Transvaginal mesh or grafts or native tissue repair for vaginal prolapse
- PMID: 38477494
- PMCID: PMC10936147
- DOI: 10.1002/14651858.CD012079.pub2
Transvaginal mesh or grafts or native tissue repair for vaginal prolapse
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.
Trial registration: ClinicalTrials.gov NCT00566917 NCT001532257 NCT00321867 NCT01095692.
Copyright © 2024 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Conflict of interest statement
EY, KB, CC, NH, ZC, SW, AM, and CM have no conflicts of interests to declare
Figures
Update of
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Transvaginal mesh or grafts compared with native tissue repair for vaginal prolapse.Cochrane Database Syst Rev. 2016 Feb 9;2(2):CD012079. doi: 10.1002/14651858.CD012079. Cochrane Database Syst Rev. 2016. Update in: Cochrane Database Syst Rev. 2024 Mar 13;3:CD012079. doi: 10.1002/14651858.CD012079.pub2. PMID: 26858090 Free PMC article. Updated.
References
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- Withagen MI, Milani AL, Boon Den J, Vervest HA, Vierhout ME. Tension free vaginal mesh compared to conventional vaginal prolapse surgery in recurrent prolapse; a randomized controlled trial (Abstract number 090). International Urogynaecology Journal 2009;20 Suppl 2:S153-4. [39885]
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- Withagen MI, Milani AL, den Boon J, Vervest HA, Vierhout ME. Trocar-guided mesh compared with conventional vaginal repair in recurrent prolapse: a randomized controlled trial. Obstetrics and Gynecology 2011;117(2 Pt 1):242-50. [40881] - PubMed
Yang 2016 {published data only}
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- Yang X-H, Zhao Z-Y. Prolift mesh versus polypropylene mesh in the whole pelvic floor reconstruction. Chinese Journal of Tissue Engineering Research 2016;20(34):5122-8.
References to studies excluded from this review
Ali 2006 {published data only}
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- Ali S, Han HC, Lee LC. A prospective randomized trial using Gynemesh PS (trademark) for the repair of anterior vaginal wall prolapse (Abstract number 292). International Urogynecology Journal and Pelvic Floor Dysfunction 2006;17 Suppl 2:221.
Altman 2013 {published data only}
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- Altman D, Mooller Bek K, Mikkola T, Gunnarsson J, Ellstrom Engh M, Falconer C. Intra-and perioperative morbidity following pelvic organ prolapse repair using a transvaginal suture capturing mesh device compared to trocar guided transvaginal mesh and traditional colporraphy. Neurourology and Urodynamics 2013;32(6):873-4.
Balci 2011 {published data only}
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- Balci O, Capar M, Acar A, Colakoglu MC. Balci technique for suspending vaginal vault at vaginal hysterectomy with reduced risk of vaginal vault prolapse. Journal of Obstetrics and Gynaecology Research 2011;37(7):762-9. - PubMed
Chao 2012 {published data only}
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- Chao FL, Rosamilia A, Dwyer PL, Polyakov A, Schierlitz L, Agnew G. Does pre-operative traction on the cervix approximate intra-operative uterine prolapse? A randomised controlled trial. International Urogynecology Journal 2012;23(4):417-22. - PubMed
Juneja 2010 {published data only}
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- Juneja M, Munday D, Kopetz V, Barry C. Hysterectomy vs no hysterectomy for uterine prolapse in conjunction with posterior infracococcygeal colpopexy - a randomised pilot study 12 months review (Abstract number 692). In: Proceedings of the Joint Meeting of the International Continence Society (ICS) and the International Urogynecological Association, 2010 Aug 23-27, Toronto, Canada. 2010.
Lukacz 2020 {published data only}
Meschia 2004 {published and unpublished data}
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- Meschia M, Gattei U, Pifarotti P, Spennacchio M, Longatti D, Barbacini P. Randomized comparison between infracoccygeal sacropexy (posterior IVS) and sacrospinous fixation in the management of vault prolapse (Abstract number 614). In: Proceedings of the Joint Meeting of the International Continence Society (34th Annual Meeting) and the International Urogynecological Association, 2004 Aug 23-27, Paris. 2004.
NCT00743535 {published data only}
-
- NCT00743535. Anterior defect correction with mesh plus treatment of stress incontinence with transobturator or transvaginal approach. http://ClinicalTrials.gov/show/NCT00743535 (first posted 28 August 2008).
NCT01497171 {unpublished data only}
-
- NCT01497171. The ELEGANT Trial: Elevate transvaginal mesh vs. anterior colporrhaphy. http://ClinicalTrials.gov/show/NCT01497171 (first posted 20 December 2011).
NCT01594372 {unpublished data only}
-
- NCT01594372. Comparison laparoscopic to vaginal surgery for uterine prolapse. http://ClinicalTrials.gov/show/NCT01594372 (first posted 4 May 2012).
Reid 2021 {published data only}
-
- Reid FM, Elders A, Breeman S, Freeman RM, Prospect study group. How common are complications following polypropylene mesh, biological xenograft and native tissue surgery for pelvic organ prolapse? A secondary analysis from the PROSPECT trial. BJOG 2021;128(13):2180-2189. [DOI: 10.1111/1471-0528.16897] - DOI - PMC - PubMed
Tincello 2009 {published data only}
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- Tincello DG, Kenyon S, Slack M, Toozs-Hobson P, Mayne C, Jones D, et al. Colposuspension or TVT with anterior repair for urinary incontinence and prolapse: results of and lessons from a pilot randomised patient-preference study (CARPET 1). British Journal of Obstetrics and Gynaecology 2009;116(13):1809-14. - PubMed
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- Tincello DG, Mayne CJ, Toozs-Hobson P, Slack M. Randomised controlled trial of colposuspension versus anterior repair plus TVT for urodynamic stress incontinence with anterior vaginal prolapse: proposal (Abstract). In: Proceedings of the International Continence Society, 11th Annual Scientific Meeting; 2004 Mar 18-19; Bournemouth, United Kingdom. 2004:46. [17170]
Wallace 2021 {published data only}
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- Wallace S, Syan R, Lee K, Sokol E. Cost-effectiveness of transvaginal hysteropexy compared to vaginal hysterectomy with apical suspension for the treatment of pelvic organ prolapse: a 5-year markov model. Neurourology and Urodynamics 202140;40(SUPPL 1):S65-7.
References to ongoing studies
NCT00955448 {published data only}
-
- NCT00955448. Trial of small intestine submucosa (SIS) mesh for anterior repair. https://clinicaltrials.gov/show/NCT00955448 (first posted 5 August 2009).
NCT01095692 {published data only}
-
- NCT01095692. Evaluating the necessity of TOT implantation in women with pelvic organ prolapse and occult stress urinary incontinence (ATHENA). http://clinicaltrials.gov/ct2/show/NCT01095692 (first posted 29 March 2010). [41350]
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Miklos 2016
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References to other published versions of this review
Maher 2004b
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