Efficacy of functional electrical stimulation in treating genuine stress incontinence: a randomized clinical trial.

Our objective was to determine the efficacy of functional electrical stimulation as a stand-alone therapy for female stress incontinence. The study was conducted as a prospective, double-blind, randomized controlled trial using subjective and objective outcome criteria. Patients enrolled in this study had stress incontinence consistent with International Continence Society criteria. Patients with significant pelvic prolapse or detrusor instability were excluded. Patients underwent twice-daily treatment sessions for a total of 3 months. Results were analyzed 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 completed 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 antiincontinence surgery, menopausal status, or previous hysterectomy. Objective success for the treatment group was 15% and for 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, hysterectomy, or menopausal status and the successful treatment of genuine stress incontinence with functional electrical stimulation. In this patient population, functional electrical stimulation was no more effective at improving or eliminating the symptoms of genuine stress incontinence than was the daily retention of the control probe.