Official Title: “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, on 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: 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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: August 2008

Intervention(s) in this Clinical Trial

• Drug: Levitra (Vardenafil, BAY38-9456)
  • Vardenafil active substance, tablet, 10 mg, BID, for 6 weeks.
• Drug: Placebo
  • Vardenafil placebo, tablet, 10 mg, BID, for 6 weeks.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Arm 1
• Placebo Comparator: Arm 2

Primary Measures

• Change in bladder volume at first detrusor contraction (urodynamic measurements), co-primary variable: change in number of daily micturitions (patient diaries).
  • Time Frame: at Week 6 (in absolute values)
    Safety Issue?: No

Secondary Measures

• Urodynamic measurements (filling cystometry and pressure flow investigations) at Week 6 vs. baseline: Percent change from baseline in bladder volume at first detrusor contraction
  • Time Frame: at Week 6
    Safety Issue?: No
• Detrusor pressure at first contraction
  • Time Frame: at Week 6
    Safety Issue?: No
• Cystometric bladder compliance
  • Time Frame: at Week 6
    Safety Issue?: No
• Volume at first detectable leakage
  • Time Frame: at Week 6
    Safety Issue?: No
• Maximum cystometric bladder capacity, which is defined as the volume at 40 cm H2O detrusor pressure or significant leakage (i.e. leakage that prevents further volume increase) or discomfort/pain
  • Time Frame: at Week 6
    Safety Issue?: No
• Volume at first desire to void
  • Time Frame: at Week 6
    Safety Issue?: No
• Other secondary efficacy variables:
  • Time Frame: at Week 6
    Safety Issue?: No
• Number of micturitions per day
  • Time Frame: at Week 6
    Safety Issue?: No
• Number of urgency episodes per day
  • Time Frame: at Week 6
    Safety Issue?: No
• Number of incontinence episodes (involuntary discharges of urine) per day
  • Time Frame: at Week 6
    Safety Issue?: No
• In men aged 50 years and older: Peak urinary flow
  • Time Frame: at Week 6
    Safety Issue?: No
• OAB-q
  • Time Frame: at Week 6
    Safety Issue?: No

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 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 egenerative 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Bayer

Overall Clinical Trial Officials and Contacts

Bayer Study Director Study Director Bayer  

Overall Contact: Bayer Clinical Trials Contact  clinical-trials-contact@bayerhealthcare.com

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00478881

Study ID Number: 12392

ClinicalTrials.gov Identifier: NCT00478881

Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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