OBJECTIVE: Our purpose was to determine the objective and subjective efficacy of transvaginal electrical stimulation for treatment of common forms of urinary incontinence in women. STUDY DESIGN: A prospective, double-blind, randomized clinical trial included 121 women with either urinary incontinence caused by detrusor instability or genuine stress incontinence, or both (mixed incontinence). Participants used the assigned device for 8 weeks. Identical preintervention and postintervention assessment included multichannel urodynamic testing, quality-of-life scale, and urinary diaries. RESULTS: A total of 121 women completed this study at four North American urogynecology centers. Detrusor instability was cured (stable on provocative cystometry) in 49% of women with detrusor instability who used an active electrical device (p = 0.0004, McNemar's test), whereas there was no statistically significant change in the percentage with detrusor instability in the sham device group. There was no statistically significant difference between the preintervention and postintervention rates of genuine stress incontinence for either the active device group or the sham device group. CONCLUSION: This form of transvaginal electrical stimulation may be effective for treatment of detrusor overactivity, with or without genuine stress incontinence.
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