A Study To Assess If 10 mg Vardenafil (BAY38-9456) Taken Twice Daily For 6 Weeks Has An Effect On Bladder Function

Bayer

Status and phase

Completed

Phase 2

Conditions

Detrusor Overactivity

Overactive Bladder

Treatments

Drug: Vardenafil HCl (Levitra, BAY38-9456)

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00478881

2006-005145-11 (EudraCT Number)

12392

Details and patient eligibility

About

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.

Enrollment

397 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male and female patients aged > 18 years (females either postmenopausal or using adequate birth control)
Urodynamic criteria:
- Entire bladder capacity (= maximum cystometric bladder capacity) < 300 mL OR
- In accordance with International Continence Society (ICS)-guidelines: Detrusor overactivity as defined as spontaneous involuntary detrusor contraction during filling phase OR
- Detrusor contraction during filling phase leading to involuntarily initiated micturition before a normal bladder capacity is reached
Patient micturition diary criteria: at least 8 micturitions per day AND at least 1 urgency episode per day
Signed and dated written Patient Informed Consent Form

Exclusion criteria

Treatment with drugs known to affect urinary bladder function
Known other reasons for micturition problems than detrusor overactivity
Recent intervention in urogenital tract
Abnormal liver or renal lab values
Treatment with nitrates or nitric oxide donors, alpha-blockers, potent inhibitors of CYP-450 3A4, acenocoumarol, heparin, drugs known to prolong QT-interval
NAION, hereditary regenerative retinal disorders, severe cardiovascular conditions, recent history of myocardial infarction/stroke/life-threatening arrhythmia
congenital QT-prolongation, left ventricular outflow obstruction, severe hypo- or hypertension, symptomatic postural hypotension
History of positive test for Hepatitis B surface antigen (HBsAg) or Hepatitis C
Significant active peptic ulceration
Severe chronic or acute liver disease, history of moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment
In men: Clinically significant chronic haematological disease which may lead to priapism
History of malignancy of any organ system within the past 5 years
Bleeding disorder