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Randomized, Double-blind, Placebo-controlled, Parallel Group Study of Vardenafil 10 mg Twice Daily to Assess the Effect on Urodynamics in Patients With Overactive Bladder (Detrusor Overactivity)
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.
Details
| Lead sponsor | Bayer |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 397 |
| Start date | 2007-08 |
| Completion | 2008-11 |
Conditions
- Overactive Bladder
- Detrusor Overactivity
Interventions
- Vardenafil HCl (Levitra, BAY38-9456)
- Placebo
Primary outcomes
- Change From Baseline in Bladder Volume at First Detrusor Contraction at 6 Weeks — baseline and up to 6 weeks of treatment Last Observation Carried Forward (LOCF)
Bladder volume was measure by means of urodynamic assessments (cystometry) for up to 6 weeks. Missing data were imputed with last observation carried forward (LOCF). - Change From Baseline in Average Number of Daily Micturitions at 6 Weeks — baseline and up to 6 weeks of treatment LOCF
Change from baseline in the number of daily micturitions (bladder voidings), as reported in the participant diaries for up to 6 weeks. Missing data were imputed with last observation carried forward (LOCF).
Countries
Belgium, Canada, Czechia, France, Germany, Hungary, Israel, Netherlands, Poland, Portugal, Russia, Spain, Switzerland