Study of VESIcare® In Overactive Bladder (OAB) Subjects to Evaluate Symptom Bother and Health Related Quality of Life

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Evaluate the effect of VESIcare® on symptom bother for subjects with OAB

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

Details

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

Criteria

Inclusion Criteria:

• Ambulatory male or female subject ≥ 18 years of age and able to use the toilet without difficulty

• History of OAB symptoms for ≥ 3 months

• An average of ≥ 8 micturitions per 24 hours and ≥ 1 urgency episode (with or without incontinence) per 24 hours as documented in a 3-day micturition diary

• Subjects are bothered by symptoms as reflected by PPBC ≥3

Exclusion Criteria:

• Evidence of chronic urologic inflammation such as interstitial cystitis and bladder stones; uncontrolled narrow angle glaucoma; urinary or gastric retention

• Recurrent urinary tract infection (UTI) of > 3 episodes within the last 3 months or evidence of a urinary tract infection at Baseline Visit (Visit 2)

• Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the investigator

• History of renal or hepatic impairment(2 x Upper Limit of Normal(ULN) values in parameters and considered clinically significant by the investigator

• History of diagnosed gastrointestinal obstruction disease

• Subject has a known diagnosis or history of carcinoma (including prostate cancer) except non metastatic basal or squamous cell carcinoma of the skin that has been successfully treated or previous pelvis radiation within the past five years

• Known or suspected hypersensitivity to solifenacin succinate, any components, or other anticholinergics