OBJECTIVE: To compare outcomes of anterior colporrhaphy alone to that reinforced with bovine pericardium graft. METHODS:Women with anterior vaginal wall prolapse were enrolled in a randomized fashion in this grafted compared with nongrafted repair study. Outcome measures included pelvic organ prolapse quantification data, quality-of-life assessment, healing abnormalities, and complications. RESULTS:Ninety-four patients were enrolled. Seventy-two (77%) provided 1-year data, and 59 (63%) supplied 2-year data. Demographics and stage of prolapse were similar between groups at baseline. Postoperative complications consisted basically of low urinary tract infection and were low in both groups (10 in bovine pericardium graft and 16 in anterior colporrhaphy alone). One year after surgery, successful anterior vaginal wall support was obtained in 85.7% of the bovine pericardium graft group and 78.4% of anterior colporrhaphy-alone group (P=.544). For the cohort that comprised 2-year analyses, the success rate was 76.5% for the bovine pericardium graft group and 63% for anterior colporrhaphy-alone group (P=.509). Postoperative Urogenital Distress Inventory-6 andPelvic Organ Prolapse-Urinary IncontinenceSexual Function Questionnaire-12 scores were uniformly improved over baseline in both groups. CONCLUSION: The use of bovine pericardium graft for anterior vaginal prolapse does not have higher complication rates or healing difficulties. At 1- and 2-year follow-up, anterior colporrhaphy with bovine pericardium reinforcement did not show a statistically significant improvement over colporrhaphy alone. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00860912 LEVEL OF EVIDENCE: I.
RCT Entities:
OBJECTIVE: To compare outcomes of anterior colporrhaphy alone to that reinforced with bovine pericardium graft. METHODS:Women with anterior vaginal wall prolapse were enrolled in a randomized fashion in this grafted compared with nongrafted repair study. Outcome measures included pelvic organ prolapse quantification data, quality-of-life assessment, healing abnormalities, and complications. RESULTS: Ninety-four patients were enrolled. Seventy-two (77%) provided 1-year data, and 59 (63%) supplied 2-year data. Demographics and stage of prolapse were similar between groups at baseline. Postoperative complications consisted basically of low urinary tract infection and were low in both groups (10 in bovine pericardium graft and 16 in anterior colporrhaphy alone). One year after surgery, successful anterior vaginal wall support was obtained in 85.7% of the bovine pericardium graft group and 78.4% of anterior colporrhaphy-alone group (P=.544). For the cohort that comprised 2-year analyses, the success rate was 76.5% for the bovine pericardium graft group and 63% for anterior colporrhaphy-alone group (P=.509). Postoperative Urogenital Distress Inventory-6 and Pelvic Organ Prolapse-Urinary Incontinence Sexual Function Questionnaire-12 scores were uniformly improved over baseline in both groups. CONCLUSION: The use of bovine pericardium graft for anterior vaginal prolapse does not have higher complication rates or healing difficulties. At 1- and 2-year follow-up, anterior colporrhaphy with bovine pericardium reinforcement did not show a statistically significant improvement over colporrhaphy alone. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00860912 LEVEL OF EVIDENCE: I.