Overview

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)