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OBJECTIVE: To determine the utility of the urethral plug in the management of female stress urinary incontinence. METHODS: A prospective clinical study was conducted in 20 female patients with stress urinary incontinence in order to evaluate the efficacy of a new urethral plug. The mean age was 59.6 +/- 6.2 years (range 40-66). The study design included 3 visits (4 weeks). The results were considered "positive" when urinary incontinence decreased and the patient referred a subjective sensation of improvement, and "negative" if otherwise. RESULTS: Positive results were demonstrated in 8 patients (40%). Ten patients (50%) refused to continue, mainly due to urinary tract infection in 7 cases (35%), difficulties in plug use (loss of plugs, anomalous urethral anatomy, cystocele,...) in 6 cases (30%) and urethral mucosa irritation in one case (5%). No plug migrated into the bladder. The initial urinary incontinence grade in the positive cases were: minor in 4 (50%), mild in 2 (25%) and severe in 2 (25%). We found no statistical relationship between the urinary incontinence grade and clinical results. The patients used a median of 5 plugs per day. Of the 10 patients who completed the study, 5 (50%) refused to continue using the plug and 5 (50%) decided to continue using the plug in combination with electrostimulation and/or pelvic floor exercises. CONCLUSIONS: The use of the urethral plug in the management of female stress urinary incontinence is not an alternative to surgical treatment or pelvic floor rehabilitation. However, it could be useful for patients who are unwilling or unfit for surgery. Finally, the urethral plug is an alternative to the use of collecting systems or devices in female stress urinary incontinence.