Therapeutic effect of propiverine hydrochloride on mixed‐type urinary incontinence in women: The Female Urgency and Stress Urinary Incontinence Study of Propiverine Hydrochloride trial

Objectives To show the efficacy of propiverine hydrochloride in the management of symptoms of stress urinary incontinence in female patients with mixed‐type urinary incontinence. Methods The study was carried out as a multicenter single‐arm clinical trial at 64 institutions in Japan. The participants were female patients aged ≥20 years with mixed‐type urinary incontinence. The frequency of stress urinary incontinence and urgency urinary incontinence was evaluated at baseline and 4, 8 and 12 weeks after treatment with propiverine hydrochloride. Subjective symptoms were evaluated using the Overactive Bladder Symptom Score and the International Consultation on Incontinence Questionnaire‐Short Form. Functional urethral length and maximum urethral closing pressure were also measured at baseline and 12 weeks after treatment at the institutions where the urethral pressure profile was taken. Results In total, 49 mixed‐type urinary incontinence patients were enrolled in the present study. The number of cases of urgency urinary incontinence was reduced time‐dependently, which showed statistically significant differences between baseline and 4, 8 and 12 weeks after treatment. A similar statistically different reduction was also observed for stress urinary incontinence. The mean reduction rates of urgency urinary incontinence and stress urinary incontinence at 12 weeks after treatment were 63.9% and 44.3%, respectively. The total scores of International Consultation on Incontinence Questionnaire‐Short Form and Overactive Bladder Symptom Score were gradually reduced, and the differences were statistically significant. Functional urethral length and maximum urethral closing pressure at 12 weeks after treatment did not show any statistical differences compared with those at baseline. Conclusions Propiverine hydrochloride can be an effective therapeutic option for stress urinary incontinence in patients with mixed‐type urinary incontinence.