EFFICACY OF FUNCTIONAL ELECTRICAL-STIMULATION IN TREATING GENUINE STRESS-INCONTINENCE - A RANDOMIZED CLINICAL-TRIAL

Our objective was to determine the efficacy of functional electrical s timulation as a stand-alone therapy for female stress incontinence. Th e study was conducted as a prospective, double-blind, randomized contr olled trial using subjective and objective outcome criteria. Patients enrolled in this study had stress incontinence consistent with Interna tional Continence Society criteria. Patients with significant pelvic p rolapse or detrusor instability were excluded. Patients underwent twic e-daily treatment sessions for a total of 3 months. Results were analy zed for confounding variables between the treatment and control groups . Statistical analysis was performed utilizing Fisher's exact test and the paired t-test. Of the 54 patients enrolled in this study, 44 comp leted the program. The dropout rate was similar for both the treatment and control groups. There was no statistically significant difference between the treatment and control groups with regard to age, gravity, parity. previous anti-incontinence surgery, menopausal status, or pre vious hysterectomy. Objective success for the treatment group was 15% and fur the control group, 12.5% (NS). The subjective success for the treatment group was 25% and for the control group, 29% (NS). There was no relationship demonstrated between age, parity, previous surgery, h ysterectomy, or menopausal status and the successful treatment of genu ine stress incontinence with functional electrical stimulation. In thi s patient population, functional electrical stimulation was no more ef fective at improving or eliminating the symptoms of genuine stress inc ontinence than was the daily retention of the control probe. (C) 1997 Wiley-Liss, Inc.