PURPOSE: We evaluated the safety and efficacy of using human dermal allograft material for transvaginal slings to treat female stress urinary incontinence (SUI). MATERIALS AND METHODS: We present a prospective series of 253 patients with SUI treated with a transvaginal sling using a Repliform cadaveric human dermal allograft (LifeCell Corp., The Woodlands, Texas) and a bone anchor fixation kit. Clinical history, urogynecologic examination and videourodynamics were performed preoperatively. Results were assessed by a third party through validated quality of life questionnaires (Incontinence Impact Questionnaire and Urogenital Distress Inventory), overall impression and percent of improvement as perceived by the patients, and pad use. Scheduled followup examination were performed to rule out erosion, infection, obstruction, pain or recurrent incontinence. RESULTS: Complete followup was available on 234 of 253 patients. Average followup was 18 months. Of the patients 78% were cured or improved according to the questionnaires. The average improvement was 80%. At 18 months of followup incontinence average distress and scores decreased 10 and 7 points, respectively. Complications were de novo urgency in 5% of cases, recurrent SUI in 15% with no cases of persistent SUI, retention in 2% and slow vaginal wall healing in 1.7%. Of 156 patients 51 (22%) had persistent urgency. There were no cases of vaginal or urethral erosion, osteitis pubis or osteomyelitis. CONCLUSIONS: Our data indicate that use of human dermal allograft for transvaginal slings is associated with low complication rates and favorable outcomes at an average of 18 months of followup.
PURPOSE: We evaluated the safety and efficacy of using human dermal allograft material for transvaginal slings to treat female stress urinary incontinence (SUI). MATERIALS AND METHODS: We present a prospective series of 253 patients with SUI treated with a transvaginal sling using a Repliform cadaveric human dermal allograft (LifeCell Corp., The Woodlands, Texas) and a bone anchor fixation kit. Clinical history, urogynecologic examination and videourodynamics were performed preoperatively. Results were assessed by a third party through validated quality of life questionnaires (Incontinence Impact Questionnaire and Urogenital Distress Inventory), overall impression and percent of improvement as perceived by the patients, and pad use. Scheduled followup examination were performed to rule out erosion, infection, obstruction, pain or recurrent incontinence. RESULTS: Complete followup was available on 234 of 253 patients. Average followup was 18 months. Of the patients 78% were cured or improved according to the questionnaires. The average improvement was 80%. At 18 months of followup incontinence average distress and scores decreased 10 and 7 points, respectively. Complications were de novo urgency in 5% of cases, recurrent SUI in 15% with no cases of persistent SUI, retention in 2% and slow vaginal wall healing in 1.7%. Of 156 patients 51 (22%) had persistent urgency. There were no cases of vaginal or urethral erosion, osteitis pubis or osteomyelitis. CONCLUSIONS: Our data indicate that use of human dermal allograft for transvaginal slings is associated with low complication rates and favorable outcomes at an average of 18 months of followup.
Authors: John T Stoffel; Gjange Smith; Simone Crivellaro; John J Smith; John F Bresette Journal: Int Urogynecol J Pelvic Floor Dysfunct Date: 2009-07-01