A Multicenter VESIcare® Efficacy and Safety Study for the Treatment of Urgency Associated With Overactive Bladder (OAB) (VENUS)

Astellas

Status and phase: Completed; Phase 3

Conditions: Urinary Bladder, Overactive

Treatments: Drug: VESIcare®; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00454896

905-UC-005

Details and patient eligibility

About

The purpose is to evaluate the efficacy of 5 and 10mg VESIcare® (solifenacin succinate) in patients with urgency who have overactive bladder syndrome.

Enrollment: 739 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least 1 urinary urgency episode/24h (on average) documented in a 3-day patient diary in the screening phase with or without urge incontinence, and usually with frequency and nocturia, described as OAB
• Patients may be included if they were never exposed to anticholinergic agents specified for the treatment of OAB. Patients may also be included if they have previously been treated with FDA-approved anticholinergic agents for the treatment of OAB such as oxybutynin chloride and are no longer receiving such treatment for a minimum of 14 days immediately preceding entry into the study. These previously treated patients must present at the investigative site on no anticholinergic agents and with the desire to receive treatment for OAB. 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.
• Patients having urgency with or without urge incontinence accompanied by frequency of ≥8 episodes per 24 hours, and/or nocturia, for a period of ≥3 months prior to screening.

Exclusion criteria

• Previous treatment with darifenacin
• Duration of urgency with or without urge incontinence, usually accompanied with frequency and nocturia for <3 months
• Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the Investigator
• Evidence of a urinary tract infection; chronic inflammation such as interstitial cystitis and bladder stones
• Clinically significant outflow obstruction (benign prostatic hyperplasia) as determined by the Investigator

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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739 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: VESIcare®

2

Placebo Comparator group

Treatment:

Drug: placebo