A Study To Assess If 10 mg Vardenafil (BAY38-9456) Taken Twice Daily For 6 Weeks Has An Effect On Bladder Function
Condition: Overactive Bladder; Detrusor Overactivity
MeSH terms: Urinary Bladder, Overactive
Intervention: Vardenafil HCl (Levitra, BAY38-9456); Placebo
Intervention description: vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks; vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
Intervention MeSH terms: Vardenafil Dihydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 397.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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