Open-label Study of the Efficacy and Safety of VESIcare® in Patients With Overactive Bladder Symptoms

• Status: Completed
• Trial end date: 2005-04-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the safety and efficacy of solifenacin succinate in subjects with overactive bladder symptoms (urgency, with or without urge incontinence, usually with frequency and nocturia).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Solifenacin Succinate

Criteria

Inclusion Criteria:

• Symptoms of OAB (urgency, with or without urge incontinence, usually with frequency and nocturia) for ≥3 or more months.

• Patients may be included if they are on another OAB medication; however, patients must washout from other OAB medications for at least 7 days prior to receiving solifenacin succinate. Previous non-drug treatment of OAB is allowed if it has been established at least 4 weeks prior to study entry and is continued throughout the study.

Exclusion Criteria:

• -Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor

• Evidence of urinary tract infection; chronic inflammation such as interstitial cystitis and bladder stones

• Clinically significant outflow obstruction (benign prostatic hyperplasia)