463 DOI: 10.1007/s00192-008-0674-z] [Citation(s) in RCA: 10] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/08/2008] [Accepted: 06/02/2008] [Indexed: 10/21/2022]
|
|
29
|
Kuhn A, Stadlmayr W, Sohail A, Monga A. Long-term results and patients' satisfaction after transurethral ethylene vinyl alcohol (Tegress) injections: a two-centre study. Int Urogynecol J 2007; 19:503-7. [PMID: 17955152 DOI: 10.1007/s00192-007-0479-5] [Citation(s) in RCA: 10] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/04/2007] [Accepted: 09/20/2007] [Indexed: 10/22/2022]
Abstract
Tegress is ethylene vinyl alcohol which is non-allergenic and permanent. The aim of the study was to evaluate efficacy, feasibility and safety of transurethral Tegress in women with urodynamic stress incontinence in a two-centre setting. Approximately 33 female patients with urodynamic stress incontinence were prospectively included in the study. Preoperatively, the patient's history, gynaecological examination and multichannel urodynamics were performed. On follow-up, the patient was asked to use a visual analogue scale to measure her contentness and underwent uroflowmetry and a cough test. Median follow up was 51 months. About 15 women considered themselves as completely continent, and 23 (69%) were either satisfied or very satisfied. Pad test was positive in 18 (54.5%) patients, and cough test was positive in 20 (60.6%). Patients' satisfaction did not correlate with objective dryness. Ethylene vinyl alcohol is a bulking agent with a success rate of approximately 45% after 51 months.
Collapse
|