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

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Collaborator: Astellas Pharma Europe B.V.
• Treatments: Solifenacin Succinate

Criteria

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