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.
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 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
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com
BRUXELLES - BRUSSEL 1200, Belgium; Completed
Ostrava 708 52, Czech Republic; Terminated
Praha 6 160 00, Czech Republic; Completed
Praha 4 140 59, Czech Republic; Completed
Olomouc 775 20, Czech Republic; Completed
Praha 6 169 02, Czech Republic; Terminated
PARIS 75020, France; Active, not recruiting
Budapest 1126, Hungary; Completed
Budapest 1089, Hungary; Completed
Budapest 1106, Hungary; Terminated
Haifa 31096, Israel; Completed
Jerusalem 91031, Israel; Completed
Petach Tikva, Israel; Completed
Tel Hashomer 52621, Israel; Terminated
Verona 37136, Italy; Terminated
Bari 70124, Italy; Terminated
Firenze 50139, Italy; Terminated
Messina 98122, Italy; Terminated
Udine 33100, Italy; Terminated
Padova 35128, Italy; Terminated
Perugia 06122, Italy; Terminated
AMSTERDAM 1081 HV, Netherlands; Completed
MAASTRICHT 6229 HX, Netherlands; Completed
UTRECHT 3584 CX, Netherlands; Completed
ROTTERDAM 3015 GD, Netherlands; Completed
AMSTERDAM 1105 AZ, Netherlands; Completed
LEIDEN 2333 ZA, Netherlands; Terminated
Warszawa 02-032, Poland; Completed
Warszawa 01-432, Poland; Completed
Warszawa 02-777, Poland; Completed
Chorzow 41-500, Poland; Completed
Bydgoszcz 85-168, Poland; Completed
Siedlce 08-110, Poland; Recruiting
Gdynia 81-366, Poland; Terminated
Porto 4099-001, Portugal; Completed
Moscow 127206, Russian Federation; Completed
Moscow 105425, Russian Federation; Completed
St. Petersburg 198013, Russian Federation; Completed
Nizhny Novgorod 603033, Russian Federation; Terminated
Barcelona 08036, Spain; Completed
Barcelona 08035, Spain; Active, not recruiting
Barcelona 08024, Spain; Terminated
Granada 18014, Spain; Completed
Madrid 28046, Spain; Completed
Sevilla 41014, Spain; Terminated
Valencia 46010, Spain; Completed
Basel 4031, Switzerland; Completed
Santiago de Compostela, A Coruña 15706, Spain; Completed
Calgary, Alberta T2V 4R6, Canada; Terminated
Edmonton, Alberta T5H 4B9, Canada; Terminated
Emmendingen, Baden-Württemberg / 274 79312, Germany; Completed
Sigmaringen, Baden-Württemberg / 277 72488, Germany; Terminated
Bad Griesbach-Therme, Bayern / 280 94086, Germany; Completed
Weiden, Bayern / 280 92637, Germany; Completed
Berlin, Berlin / 285 13347, Germany; Completed
Berlin, Berlin / 285 10115, Germany; Completed
Schwedt, Brandenburg / 308 16303, Germany; Active, not recruiting
Victoria, British Columbia V8R 6T9, Canada; Terminated
Victoria, British Columbia V8V 3N1, Canada; Completed
Kelowna, British Columbia V1Y 2H4, Canada; Terminated
Greifswald, Mecklenburg-Vorpommern / 309 17489, Germany; Completed
EINDHOVEN, Noord Brabant 5623 EJ, Netherlands; Completed
Düsseldorf, Nordrhein-Westfalen / 296 40235, Germany; Completed
Essen, Nordrhein-Westfalen / 481 45147, Germany; Completed
Wuppertal, Nordrhein-Westfalen / 616 42103, Germany; Completed
Mönchengladbach, Nordrhein-Westfalen / 618 41063, Germany; Completed
Halifax, Nova Scotia B3H 3A7, Canada; Terminated
Kitchener, Ontario N2N 2B9, Canada; Completed
Barrie, Ontario L4M 4S5, Canada; Terminated
Brantford, Ontario N3R 4N3, Canada; Completed
Montreal, Quebec H3T 1E2, Canada; Active, not recruiting
Granby, Quebec J2G 8Z9, Canada; Terminated
Neunkirchen, Saarland / 305 66538, Germany; Completed
Leipzig, Sachsen / 313 04103, Germany; Completed
