Conditions: Overactive Bladder Detrusor Overactivity
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 397
Healthy volunteers: no

Brief summary:
The purpose of this study is to assess if the study drug, Vardenafil (approved by Health Authorities is available on the market for treatment of erectile dysfunction) has an effect on bladder function and micturition frequency. The study drug is to be taken in the form of tablets twice a day, one tablet in the morning and one tablet in the evening. A non-active treatment (placebo), a sugar pill, will be used as a comparator to see if the new study drug works better than no drug. The timing of visits for the study is as follows: the 1st visit (screening visit) at beginning of run-in-assessment with qualifying tests for patients: electrocardiogram (ECG), safety laboratory and residual urine (by ultrasonography: a non-invasive examination using ultrasound for the assessment of the bladder). 2nd visit (randomization visit). During visit this should be performed: urodynamic measurements (filling cystometry and pressure flow investigations), ECG and safety laboratory. 3rd visit (safety visit) takes place at two up to three weeks of randomized treatment. 4th visit (final visit)-following test should be done: urodynamic measurements (filling cystometry and pressure flow investigations), ECG, safety laboratory and residual urine (by ultrasonography); A phone call 24 hours after visit 4 to assess any SAEs.

Detailed description:

Arms:
arm 1: vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks arm 2: vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks

Interventions: intervention 1: Vardenafil HCl (Levitra, BAY38-9456) intervention 2: Placebo
Intervention descriptions: intervention 1: vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks intervention 2: vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks

Protocol document: