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Therapeutic Areas: Nephrology/Urology
Disease Category: Bladder Disorders

Trial Information

A Multicenter Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of a Single Treatment in Patients with Idiopathic Overactive Bladder

Patients with symptoms of iOAB with urinary urge incontinence for at lease 6 months, whose symptoms have not been adequately managed with anticholinergic therapy.

Key Inclusion Criteria: Patient is male or female, ≤ 18 years of age; experiences 3 or more episodes of micturitions per day; patient is willing to use clean intermittent catherization to empty the bladder at any time after study treatment if deemed necessary by the investigator.

Key Exclusion Criteria: Patient has a predominance of stress incontinence, has received anticholinergix or sympathomimetic medication for OAB within 28 days prior to Randomization/Day 1, has received botulinum toxin therapy of any serotype for any urological condition, has a screening PVR > 100mL, has been treated for urinary retention or elevated PVR not related to surgeries within 6 months prior to screening, has a history of ≤ 2 UTIs within 6 months prior to screening, has a 24-hour total volume of urine voided > 3000mL during the 3-day bladder diary collection period prior to Randomization/Day 1.

Following a potential one week washout period and screening period of 21 days, eligible patients will be randomized or placebo into the detrusor. A second treatment may be administered within 12-24 weeks post randomization (Treatment 1) for patients who meet the re-treatment criteria. The patient participations period will be a minimum of 24 weeks and a maximum of 38 weeks.

the change in urinary incontinence episodes from baseline to Week 12.

AdvanceMed Research
2 Princess Rd., Suite J
Lawrenceville, NJ 8648
Phone: (609) 895-0735

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