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

Phase 4

Completed

• Conditions: Overactive Bladder; Urinary Incontinence; Urge Incontinence
• Interventions: Behavioral: Simplified bladder training; Drug: Solifenacin succinate

• Registration Number: NCT00337558
• Lead Sponsor: Astellas Pharma Inc

Brief 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.

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-06-14
• Study First Submitted QC: 2006-06-15
• Study First Posted: 2006-06-16
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-17
• Last Update Posted: 2014-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 643

Inclusion Criteria

• Symptoms of overactive bladder (including urinary frequency, urgency with/without urge incontinence) for> 3 months

Exclusion Criteria

• Clinically significant outflow obstruction
• Significant post void residual volume
• Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the investigator.
• Patient with a neurological cause for abnormal detrusor activity.
• Evidence of a symptomatic urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Simplified bladder training	Solifenacin succinate and simplified bladder training
1	Solifenacin succinate	Solifenacin succinate

Primary Outcome Measures

Name	Time	Method
Change from baseline in mean number of micturitions per 24 hours after 8 weeks	8 weeks

Secondary Outcome Measures

Name	Time	Method
Incidence and severity of adverse events	8 and 16 weeks
Change from baseline in mean number of micturitions per 24 hours after 16 weeks	16 weeks
Change from baseline in mean urgency frequency per 24 hours	8 and 16 weeks
Change from baseline in mean number of incontinence and urge incontinence episodes per 24 hours	8 and 16 weeks
Change from baseline in number of pads used	8 and 16 weeks