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Meta-Analysis
. 2016 Feb 9;2(2):CD012079.
doi: 10.1002/14651858.CD012079.

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

Christopher Maher  1 , Benjamin Feiner, Kaven Baessler, Corina Christmann-Schmid, Nir Haya, Jane Marjoribanks
Affiliations
Meta-Analysis

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

Christopher Maher et al. Cochrane Database Syst Rev. .

Update in

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.

PubMed Disclaimer

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

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

References to studies included in this review

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Turgal 2013 {published data only}
    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. - PubMed
Vollebregt 2011 {published data only}
    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] - PubMed
    1. 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]
Weber 2001 {published data only}
    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. - PubMed
Withagen 2011 {published and unpublished data}
    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] - PubMed
    1. 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]
    1. 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] - PubMed

References to studies excluded from this review

Altman 2013 {published data only}
    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.
Balci 2011 {published data only}
    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. - PubMed
Chao 2012 {published data only}
    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. - PubMed
Juneja 2010 {published data only}
    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.
Tincello 2009 {published data only}
    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. - PubMed
    1. 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

ACTRN12612000236897 {unpublished data only}
    1. ACTRN12612000236897. Puborectalis sling RCT ‐ a study on reducing pelvic organ prolapse recurrences following prolapse surgery. http://www.anzctr.org.au/ACTRN12612000236897.aspx (accessed 24/2/2012).
ISRCTN60695184 {published data only}
    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). www.controlled‐trials.com/ISRCTN60695184 (accessed 13 April 2010). - PMC - PubMed
NCT00743535 {published data only}
    1. NCT00743535. Anterior defect correction with mesh plus treatment of stress incontinence with transobturator or transvaginal approach. http://ClinicalTrials.gov/show/NCT00743535 (accessed April 2013).
NCT00955448 {published data only}
    1. NCT00955448. Trial of small intestine submucosa (SIS) mesh for anterior repair. https://clinicaltrials.gov/show/NCT00955448 (accessed August 2013).
NCT01095692 {published data only}
    1. 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 (accessed 19 April 2011). [41350]
NCT01097200 {published data only}
    1. NCT01097200. Sacrocolpopexy versus vaginal mesh procedure for pelvic prolapse (Elevate). https://clinicaltrials.gov/show/NCT01097200 (accessed May 2015).
NCT01497171 {unpublished data only}
    1. NCT01497171. The ELEGANT Trial: Elevate transvaginal mesh vs. anterior colporrhaphy. http://ClinicalTrials.gov/show/NCT01497171 (accessed 2011).
NCT01594372 {unpublished data only}
    1. NCT01594372. Comparison laparoscopic to vaginal surgery for uterine prolapse. http://ClinicalTrials.gov/show/NCT01594372 (accessed 2012).
NCT01637441 {unpublished data only}
    1. NCT01637441. Prosthetic Pelvic Organ Prolapse Repair (PROSPERE). https://clinicaltrials.gov/show/NCT01637441 (accessed 2012).
NCT01762384 {published data only}
    1. NCT01762384. Laparoscopic sacral colpopexy versus modified total pelvic floor reconstructive surgery for apical prolapse stage III‐IV. https://clinicaltrials.gov/show/NCT01762384 (accessed 2012).
NCT01802281 {unpublished data only}
    1. NCT01802281. Study of uterine prolapse procedures ‐ randomized trial (SUPeR). https://clinicaltrials.gov/show/NCT01802281 (last accessed July 2015).
NTR1197 {published data only}
    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. Netherlands Trial Register. http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1197 (accessed June 2012). [34193]
    1. 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] - PMC - PubMed

Additional references

ACC 2015
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Adams 2004
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Brubaker 2002
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Bump 1998
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Ek 2010
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Ek 2011
    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.
Fatton 2007
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Gutman 2013
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Hagen 2011
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Handa 2004
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Haya 2015
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Maher 2004a
    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. - PubMed
Maher 2011
    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. - PubMed
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Milani 2011
    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] - PubMed
SCENHIR 2015
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References to other published versions of this review

Maher 2004
    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] - DOI - PubMed

Publication types