A Multicentre, Placebo Controlled, Randomised, Double-blind, Dose Ranging Study of SVT-40776 0.05 mg, 0.1 mg, 0.2 mg, Tolterodine 4 mg and Placebo Daily Doses for 4 Weeks in Patients Suffering from Overactive Bladder Syndrome
- Conditions
- urine urgencyurinate too frequent10004994
- Registration Number
- NL-OMON29948
- Lead Sponsor
- Salvat Laboratorios
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 13
Patients suffering from OAB based on three cardinal symptoms (urgency with or without urge incontinence, usually accompanied by frequency or nocturia) for at least 6 months prior to inclusion
Patients must document during the 14-day placebo run-in period an average of ><= 10 micturitions/ 24 hours and either a total of ><= 3 incontinence episodes or a total of ><= 3 urgency episodes in the patient diary
Patients with clinically significant bladder neck obstructions defined as post-void residual urine volumes grater than 100mL.
Patients with free uroflow <15 mL/ sec in males or <10 mL/sec in females.
Patients with clinically predominant stress incontinence (>=2 episodes per week)
Patients suffering from neurologic diseases that could cause neurogenic incontinence.
Patients with significant urogenital or gastrointestinal disease.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The change in the number of micturitions per 24 hours from baseline to the end<br /><br>of the double-blind treatment period.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Number of urge incontinence episodes, number of urgency (without incontinence)<br /><br>episodes, number of incontinence episodes, number of voids (micturitions plus<br /><br>incontinence episodes), number of urgency episodes, number of nocturia<br /><br>episodes, number of continent days and volume of urine passed per void.</p><br>