Dose Ranging Study Of Solabegron Versus Placebo In Female Patients With Overactive Bladder Symptoms

Recruitment & Eligibility

Inclusion Criteria

Overactive bladder with symptoms of urgency with urge incontinence and frequency which may be associated with nocturia but without bladder pain.
Body mass index in the range of = 19 kg/m2 to <35 kg/m2.

Exclusion Criteria

Pregnant
Of childbearing potential or willing to use specific barrier methods outlined in the protocol.
Grade III/IV pelvic organ prolapse with or without cystocele.
History of interstitial cystitis or bladder related pain.
Stress incontinence or mixed incontinence where stress incontinence is the predominant component based on prior history.
History of pelvic prolapse repair (cystocele or rectocele) or urethral diverticulectomy within six months of screening.
Urinary incontinence due to causes other then detrusor over activity (e.g., overflow incontinence).
Nocturnal enuresis only.
Urinary retention, or other evidence of poor detrusor function.
Current or history of Urinary Tract Infection.
Diabetes insipidus.
History of myocardial infarction, unstable angina, or Congestive heart failure.
Chronic severe constipation.
History of prior anti-incontinence surgery.
History of radiation cystitis or a history of pelvic irradiation.
Electrostimulation, biofeedback, or bladder training therapy (behavioral therapy) during the previous month prior to screening, or the intention to initiate such therapies during the study. Pessaries and implants are also excluded.
Received any investigational product within 30 days of enrollment into the study.

Study & Design

Primary Outcome Measures

Name	Time	Method
Percent reduction in the number of incontinence episodes per 24 hrs after 8 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Improvement overactive bladder symptoms per 24 hrs after 4 and 8 weeks of treatment. Improvement in health related Qol. Descriptive statistics of solabegron and it's primary metabolite.

Recruitment & Eligibility