Efficacy and Safety of Propiverine Chloride Flexible Dose in Female Mixed Urinary Incontinence Patients

Abstract

Purpose: We investigated the efficacy and safety of propiverine chloride (BUP-4) flexible dose in female patient with mixed urinary incontinence. Methods:The participants were women with mixed incontinence, including urgency (grade 3 or more, one or more episodes per day) or mild stress incontinence (grade I) or both. The subjects were received 4 weeks of treatment with propiverine 20 mg once daily. If the response of the 4 week treatment was insufficient, the dose was increased to 30 mg/day. The patient who satisfied with initial treatment sustained propiverine 20 mg for next 8 weeks. The efficacy of treatment was assessed base on the response of Benefit, Satisfaction and Willingness to Continue questionnaire (BSW questionnaire). Change of Overactive Bladder Symptom Score (OABSS), micturition diary parameters was assessed. Adverse events were evaluated throughout the study. Results:A total of 86 patients with mixed incontinence were enrolled, 76 patients completed the 3 month study. 29 patients (33.7%) responded as "dissatisfied" with the treatment at week 4 and treated with escalated dose to 30 mg propiverine next 8 weeks. (20 mg group; 48 subjects, 30 mg group; 28 subjects) 90% of patients in 30 mg group satisfied with their treatment at final follow-up on week 12. Three patients still dissatisfied with 30 mg propiverine treatment in spite of escalating the dose. The change in OABSS score were significantly improved after 12 week propiverine treatment at both groups. Most clinical parameters showed much more improvement in 20 mg group than 30 mg group. Most common adverse event was dry mouth and constipation. Two patients complained dry mouth, one patient had constipation and two patients had dyspepsia. Conclusions:Propiverine 30 mg could be an effective treatment of mixed incontinence without increasing the incidence of side effect compared to propiverine 20 mg. It could be considered to propiverine 30 mg as a starting dose.