NCT00337558

A Study of Solifenacin With Bladder Training Versus Solifenacin Alone in Patients With Overactive Bladder (SOLAR)

Solifenacin Succinate in a Flexible Dose Regimen With Simplified Bladder Training Versus Solifenacin Succinate in a Flexible Dose Regimen Alone in a Prospective, Randomized, Parallel Group, Overactive Bladder Symptom Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 643 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will look at a drug for OAB (solifenacin) in combination with a non drug treatment (bladder training) compared to the drug on its own. The study will compare the symptoms of OAB by assessing patient diaries and other patient reported outcomes.

Detailed description

Subjects are screened between day -14 and day -1. At day 0 subjects will enter a randomized, parallel group study. After fulfilling all selection criteria, subjects will be randomized to one of two treatment arms, solifenacin 5mg with bladder training or solifenacin 5mg alone. After 8 weeks of treatment subjects will be sub divided; subjects on solifenacin 5mg with bladder training will be given the option to increase dose and be divided into solifenacin 5mg with bladder training or solifenacin 10mg with bladder training. Subjects on solifenacin alone, will also be given the option to increase dose and be divided into solifenacin 5mg alone and solifenacin 10mg alone. There are 5 visits in total: visit 1(screening), visit 2 (randomisation), visit 3 (week 4), visit 4 (week 8), telephone visit (week 12) and visit 5 (week 16) All subjects receive medication in the form of solifenacin succinate 5mg tablets (two tablets for 10mg) (Company code: YM905, Company serial number: RVG29151) Subjects randomized to bladder training will receive a single sheet of instructions for bladder training.

Conditions

• Overactive Bladder
• Urinary Incontinence
• Urge Incontinence

Interventions

Type	Name	Description
DRUG	Solifenacin succinate	tablet
BEHAVIORAL	Simplified bladder training	Instructions

Timeline

• Start date: 2006-05-01
• Primary completion: 2007-05-01
• Completion: 2007-05-01
• First posted: 2006-06-16
• Last updated: 2014-09-18

Locations

64 sites across 11 countries: Australia, Belgium, Czechia, France, Hungary, Italy, Netherlands, Poland, Russia, Spain, Turkey (Türkiye)