Trial Condition(s):

Overactive Bladder, Detrusor Overactivity

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

Bayer Identifier:

12392

ClinicalTrials.gov Identifier:

NCT00478881

EudraCT Number:

2006-005145-11

Study Completed

Trial Purpose

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.

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

Trial Summary

Enrollment Goal
397
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
Yes
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Universitätsklinikum Essen

Essen, Germany, 45147

Status
Completed
 
Locations

Praxis Dr. Stefan Carl & Dr. Achim Forth

Emmendingen, Germany, 79312

Status
Completed
 
Locations

Reha-Zentrum Passauer Wolf

Bad Griesbach-Therme, Germany, 94086

Status
Completed
 
Locations

Kliniken Nordoberpfalz AG - Klinikum Weiden

Weiden, Germany, 92637

Status
Completed
 
Locations

Praxis Hr. Dr. K.-U. Laval

Düsseldorf, Germany, 40235

Status
Completed
 
Locations

Praxis Drs. Roth / Wins

Wuppertal, Germany, 42103

Status
Completed
 
Locations

Universitätsklinikum Leipzig AöR

Leipzig, Germany, 04103

Status
Completed
 
Locations

Asklepios Klinikum Uckermark

Schwedt, Germany, 16303

Status
Completed
 
Locations

Städtisches Klinikum Neunkirchen gemeinnützige GmbH

Neunkirchen, Germany, 66538

Status
Completed
 
Locations

Hôpital Tenon - Paris

PARIS CEDEX 20, France, 75970

Status
Completed
 
Locations

Investigative Site

Paris, France, 75571

Status
Completed
 
Locations

Szpital Kliniczny Dzieciatka Jezus -Centrum Leczenia Obrazen

Warszawa, Poland, 02-005

Status
Completed
 
Locations

NZOZ Centrum Medyczne Wola

Warszawa, Poland, 01-432

Status
Completed
 
Locations

Praxis Fr. Dr. E. Heßdörfer

Berlin, Germany, 13347

Status
Completed
 
Locations

Kliniken Maria Hilf GmbH

Mönchengladbach, Germany, 41063

Status
Completed
 
Locations

St. Hedwig Krankenhaus

Berlin, Germany, 10115

Status
Completed
 
Locations

Klinikum der Ernst-Moritz-Arndt-Universität

Greifswald, Germany, 17475

Status
Completed
 
Locations

Centrum Leczenia Chorób Cywilizacyjnych

Warszawa, Poland, 02-777

Status
Completed
 
Locations

Slaskie Centrum Urologii "Urovita"

Chorzow, Poland, 41-500

Status
Completed
 
Locations

NZOZ Urolog - Poradnia Urologiczna

Bydgoszcz, Poland, 85-168

Status
Completed
 
Locations

Uroprojekt s.c. - Gabinet urologiczny

Siedlce, Poland, 08-110

Status
Completed
 
Locations

Hospital Clínic i Provincial de Barcelona

Barcelona, Spain, 08036

Status
Completed
 
Locations

Ciutat Sanitària i Universitaria de la Vall d'Hebron

Barcelona, Spain, 08035

Status
Completed
 
Locations

Hospital Universitario "La Paz"

Madrid, Spain, 28046

Status
Completed
 
Locations

Hospital Universitario Virgen de las Nieves

Granada, Spain, 18014

Status
Completed
 
Locations

Hospital Clínico Universitario de Santiago de Compostela

Santiago de Compostela, Spain, 15706

Status
Completed
 
Locations

Urology Associates

Kitchener, Canada, N2N 2B9

Status
Completed
 
Locations

Brantford Urology Research

Brantford, Canada, N3R 4N3

Status
Completed
 
Locations

Academisch Ziekenhuis Maastricht

MAASTRICHT, Netherlands, 6229 HX

Status
Completed
 
Locations

Catharina

EINDHOVEN, Netherlands, 5623 EJ

Status
Completed
 
Locations

Hospital Clínico Universitario de Valencia

Valencia, Spain, 46010

Status
Completed
 
Locations

Sir Mortimer B. Davis Jewish General Hospital

Montreal, Canada, H3T 1E2

Status
Completed
 
Locations

Dr. Steinhoff Clinical Research

Victoria, Canada, V8V 3N1

Status
Completed
 
Locations

CU Saint-Luc/UZ St-Luc

BRUXELLES - BRUSSEL, Belgium, 1200

Status
Completed
 
Locations

Vrije Universiteit Medisch Centrum

AMSTERDAM, Netherlands, 1081 HV

Status
Completed
 
Locations

University Medical Center Utrecht

UTRECHT, Netherlands, 3584 CX

Status
Completed
 
Locations

Erasmus Medisch Centrum

ROTTERDAM, Netherlands, 3015 CE

Status
Completed
 
Locations

Academisch Medisch Centrum Universiteit van Amsterdam

AMSTERDAM, Netherlands, 1105 AZ

Status
Completed
 
Locations

Androgeos - private center of urology and andrology

Praha 6, Czech Republic, 160 00

Status
Completed
 
Locations

Fakultni Thomayerova Nemocnice

Praha 4, Czech Republic, 140 59

Status
Completed
 
Locations

Fakultni Nemocnice Olomouc

Olomouc, Czech Republic, 775 20

Status
Completed
 
Locations

Shaare Zedek Medical Center

Jerusalem, Israel, 91031

Status
Completed
 
Locations

Investigative Site

Porto, Portugal, 4050-013

Status
Completed
 
Locations

Investigative Site

S. Martinho do Bispo, Portugal, 3046-853

Status
Completed
 
Locations

Hospital Santo António Oporto

Porto, Portugal, 4099-001

Status
Completed
 
Locations

Budai Egeszsegkozpont Kft

Budapest , Hungary, 1126

Status
Completed
 
Locations

Municipal Clinical Hospital N50

Moscow, Russia, 125206

Status
Completed
 
Locations

Andros Urological Clinic

St. Petersburg, Russia, 198013

Status
Completed
 
Locations

Research Institute of Urology

Moscow, Russia, 105425

Status
Completed
 
Locations

Universitätsspital Basel

Basel, Switzerland, 4031

Status
Completed
 
Locations

Rambam Medical Center

Haifa, Israel, 31096

Status
Completed
 
Locations

Rabin Medical Center

Petach Tikva, Israel

Status
Completed
 
Locations

Investigative Site

Amadora, Portugal, 2720-276

Status
Completed
 
Locations

Investigative Site

Lisboa, Portugal, 1069-166

Status
Completed
 
Locations

University of Semmelweis

Budapest, Hungary, 1082

Status
Completed
 

Trial Design