OBJECTIVE: This study was undertaken to compare outcomes after anterior colporrhaphy with and without a solvent dehydrated cadaveric fascia lata graft. STUDY DESIGN:A total of 162 women were enrolled in a prospective, randomized trial that evaluated the impact of a solvent dehydrated cadaveric fascia lata patch on recurrent anterior vaginal prolapse. Subjects were randomly assigned to standard colporrhaphy with or without a patch. Before and after surgery, subjects were evaluated by both the Baden-Walker and pelvic organ prolapse quantification systems. "Failure" was defined as stage II anterior wall prolapse or worse. RESULTS: Of 154 women randomly assigned (76 patch: 78 no patch), all underwent surgery and 153 (99%) returned for follow-up. Sixteen women (21%) in the patch group and 23 (29%) in the control group experienced recurrent anterior vaginal wall prolapse (P = .229). Only 26% of all recurrences were symptomatic. Concomitant transvaginal Cooper's ligament sling procedures were associated with a dramatic decrease in recurrent prolapse (odds ratio [OR] 0.105 , P < .0001). CONCLUSION:Solvent dehydrated fascia lata as a barrier does not decrease recurrent prolapse after anterior colporrhaphy. Transvaginal bladder neck slings were associated with a significant reduction in the risk of recurrent anterior wall prolapse.
RCT Entities:
OBJECTIVE: This study was undertaken to compare outcomes after anterior colporrhaphy with and without a solvent dehydrated cadaveric fascia lata graft. STUDY DESIGN: A total of 162 women were enrolled in a prospective, randomized trial that evaluated the impact of a solvent dehydrated cadaveric fascia lata patch on recurrent anterior vaginal prolapse. Subjects were randomly assigned to standard colporrhaphy with or without a patch. Before and after surgery, subjects were evaluated by both the Baden-Walker and pelvic organ prolapse quantification systems. "Failure" was defined as stage II anterior wall prolapse or worse. RESULTS: Of 154 women randomly assigned (76 patch: 78 no patch), all underwent surgery and 153 (99%) returned for follow-up. Sixteen women (21%) in the patch group and 23 (29%) in the control group experienced recurrent anterior vaginal wall prolapse (P = .229). Only 26% of all recurrences were symptomatic. Concomitant transvaginal Cooper's ligament sling procedures were associated with a dramatic decrease in recurrent prolapse (odds ratio [OR] 0.105 , P < .0001). CONCLUSION: Solvent dehydrated fascia lata as a barrier does not decrease recurrent prolapse after anterior colporrhaphy. Transvaginal bladder neck slings were associated with a significant reduction in the risk of recurrent anterior wall prolapse.
Authors: Sylvia M Botros; Peter K Sand; Jennifer L Beaumont; Yoram Abramov; Jay James Miller; Roger P Goldberg Journal: Int Urogynecol J Pelvic Floor Dysfunct Date: 2009-06-17