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Randomized Controlled Trial
. 2010 Aug;116(2 Pt 1):293-303.
doi: 10.1097/AOG.0b013e3181e7d7f8.

Vaginal mesh for prolapse: a randomized controlled trial

Cheryl B Iglesia  1 , Andrew I Sokol, Eric R Sokol, Bela I Kudish, Robert E Gutman, Joanna L Peterson, Susan Shott
Affiliations
Randomized Controlled Trial

Vaginal mesh for prolapse: a randomized controlled trial

Cheryl B Iglesia et al. Obstet Gynecol. 2010 Aug.

Abstract

Objective: To present 3-month outcomes of a double-blind, multicenter randomized controlled trial comparing traditional vaginal prolapse surgery without mesh with vaginal surgery with mesh.

Methods: Women with pelvic organ prolapse quantification prolapse stages 2-4 were randomized to vaginal colpopexy repair with mesh or traditional vaginal colpopexy without mesh. The primary outcome measure was objective treatment success (pelvic organ prolapse quantification stage 1 or lower) at 3 months. Secondary outcome measures included quality-of-life variables and complication rates.

Results: Sixty-five women were recruited from January 2007 to August 2009, when the study was halted due to predetermined stopping criteria for vaginal mesh erosion at a median follow-up of 9.7 months (range, 2.4-26.7 months). Thirty-two women underwent mesh colpopexy (24 anterior mesh, eight total mesh), and 33 women had vaginal colpopexies without mesh (primarily uterosacral ligament suspension) and concurrent colporrhaphy. There were no statistically significant baseline differences between the mesh and no-mesh groups with respect to demographics, menopausal status, and race. Analysis of the mesh and no-mesh women found no difference with respect to overall recurrence (mesh: 19 [59.4%] compared with no mesh: 24 [70.4%], P=.28). There were five (15.6%) vaginal mesh erosions. Two cystotomies and one blood transfusion occurred in the mesh group only. Subjective cure of bulge symptoms was noted in 93.3% of mesh patients and 100% of no-mesh patients. Furthermore, subjective quality-of-life measurements did not differ between the two groups at baseline or 3 months postoperatively.

Conclusion: At 3 months, there is a high vaginal mesh erosion rate (15.6%) with no difference in overall objective and subjective cure rates. This study questions the value of additive synthetic polypropylene mesh for vaginal prolapse repairs.

Clinical trial registration: Clinicaltrials.gov, www.clinicaltrials.gov, NCT00475540.

Level of evidence: I.

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References

    1. Jia X, Glazener C, Mowatt G, MacLennan G, Bain C, Fraser C, et al. Efficacy and safety of using mesh or grafts in surgery for anterior and/or posterior vaginal wall prolapse; systematic review and meta-analysis. BJOG 2008;115:1350–61.
    1. Feiner B, Jelovsek JE, Maher C. Efficacy and safety of transvaginal mesh kits in the treatment of prolapse of the vaginal apex: a systematic review. BJOG 2009;116:15–24.
    1. Sung VW, Rogers RG, Schaffer JI, Balk EM, Uhlig K, Lau J, et al. Graft use in transvaginal pelvic organ prolapse repair: a systematic review. Obstet Gynecol 2008;112:1131–42.
    1. Diwadkar GB, Barber MD, Feiner B, Maher C, Jelovsek JE. Complication and reoperation rates after apical vaginal prolapse surgical repair: a systematic review. Obstet Gynecol 2009;113:367–73.
    1. Jacquetin B, Cosson M. Complications of vaginal mesh: our experience. Int Urogynecol J Pelvic Floor Dysfunct 2009;20:893–6.

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