Vaginal Repair With Mesh Versus Colporrhaphy for Prolapse: A Randomized Controlled Trial

Abstract

The use of synthetic mesh to augment vaginal repair procedures for pelvic organ prolapse has increased in large part because of dissatisfaction with the success rates of traditional colporrhaphy. Its use, however, is controversial. Four randomized controlled studies comparing traditional colporrhaphy with vaginal repair using mesh augmentation had conflicting results. This unblinded, prospective, randomized controlled trial investigated whether mesh augmentation during vaginal repair would reduce the rate of recurrent prolapse at 12 months compared with traditional colporrhaphy. A total of 139 women with stage 2 or more prolapse who required both anterior and posterior compartment repair were randomized to mesh augmentation (mesh group, n ϭ 69) or colporrhaphy (no mesh group, n ϭ 70). Study subjects were enrolled between 2003 and 2005 at a tertiary teaching hospital. Prolapse was staged using the pelvic-organ-prolapse quantification (POP-Q) system. The primary study outcome was objective success of surgery defined as the absence of POP-Q stage 2 or more prolapse at 12 months following surgery. Questionnaires were used to assess secondary outcomes including symptoms, quality of life, and patient satisfaction.Of the 139 women, 63 of 69 (93.1%) in the mesh group and 61 of 70 (87.1%) in the no mesh group attended the 12-month follow-up. There was no significant difference at 12 months in objective success (POP-Q stage 0 or 1) between the mesh and no mesh groups (mesh: 81.0% ͓51/63͔ vs. no mesh: 65.6% ͓40/61͔; P ϭ 0.07). Although patients in both groups expressed a high level of satisfaction with the surgery and improved symptoms and parameters of quality of life compared to baseline, there was no statistically significant difference in these outcomes between the 2 groups (P ϭ ns). Postoperative complications in the mesh group included four cases (5.6%) of vaginal mesh exposure. At 12 months, de novo dyspareunia was reported in 27.8% (5/18) of the sexually active women without preoperative dyspareunia in the mesh group and in 41.7% (5/12) of those in the no mesh group. These differences were not significant (P ϭ 0.46).These findings show that anterior and posterior vaginal repair with mesh augmentation at 12 months after surgery does not result in significantly less recurrent prolapse than traditional colporrhaphy.

Use of vaginal mesh for pelvic organ prolapse repair: a literature review

“…In randomized studies, there was no significant difference between the two techniques (traditional surgery or using graft) when comparing "average blood loss" (596 patients in seven studies) [5,7,13,14,[18][19][20] or "important blood loss" (446 patients in four studies) [6,9,12,17]. A superior blood loss in the group with prosthetic reinforcement was found by Hiltunen and Altman [6,23].…”

“…One of these studies demonstrates after a 3-year follow-up the anatomic benefit of NAS meshes (12% of recurrence after 104 grafts versus 41% after 96 traditional surgery) [22]. Carey did not find any benefit with a sub-vesical mesh, but in his surgical description, it was the only observation where prosthesis was left free without any suspension [12]. This technical variation seems to be important: in all other studies, subvesical mesh is suspended by its four arms.…”

“…The global rate of relapse at 1 year is estimated around 37% after traditional surgery (87 patients out of 237) and at 11% with NAS mesh (27 patients out of 247) [6,[10][11][12]. We must remain careful: our review does not represent a meta-analysis, and many biases may exist.…”

“…Sixteen randomized trials matching our inclusion criteria were published: one in 2006 [5], two in 2007 [6,7], four in 2008 [8][9][10][11], four in 2009 [12][13][14][15] and five in 2010 [16][17][18][19][20]. We added two publications of Nieminen, reporting long-term results of the randomized trial initially written by Hiltunen in 2007 [6,21,22].…”

Optimal repair of pelvic organ prolapse: the debate continues

“…Guerette et al [30] determined that the anatomic success rate at two years of follow-up was similar in women undergoing bovine pericardium interposition and those undergoing anterior colporrhaphy alone. At 12 months of follow-up, Carey et al [31] observed an anatomic success rate of 81% in women undergoing polypropylene mesh augmentation vs. 65.6% in the no-mesh group, with a high level of postoperative satisfaction and QoL improvement observed in both groups. Finally, a meta-analysis encompassing 49 studies and more than 4,500 women determined that nonabsorbable synthetic mesh had a significantly lower objective anterior compartment recurrence rate (8.8%) than either absorbable synthetic mesh (23.1%) or biological graft (17.9%).…”