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

This is an interventional treatment trial for Overactive Bladder Read More

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