Transvaginal mesh or grafts compared with native tissue repair for vaginal prolapse

Christopher Maher, Benjamin Feiner, Kaven Baessler, Corina Christmann-Schmid, Nir Haya, Jane Marjoribanks, Christopher Maher, Benjamin Feiner, Kaven Baessler, Corina Christmann-Schmid, Nir Haya, Jane Marjoribanks

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.

Conflict of interest statement

The lead review author, Christopher Maher, is an author of two trials of pelvic prolapse (Maher 2004a; Maher 2011)

The other review authors declare that they have no conflicts of interest.

Figures

Figure 1
Figure 1
PRISMA study flow diagram.
Figure 2
Figure 2
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Figure 3
Figure 3
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Figure 4
Figure 4
Forest plot of comparison: 1 Any transvaginal permanent mesh versus native tissue repair, outcome: 1.1 Awareness of prolapse (1 to 3 years).
Figure 5
Figure 5
Forest plot of comparison: 3 Biological repair versus native tissue repair, outcome: 3.1 Awareness of prolapse (1 to 3 years).
Figure 6
Figure 6
Funnel plot of comparison: 1 Any transvaginal permanent mesh versus native tissue repair, outcome: 1.3 Recurrent prolapse (any) at 1 to 3 years.
Analysis 1.1
Analysis 1.1
Comparison 1 Any transvaginal permanent mesh versus native tissue repair, Outcome 1 Awareness of prolapse (1‐3 years).
Analysis 1.2
Analysis 1.2
Comparison 1 Any transvaginal permanent mesh versus native tissue repair, Outcome 2 Repeat surgery (1‐3 years).
Analysis 1.3
Analysis 1.3
Comparison 1 Any transvaginal permanent mesh versus native tissue repair, Outcome 3 Recurrent prolapse (any) at 1‐3 years.
Analysis 1.4
Analysis 1.4
Comparison 1 Any transvaginal permanent mesh versus native tissue repair, Outcome 4 Injuries bladder or bowel.
Analysis 1.5
Analysis 1.5
Comparison 1 Any transvaginal permanent mesh versus native tissue repair, Outcome 5 Objective failure of anterior compartment (cystocoele).
Analysis 1.6
Analysis 1.6
Comparison 1 Any transvaginal permanent mesh versus native tissue repair, Outcome 6 Objective failure of posterior compartment (rectocoele).
Analysis 1.7
Analysis 1.7
Comparison 1 Any transvaginal permanent mesh versus native tissue repair, Outcome 7 POPQ assessment (any mesh).
Analysis 1.8
Analysis 1.8
Comparison 1 Any transvaginal permanent mesh versus native tissue repair, Outcome 8 Bladder function: de novo stress urinary incontinence (1‐3 years).
Analysis 1.9
Analysis 1.9
Comparison 1 Any transvaginal permanent mesh versus native tissue repair, Outcome 9 De novo voiding disorder, urgency, detrusor overactivity or overactive bladder.
Analysis 1.10
Analysis 1.10
Comparison 1 Any transvaginal permanent mesh versus native tissue repair, Outcome 10 De novo dyspareunia (1‐3 years).
Analysis 1.11
Analysis 1.11
Comparison 1 Any transvaginal permanent mesh versus native tissue repair, Outcome 11 Sexual function (1‐3 years).
Analysis 1.12
Analysis 1.12
Comparison 1 Any transvaginal permanent mesh versus native tissue repair, Outcome 12 Quality of life: continuous data (1‐2 years):.
Analysis 1.13
Analysis 1.13
Comparison 1 Any transvaginal permanent mesh versus native tissue repair, Outcome 13 Quality of life: dichotomous data "much or very much better".
Analysis 1.14
Analysis 1.14
Comparison 1 Any transvaginal permanent mesh versus native tissue repair, Outcome 14 Operating time (minutes).
Analysis 1.15
Analysis 1.15
Comparison 1 Any transvaginal permanent mesh versus native tissue repair, Outcome 15 Blood transfusion.
Analysis 1.16
Analysis 1.16
Comparison 1 Any transvaginal permanent mesh versus native tissue repair, Outcome 16 Length of stay in hospital (days).
Analysis 2.1
Analysis 2.1
Comparison 2 Absorbable mesh versus native tissue repair, Outcome 1 Awareness of prolapse (2 year review).
Analysis 2.2
Analysis 2.2
Comparison 2 Absorbable mesh versus native tissue repair, Outcome 2 Repeat surgery for prolapse (2 years).
Analysis 2.3
Analysis 2.3
Comparison 2 Absorbable mesh versus native tissue repair, Outcome 3 Recurrent prolapse (3 months ‐2 years).
Analysis 2.4
Analysis 2.4
Comparison 2 Absorbable mesh versus native tissue repair, Outcome 4 Death.
Analysis 2.5
Analysis 2.5
Comparison 2 Absorbable mesh versus native tissue repair, Outcome 5 Objective failure of anterior compartment (cystocoele).
Analysis 2.6
Analysis 2.6
Comparison 2 Absorbable mesh versus native tissue repair, Outcome 6 Objective failure of posterior compartment (rectocoele).
Analysis 2.7
Analysis 2.7
Comparison 2 Absorbable mesh versus native tissue repair, Outcome 7 Stress urinary incontinence.
Analysis 2.8
Analysis 2.8
Comparison 2 Absorbable mesh versus native tissue repair, Outcome 8 Quality of life (2 years).
Analysis 3.1
Analysis 3.1
Comparison 3 Biological repair versus native tissue repair, Outcome 1 Awareness of prolapse (1‐3 year).
Analysis 3.2
Analysis 3.2
Comparison 3 Biological repair versus native tissue repair, Outcome 2 Repeat prolapse surgery (1‐2 years).
Analysis 3.3
Analysis 3.3
Comparison 3 Biological repair versus native tissue repair, Outcome 3 Recurrent prolapse (1 year).
Analysis 3.4
Analysis 3.4
Comparison 3 Biological repair versus native tissue repair, Outcome 4 Injuries to bladder or bowel.
Analysis 3.5
Analysis 3.5
Comparison 3 Biological repair versus native tissue repair, Outcome 5 Objective failure of anterior compartment (cystocele).
Analysis 3.6
Analysis 3.6
Comparison 3 Biological repair versus native tissue repair, Outcome 6 Objective failure of posterior compartment (rectocele).
Analysis 3.7
Analysis 3.7
Comparison 3 Biological repair versus native tissue repair, Outcome 7 POPQ assessment.
Analysis 3.8
Analysis 3.8
Comparison 3 Biological repair versus native tissue repair, Outcome 8 De novo urinary stress incontinence.
Analysis 3.9
Analysis 3.9
Comparison 3 Biological repair versus native tissue repair, Outcome 9 De novo voiding disorders, urgency, detrusor overactivity or overactive bladder.
Analysis 3.10
Analysis 3.10
Comparison 3 Biological repair versus native tissue repair, Outcome 10 De novo dyspareunia (1 year).
Analysis 3.11
Analysis 3.11
Comparison 3 Biological repair versus native tissue repair, Outcome 11 Sexual function (1 year).
Analysis 3.12
Analysis 3.12
Comparison 3 Biological repair versus native tissue repair, Outcome 12 Quality of life (1 year).
Analysis 3.13
Analysis 3.13
Comparison 3 Biological repair versus native tissue repair, Outcome 13 Operating time (minutes).
Analysis 3.14
Analysis 3.14
Comparison 3 Biological repair versus native tissue repair, Outcome 14 Blood transfusion.

References

References to studies included in this review

    1. 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.
    1. Allahdin S, Glazener C, Bain C. A randomised controlled trial evaluating the use of polyglactin mesh, polydioxanone and polyglactin sutures for pelvic organ prolapse surgery. Journal of Obstetrics and Gynaecology 2008;28(4):427‐31.
    2. Madhuvrata P, Glazener C, Boachie C, Allahdin S, Bain C. A randomised controlled trial evaluating the use of polyglactin (Vicryl) mesh, polydioxanone (PDS) or polyglactin (Vicryl) sutures for pelvic organ prolapse surgery: outcomes at 2 years. Journal of Obstetrics and Gynaecology 2011;31(5):429‐35.
    1. Al‐Nazer MA, Ismail WA, Gomaa IA. Comparative study between anterior colporrhaphy versus vaginal wall repair with mesh for management of anterior vaginal wall prolapse (Abstract number 84). International Urogynecology Journal and Pelvic Floor Dysfunction 2007;18 Suppl 1:49‐50.
    2. El‐Nazer M, Gomaa I, Ismail Madkour W, Swidan K, El‐Etriby M. Anterior colporrhaphy versus repair with mesh for anterior vaginal wall prolapse: a comparative clinical study. Archives of Gynecology and Obstetrics 2012;286:965‐72.
    1. Altman D, Väyrynen T, Engh ME, Axelsen S, Falconer C, for the Nordic Transvaginal Mesh Group. Anterior colporrhaphy versus transvaginal mesh for pelvic‐organ prolapse. The New England Journal of Medicine 2011;364(19):1826‐36. [41463]
    2. Ek M, Altman D, Elmér C, Gunnarsson J, Falconer C, Tegerstedt G. Clinical efficacy of a trocar guided mesh kit for the repair of anterior lateral defects (Abstract number 556). Proceedings of the 41st Annual Meeting of the International Continence Society (ICS), 2011 Aug 29 to Sept 2, Glasgow, Scotland. 2011.
    3. Ek M, Tegerstedt G, Falconer C, Kjaeldgaard A, Rezapour M, Rudnicki M, et al. Urodynamic assessment of anterior vaginal wall surgery: A randomized comparison between colporrhaphy and transvaginal mesh. Neurourology and Urodynamics 2010;29:527‐31. [39589]
    1. Carey M, Higgs P, Goh J, Lim J, Leong A, Krause H, Cornish A. Vaginal repair with mesh versus colporrhaphy for prolapse: a randomised controlled trial. BJOG 2009;116(10):1380‐6. [32066]
    1. Dahlgren E, Kjolhede P on behalf of the RPOP‐PELVICOL Study Group. Long‐term outcome of porcine skin graft in surgical treatment of recurrent pelvic organ prolapse. An open randomized controlled multicenter study. Acta Obstetricia Et Gynecologica Scandinavica 2011;90:1393‐401.
    1. dos Reis Brandão da Silveira S, Haddad JM, Jármy‐Di Bella Z, Nastri F, Kawabata M, Silva Carramão S, et al. Multicenter, randomized trial comparing native vaginal tissue repair and synthetic mesh repair for genital prolapse surgical treatment. International Urogynecology Journal 2015;3:335‐42.
    1. Delroy CA, Castro Rde A, Dias MM, Feldner PC, Bortolini MA, Girao MS. The use of transvaginal synthetic mesh for anterior vaginal wall prolapse repair: a randomized controlled trial. International Urogynecology Journal 2013;24(11):1899‐907.
    1. Tayrac R, Mathe ML, Bader G, Deffieux X, Fazel A, Fernandez H. Infracoccygeal sacropexy or sacrospinous suspension for uterine or vaginal vault prolapse. International Journal of Gynaecology and Obstetrics 2008;100(2):154‐9.
    1. Tayrac R, Cornille A, Eglin G, Guilbaud O, Mansoor A, Alonso S, et al. Comparison between trans‐obturator trans‐vaginal mesh and traditional anterior colporrhaphy in the treatment of anterior vaginal wall prolapse: results of a French RCT. International Urogynecology Journal 2013;24:1651‐61.
    1. Feldner PC Jr, Castro RA, Cipolotti LA, Delroy CA, Sartori MG, Girao MJ. Anterior vaginal wall prolapse: a randomized controlled trial of SIS graft versus traditional colporrhaphy. International Urogynecology Journal and Pelvic Floor Dysfunction 2010;21(9):1057‐63. [40053]
    2. Feldner PC Jr, Castro RA, Delroy CA, Dias MM, Sartori MG, Girao MJ. Surgical treatment of anterior vaginal wall prolapse: comparison of small intestine submucosa (SIS) graft and traditional repair (Abstract number 160). International Urogynecology Journal 2009;20 Suppl 2:S208‐9. [39890]
    1. Gandhi S, Goldberg RP, Kwon C, Koduri S, Beaumont JL, Abramov Y, et al. A prospective randomized trial using solvent dehydrated fascia lata for the prevention of recurrent anterior vaginal wall prolapse. American Journal of Obstetrics and Gynecology 2005;192:1649‐54.
    2. Gandhi S, Kwon C, Goldberg RP, Abramov Y, Beaumont JL, Koduri S, et al. A randomized controlled trial of fascia lata for the prevention of recurrent anterior vaginal wall prolapse. Neurourology and Urodynamics 2004;23(5/6):558.
    3. Kwon C, Goldberg R, Evaston IL, Koduri S, Franklin WI, Gandhi S, et al. Preliminary results of a prospective randomized trial of tutoplast processed fascia lata to prevent recurrent cystoceles and rectoceles. The Journal of Urology 2002;167:203.
    1. Guerette NL, Aguirre O, VanDrie DM, Biller DH, Davila GW. Multi‐center, randomized, prospective trial comparing anterior colporrhaphy alone to bovine pericardium collagen matrix graft reinforced anterior colporrhaphy: 12‐month analysis (Abstract number 11). International Urogynecology Journal and Pelvic Floor Dysfunction 2006;17 Suppl 2:63‐4.
    2. Guerette NL, Peterson TV, Aguirre OA, VanDrie DM, Biller DH, Davila GW. Anterior repair with or without collagen. Obstetrics and Gynecology 2009;114:59‐65.
    1. Gupta B, Vaid NB, Suneja A, Guleria K, Jain S. Anterior vaginal prolapse repair: A randomised trial of traditional anterior colporrhaphy and self‐tailored mesh repair. South African Journal of Obstetrics and Gynaecology 2014;20(3):47‐50.
    1. Halaska M, Maxova K, Sottner O, Svabik K, Mlcoch M, Kolarik D, et al. A multicentre randomized prospective controlled study comparing sacrospinous fixation and transvaginal mesh in the treatment of post‐hysterectomy vaginal vault prolapse. American Journal of Obstetrics and Gynecology 2012;207(301):e1‐7.
    1. Hviid U, Hviid TV, Rudnicki M. Porcine skin collagen implants for anterior vaginal wall prolapse: a randomised prospective controlled study. International Urogynecology Journal 2010;21(5):529‐34. [39449]
    1. Gutman R, Nosti P, Sokol A, Sokol E, Peterson J, Wang H, Iglesia C. Three‐year outcome of vaginal mesh for prolapse, a randomized controlled trial. Obstetrics & Gynecology 2013;122(4):770‐7. [: NCT00475540]
    2. Iglesia CB, Sokol AI, Sokol ER, Kudish BI. Vaginal mesh for prolapse: a randomized controlled trial. Obstetrics and Gynecology 2010;116(2 Pt 1):293‐303. [39891]
    3. Sokol AI, Iglesia CB, Kudish BI, Gutman RE, Shveiky D, Bercik R, et al. One‐year objective and functional outcomes of a randomized clinical trial of vaginal mesh for prolapse. American Journal of Obstetrics and Gynecology 2012;206(1):86.e1‐9. [DOI: 10.1016/j.ajog.2011.08.003; 42158]
    1. Lamblin G, Van‐Nieuwenhuyse A, Chabert P, Lebail‐Carval K, Moret S, Mellier G. A randomized controlled trial comparing anatomical and functional outcome between vaginal colposuspension and transvaginal mesh. International Urogynecology Journal 2014;25:961–70.
    1. Dyer K, Nguyen J, Lukacz E, Simsiman A, Luber K, Menefee S. The Optimal Anterior Repair Study (OARS): a triple arm randomized double blinded clinical trial of standard colporrhaphy, porcine dermis or polypropylene mesh augmented anterior vaginal wall repair (Abstract number 252). Neurourology and Urodynamics 2009;28(7):894‐5. [39346]
    2. Dyer K, Nguyen J, Simsiman A, Lukacz E, Luber K, Menefee S. The Optimal Anterior Repair Study (OARS): a triple arm randomized double blinded clinical trial of standard colporrhaphy versus vaginal paravaginal repair with porcine dermis graft or polypropylene mesh (Abstract number 281). Neurourology and Urodynamics 2010;29(6):1207‐8. [40164]
    3. Menefee SA, Dyer KY, Lukacz ES, Simsiman AJ, Luber KM, Nguyen JN. Colporrhaphy compared with mesh or graft‐reinforced vaginal paravaginal repair for anterior vaginal wall prolapse: a randomized controlled trial. Obstetrics and Gynecology 2011;118(6):1337‐44. [42866]
    1. 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). Proceedings of the Joint Meeting of the International Continence Society (34th Annual Meeting) and the International Urogynecological Association, 2004 Aug 23‐27, Paris. 2004.
    1. Kocjancic E, Crivellaro S, Bernasconi F, Magatti F, Frea B, Meschia M. A two years follow‐up, prospective randomized study on cystocele repair with or without Pelvicol (trademark) implant (Abstract number 1374). Proceedings of the Annual Meeting of the American Urological Association, 19‐24 May 2007, Anaheim (CA). 2007.
    2. Meschia M, Pifarotti P, Bernasconi F, Magatti F, Riva D, Kojancic E. Porcine skin collagen implants to prevent anterior vaginal wall prolapse recurrence: A multicentre, randomized study. The Journal of Urology 2007;177:192‐5.
    3. Meschia M, Pifarotti P, Magatti F, Bernasconi F, Riva D, Kojancic E. Porcine skin collagen implants (Pelvicol) (trademark) to prevent anterior vaginal wall prolapse recurrence: a randomized study (Abstract). Neurourology and Urodynamics 2005;24(5/6):587‐8.
    1. Nguyen JN, Burchette RJ. Anatomy and visceral function after anterior vaginal prolapse repair: a randomized controlled trial (Abstract number 42). Proceedings of the 29th Annual Meeting of the American Urogynecologic Society (AUGS), Sept 4‐6, Chicago. 2008.
    2. Nguyen JN, Burchette RJ. Outcome after anterior vaginal prolapse repair. Randomized controlled trial. Obstetrics and Gynecology 2008;111(4):891‐8.
    1. Hiltunen R, Nieminen K, Takala T, Heiskanen E, Merikari M, Niemi K, et al. Low‐weight polypropylene mesh for anterior vaginal wall prolapse: a randomized controlled trial. Obstetrics and Gynecology 2007;110(2 pt 2):455‐62.
    2. Nieminen K, Hiltunen R, Heiskanen E, Takala T, Niemi K, Merikari M, et al. Symptom resolution and sexual function after anterior vaginal wall repair with or without polypropylene mesh. International Urogynecology Journal. 2008;19(12):1611‐6.
    3. Nieminen K, Hiltunen R, Takala T, Heiskanen E, Merikari M, Niemi K, et al. Outcomes after anterior vaginal wall repair with mesh: a randomized, controlled trial with a 3 year follow‐up. American Journal of Obstetrics and Gynecology 2010;203(3):235.e1‐8. [40020]
    1. Paraiso M, Barber M, Muir T, Walters M. Rectocele repair: A randomized trial of three surgical techniques including graft augmentation. American Journal of Obstetrics and Gynecology 2006;195:1762‐71.
    1. Qatawneh A, Al‐Kazaleh F, Saleh S, Thekrallah F, Bata M, Sumreen I, et al. Transvaginal cystocele repair using tension‐free polypropylene mesh at the time of sacrospinous colpopexy for advanced uterovaginal prolapse: a prospective randomised study. Gynecological Surgery 2013;10:79‐85.
    1. Robert M, Girard I, Brennand E, Tang S, Birch C, Murphy M, et al. Absorbable mesh augmentation compared with no mesh for anterior prolapse: a randomized controlled trial. Obstetrics and Gynecology 2014;123(2 Part 1):288‐94.
    1. Rudnicki M, Laurikainen E, Pogosean R, Kinne I, Jakobsson U, Teleman P. A 3–year follow‐up after anterior colporrhaphy compared with collagen‐coated transvaginal mesh for anterior vaginal wall prolapse: a randomised controlled trial. BJOG 2015;published online:1‐7.
    2. Rudnicki M, Laurikainen E, Pogosean R, Kinne I, Jakobsson U, Teleman P. Anterior colporrhaphy compared with collagen‐coated transvaginal mesh for anterior vaginal wall prolapse: a randomised controlled trial. BJOG 2014;121:102‐11.
    1. Goldberg RP, Koduri S, Lobel RW, Culligan PJ, Tomezsko JE, Winkler HA, et al. Long‐term effects of three different anti‐incontinence procedures on the posterior compartment (Abstract). Proceedings of the International Continence Society (ICS) 31st Annual Meeting; 2001 Sept 18‐21; Seoul, Korea. 2001.
    2. Sand PK, Koduri S, Lobel RW, Winkler HA, Tomezsko J, Culligan PJ, et al. Prospective randomized trial of polyglactin 910 mesh to prevent recurrence of cystoceles and rectoceles. American Journal of Obstetrics and Gynecology 2001;184(7):1357‐64.
    1. Sivaslioglu AA, Unlubilgin E, Dolen I. A randomized comparison of polypropylene mesh surgery with site‐specific surgery in the treatment of cystocoele. International Urogynecology Journal. 2008;19(4):467‐71.
    1. Sung VW, Rardin CR, Raker CA, Lasala CA, Myers DL. Porcine subintestinal submucosal graft augmentation for rectocele repair: a randomized controlled trial. Obstetrics and Gynecology 2012;119(1):125‐33. [42876]
    1. Svabik K, Martan A, Masata J, El‐Haddad R, Hubka P. Comparison of vaginal mesh repair with sacrospinous vaginal colpopexy in the management of vaginal vault prolapse after hysterectomy in patients with levator ani avulsion: a randomized controlled trial. Ultrasound in Obstetrics and Gynecology 2014;43(4):365‐71.
    1. Tamanini JTN, Oliveira Souza Castro RC, Tamanini JM, Castro RA, Sartori MGF, Girão MJBC. A prospective, randomized and controlled trial for the treatment of anterior vaginal wall prolapse: medium‐term follow‐up. The Journal of Urology 2015;193(4):1298‐304.
    2. Tamanini JTN, Oliveira Souza Castro RC, Tamanini JM, Castro RA, Sartori MGF, Girão MJBC. Treatment of anterior vaginal wall prolapse with and without polypropylene mesh: a prospective, randomized and controlled trial ‐ Part I. Int Braz J Urol 2013;39(4):519‐30.
    1. Thijs S, Deprest J, Ridder D, Claerhout F, Roovers J. A randomized controlled trial of anterior colporraphy and Perigee™ as a primary surgical correction of symptomatic cystocele (Abstract number 96). International Urogynecology Journal and Pelvic Floor Dysfunction 2010;21 Suppl 1:S142‐3. [40133]
    1. Turgal M, Sivaslioglu A, Yildiz A, Dolen I. Anatomical and functional assessment of anterior colporrhaphy versus polypropylene mesh surgery in cystocele treatment. European Journal of Obstetrics and Gynecology and Reproductive Biology 2013;170(2):555‐8.
    1. Vollebregt A, Fischer K, Gietelink D, Vaart CH. Primary surgical repair of anterior vaginal prolapse: a randomised trial comparing anatomical and functional outcome between anterior colporrhaphy and trocar‐guided transobturator anterior mesh. British Journal of Obstetrics and Gynaecology 2011;118(12):1518‐27. [42606]
    2. Vollebregt A, Gietelink D, Fischer K, Vaart H. One year results of colporrhaphy anterior versus a trocar guided transobturator synthetic mesh in primary cystocele repair: a randomized controlled trial (Abstract number 51). Neurourology and Urodynamics 2010;29(6):880‐2. [40124]
    1. Weber AM, Walters MD, Piedmonte MR, Ballard LA. Anterior colporrhaphy: a randomized trial of three surgical techniques. American Journal of Obstetrics and Gynecology 2001;185(6 Pt 1):1299‐306.
    1. Milani AL, Withagen MI, The HS, Nedelcu‐Van der Wijk I, Vierhout ME. Sexual function following trocar‐guided mesh or vaginal native tissue repair in recurrent prolapse: A randomized controlled trial. The Journal of Sexual Medicine 2011;8(10):2944‐53. [42064]
    2. 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]
    3. Withagen MI, Milani AL, 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]
References to studies excluded from this review
    1. 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.
    1. 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.
    1. 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.
    1. 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). Proceedings of the Joint Meeting of the International Continence Society (ICS) and the International Urogynecological Association, 2010 Aug 23‐27, Toronto, Canada. 2010.
    1. 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.
    2. 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). Proceedings of the International Continence Society, 11th Annual Scientific Meeting; 2004 Mar 18‐19; Bournemouth, United Kingdom. 2004:46. [17170]
References to ongoing studies
    1. ACTRN12612000236897. Puborectalis sling RCT ‐ a study on reducing pelvic organ prolapse recurrences following prolapse surgery. (accessed 24/2/2012).
    1. ISRCTN60695184. Clinical 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 (PROSPECT). (accessed 13 April 2010).
    1. NCT00743535. Anterior defect correction with mesh plus treatment of stress incontinence with transobturator or transvaginal approach. (accessed April 2013).
    1. NCT00955448. Trial of small intestine submucosa (SIS) mesh for anterior repair. (accessed August 2013).
    1. NCT01095692. Evaluating the necessity of TOT implantation in women with pelvic organ prolapse and occult stress urinary incontinence (ATHENA). (accessed 19 April 2011). [41350]
    1. NCT01097200. Sacrocolpopexy versus vaginal mesh procedure for pelvic prolapse (Elevate). (accessed May 2015).
    1. NCT01497171. The ELEGANT Trial: Elevate transvaginal mesh vs. anterior colporrhaphy. (accessed 2011).
    1. NCT01594372. Comparison laparoscopic to vaginal surgery for uterine prolapse. (accessed 2012).
    1. NCT01637441. Prosthetic Pelvic Organ Prolapse Repair (PROSPERE). (accessed 2012).
    1. NCT01762384. Laparoscopic sacral colpopexy versus modified total pelvic floor reconstructive surgery for apical prolapse stage III‐IV. (accessed 2012).
    1. NCT01802281. Study of uterine prolapse procedures ‐ randomized trial (SUPeR). (last accessed July 2015).
    1. NTR1197. Concomitant surgery and urodynamic investigation in genital prolapse and stress incontinence. A diagnostic study including outcome evaluation. CUPIDO 1: Vaginal prolapse repair and mid urethral sling procedure in women with genital prolapse and predominant stress urinary incontinence. (accessed June 2012). [34193]
    2. Steen A, Ploeg M, Dijkgraaf MG, V, Roovers JP. Protocol for the CUPIDO trials; multicenter randomized controlled trials to assess the value of combining prolapse surgery and incontinence surgery in patients with genital prolapse and evident stress incontinence (CUPIDO I) and in patients with genital prolapse and occult stress incontinence (CUPIDO II). BMC Women's Health 2010;10:16. [39877]
Additional references
    1. Accident Compenstaion Corporation (ACC). Surgical Mesh Review: Analysis of Treatment Injury Claims 1 July 2005 to 30 June 2014. 2015.
    1. Adams E, Thomson A, Maher C, Hagen S. Mechanical devices for pelvic organ prolapse in women. Cochrane Database of Systematic Reviews 2004, Issue 2. [DOI: 10.1002/14651858.CD004010.pub2]
    1. Brubaker L, Bump R, Jacquetin B, Schuessler B, Weidner A, Zimmern P, et al. Pelvic organ prolapse. Incontinence: 2nd International Consultation on Incontinence. 2nd Edition. Plymouth: Health Publication Ltd, 2002:243‐65.
    1. Bump R, Norton P. Epidemiology and natural history of pelvic floor dysfunction. Obstetrics and Gynecology Clinics of North America 1998;25(4):723‐46. [MEDLINE: ]
    1. Cohen J. Statistical Power Analysis for the Behavioral Sciences. 2nd Edition. Lawrence Erlbaum Associates, 1988.
    1. Ek M, Tegerstedt G, Falconer C, Kjaeldgaard A, Rezapour M, Rudnicki M, et al. Urodynamic assessment of anterior vaginal wall surgery: A randomized comparison between colporraphy and transvaginal mesh. Neurourology and Urodynamics 2010;29:527‐31. [39589]
    1. Ek M, Altman D, Elmér C, Gunnarsson J, Falconer C, Tegerstedt G. Clinical efficacy of a trocar guided mesh kit for the repair of anterior lateral defects (Abstract number 556). Proceedings of the 41st Annual Meeting of the International Continence Society (ICS), 2011 Aug 29 to Sept 2, Glasgow, Scotland. 2011.
    1. Fatton B, Amblard J, Debodinance P, Cosson M, Jacqutin B. Transvaginal repair of genital prolapse: preliminary results of a new tension‐free vaginal mesh (Prolift technique) ‐ a case series multicentric study. International Urogynecology Journal and Pelvic Floor Dysfunction 2007;18:743–52.
    1. Food, Drug Administration (FDA). Surgical mesh for POP and SUI repair: FDA executive summary. (accessed 8‐9 September 2011).
    1. Ford AA, Rogerson L, Cody JD, Ogah J. Mid‐urethral sling operations for stress urinary incontinence in women. Cochrane Database of Systematic Reviews 2015, Issue 7. [DOI: 10.1002/14651858.CD006375.pub3]
    1. Gill EJ, Hurt WG. Pathophysiology of pelvic organ prolapse. Obstetrics and Gynecology Clinics of North America 1998;25(4):759‐69. [MEDLINE: ]
    1. GRADEpro 2014. [Computer program on ]. McMaster University, Version December 2015.
    1. Gutman R, Nosti P, Sokol A, Sokol E, Peterson J, Wang H, et al. Three‐year outcome of vaginal mesh for prolapse, a randomized controlled trial. Obstetrics & Gynecology 2013;122(4):770‐7. [: NCT00475540]
    1. Hagen S, Stark D. Conservative prevention and management of pelvic organ prolapse in women. Cochrane Database of Systematic Reviews 2011, Issue 12. [DOI: 10.1002/14651858.CD003882.pub4]
    1. Handa VL, Garrett E, Hendrix S, Gold E, Robbins J. Progression and remission of pelvic organ prolapse: a longitudinal study of menopausal women. American Journal of Obstetrics and Gynecology 2004;190(1):27‐32.
    1. Haya N, Baessler K, Christmann‐Schmid C, Tayrac R, Dietz V, Guldberg R, et al. Prolapse and continence surgery in countries of the Organization for Economic Co‐operation and Development in 2012. American Journal of Obstetrics and Gynecology 2015;212(6):755‐7.
    1. Hendrix SL, Clark A, Nygaard I, Aragaki A, Barnabei V, McTiernan A. Pelvic organ prolapse in the Women's Health Initiative: gravity and gravidity. American Journal of Obstetrics and Gynecology 2002;186(6):1160‐6.
    1. Higgins JPT, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta‐analyses. BMJ 2003;327:557‐60.
    1. Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. .
    1. Kohli N, Miklos JR. Dermal graft‐augmented rectocele repair. Int Urogynecol J Pelvic Floor Dysfunct 2003;14:146‐9.
    1. MacLennan AH, Taylor AW, Wilson DH, Wilson D. The prevalence of pelvic floor disorders and their relationship to gender, age, parity and mode of delivery. British Journal of Obstetrics and Gynaecology 2000;107(12):1460‐70. [MEDLINE: ]
    1. Maher CF, Qatawneh AM, Dwyer PL, Carey MP, Cornish A, Schluter PJ. Abdominal sacral colpopexy or vaginal sacrospinous colpopexy for vaginal vault prolapse: A prospective randomized study. American Journal of Obstetrics and Gynecology 2004;190(1):20‐6.
    1. Maher CF, Feiner B, Decuyper EM, Nichlos CJ, Hickey KV, O'Rourke P. Laparoscopic sacral colpopexy versus total vaginal mesh for vaginal vault prolapse: a randomized trial. American Journal of Obstetrics and Gynecology 2011;204(4):e361‐7.
    1. Medicines and Healthcare Products Regulatory Agency (MHRA). A summary of the evidence on the benefits and risks of vaginal mesh implants. (Accessed Oct 2014).
    1. Milani AL, Withagen MI, The HS, Nedelcu‐Van der Wijk I, Vierhout ME. Sexual function following trocar‐guided mesh or vaginal native tissue repair in recurrent prolapse: A randomized controlled trial. The Journal of Sexual Medicine 2011;8(10):2944‐53. [42064]
    1. Epstein M, Emri I, Hartemann P, Hoet P, Leitgeb N, Martínez Martínez L, et al. The safety of surgical meshes used in urogynecological surgery. 3 December 2015, issue .
References to other published versions of this review
    1. Maher C, Baessler K, Glazener CMA, Adams EJ, Hagen S. Surgical management of pelvic organ prolapse in women. Cochrane Database of Systematic Reviews 2004, Issue 4. [DOI: 10.1002/14651858.CD004014.pub2]

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