Conditions: Urinary Incontinence
Keywords: Radical Robotic Arm Vesicare Post Prostatectomy Incontinence YM905
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 640
Healthy volunteers: no

Brief summary:
The purpose of this study is to assess the efficacy and safety of 12 weeks of treatment of solifenacin succinate versus placebo in participants who are incontinent after Robotic Assisted Radical Prostatectomy.

This study will also assess the effect of 12 weeks of treatment with solifenacin succinate versus placebo on quality of life (QOL) as measured by questionnaires.

Detailed description:
The study duration includes a 14-day treatment free wash-out period. The maximum total study duration is 15 weeks (2-3 week screening/washout period and a 12 week treatment period). The Baseline, Week 4, and Week 8 visits will be telephone contact visits.

Participants will complete an electronic daily pad use diary during the study

duration. Participants will also be asked to complete several questionnaires during the study.

Arms:
arm 1: Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily. arm 2: Participants received matching placebo tablets once a day for 12 weeks.

Interventions: intervention 1: solifenacin succinate intervention 2: Placebo
Intervention descriptions: intervention 1: oral intervention 2: oral

Protocol document: