Low-weight polypropylene mesh for anterior vaginal wall prolapse: a randomized controlled trial.

OBJECTIVE: To compare anterior colporrhaphy with and without a tailored mesh.
METHODS: Postmenopausal women with anterior vaginal prolapse to the hymen or beyond were randomly assigned to undergo traditional anterior colporrhaphy alone or reinforced with mesh. The low-weight monofilament polypropylene mesh was self-tailored, having four arms and being placed over the plicated fascia. Before and 2 and 12 months after surgery, participants were evaluated by physical examination, postvoidal residual urine measurement and standard questions covering prolapse-related symptoms. The primary outcome was recurrence of anterior vaginal prolapse at 12 months. Secondary outcomes included operative complications, symptom resolution, and postvoidal urine residual volume.
RESULTS: Of the 202 women randomly assigned, 201 were operated on (97 without, 104 with mesh). Thirty-seven women (38.5%) in the no-mesh and seven (6.7%) in the mesh group experienced a recurrence of anterior wall prolapse (P<.001) at 12 months; as a result, the number needed to treat for benefit was four. The mean (standard deviation) postvoidal residual urine volume was lower in patients with mesh than in those undergoing the traditional operation: 25 (26) mL and 41 (57) mL (P=.01). Twenty-three women (23%) with mesh and 9 (10%) with no mesh reported stress urinary incontinence (P=.02). In 18 (17.3%), exposure of the mesh was noted, mainly asymptomatic.
CONCLUSION: Anterior colporrhaphy, reinforced with, tailored mesh significantly reduced the rate of recurrence of anterior vaginal wall prolapse compared with the traditional operation, but was associated more often with stress urinary incontinence.

RCT Entities:   Population Interventions Outcomes