INTRODUCTION AND HYPOTHESIS: To compare the efficacy of a collagen-coated polypropylene mesh and anterior colporrhaphy in the treatment of stage 2 or more anterior vaginal wall prolapse. METHODS: Prospective, randomized, multicenter study conducted between April 2005 and December 2009. The principal endpoint was the recurrence rate of stage 2 or more anterior vaginal wall prolapse 12 months after surgery. Secondary endpoints consisted of functional results and mesh-related morbidity. RESULTS:One hundred and forty-seven patients were included, randomized and analyzed: 72 in the anterior colporrhaphy group and 75 in the mesh group. The anatomical success rate was significantly higher in the mesh group (89%) than in the colporrhaphy group (64%) (p = 0.0006). Anatomical and functional recurrence was also less frequent in the mesh group (31.3% vs 52.2%, p = 0.007). Two patients (2.8%) were reoperated on in the colporrhaphy group for anterior vaginal wall prolapse recurrence. No significant difference was noted regarding minor complications. An erosion rate of 9.5% was noted. De novo dyspareunia occurred in 1/14 patients in the colporrhaphy group and in 3/13 patients in the mesh group. An analysis of the quality of life questionnaires showed an overall improvement in both groups, with no statistical difference between them. Satisfaction rates were high in both groups (92% in the colporrhaphy group and 96% in the mesh group). CONCLUSION:Trans-obturator Ugytex mesh used to treat anterior vaginal wall prolapse gives better 1-year anatomical results than traditional anterior colporrhaphy, but with small a increase in morbidity in the mesh group.
RCT Entities:
INTRODUCTION AND HYPOTHESIS: To compare the efficacy of a collagen-coated polypropylene mesh and anterior colporrhaphy in the treatment of stage 2 or more anterior vaginal wall prolapse. METHODS: Prospective, randomized, multicenter study conducted between April 2005 and December 2009. The principal endpoint was the recurrence rate of stage 2 or more anterior vaginal wall prolapse 12 months after surgery. Secondary endpoints consisted of functional results and mesh-related morbidity. RESULTS: One hundred and forty-seven patients were included, randomized and analyzed: 72 in the anterior colporrhaphy group and 75 in the mesh group. The anatomical success rate was significantly higher in the mesh group (89%) than in the colporrhaphy group (64%) (p = 0.0006). Anatomical and functional recurrence was also less frequent in the mesh group (31.3% vs 52.2%, p = 0.007). Two patients (2.8%) were reoperated on in the colporrhaphy group for anterior vaginal wall prolapse recurrence. No significant difference was noted regarding minor complications. An erosion rate of 9.5% was noted. De novo dyspareunia occurred in 1/14 patients in the colporrhaphy group and in 3/13 patients in the mesh group. An analysis of the quality of life questionnaires showed an overall improvement in both groups, with no statistical difference between them. Satisfaction rates were high in both groups (92% in the colporrhaphy group and 96% in the mesh group). CONCLUSION: Trans-obturator Ugytex mesh used to treat anterior vaginal wall prolapse gives better 1-year anatomical results than traditional anterior colporrhaphy, but with small a increase in morbidity in the mesh group.
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