Clinical trial NCT00478881: A Study To Assess If 10 mg Vardenafil (BAY38-9456) Taken Twice Daily For 6 Weeks Has An Effect On Bladder Function
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Overactive Bladder
Detrusor Overactivity
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2007-05-25
Enrollment: 397
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Change From Baseline in Bladder Volume at First Detrusor Contraction at 6 Weeks
timeFrame: baseline and up to 6 weeks of treatment Last Observation Carried Forward (LOCF)
measure: Change From Baseline in Average Number of Daily Micturitions at 6 Weeks
timeFrame: baseline and up to 6 weeks of treatment LOCF
Secondary outcomes:
measure: Change From Baseline in H2O Detrusor Pressure at First Contraction at 6 Weeks
timeFrame: baseline and up to 6 weeks of treatment LOCF
measure: Change From Baseline in Volume at First Detectable Leakage at 6 Weeks
timeFrame: baseline and up to 6 weeks of treatment LOCF
measure: Change From Baseline in Maximum Cystometric Bladder Capacity at 6 Weeks
timeFrame: baseline and up to 6 weeks of treatment LOCF
measure: Change From Baseline in Volume at First Desire to Void at 6 Weeks
timeFrame: baseline and up to 6 weeks of treatment LOCF
measure: Change From Baseline in Average Number of Urgencies Per Day at 6 Weeks
timeFrame: baseline and up to 6 weeks of treatment LOCF
measure: Change From Baseline in Average Number of Daily Involuntary Discharges of Urine at 6 Weeks
timeFrame: baseline and up to 6 weeks of treatment LOCF
measure: Change From Baseline in Peak Urinary Flow at 6 Weeks in Men Aged 50 Years and Older
timeFrame: baseline and up to 6 weeks of treatment LOCF
measure: Change From Baseline in the Total Score of the Overactive Bladder Questionnaire (OAB-q) at 6 Weeks
timeFrame: baseline and up to 6 weeks of treatment LOCF
Other outcomes:
Locations:
city: Bruxelles - Brussel
country: Belgium
city: Victoria
country: Canada
state: British Columbia
city: Brantford
country: Canada
state: Ontario
city: Kitchener
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Olomouc
country: Czech Republic
city: Praha 4
country: Czech Republic
city: Praha 6
country: Czech Republic
city: Paris Cedex 20
country: France
city: Paris
country: France
city: Emmendingen
country: Germany
state: Baden-Württemberg
city: Bad Griesbach-Therme
country: Germany
state: Bayern
city: Weiden
country: Germany
state: Bayern
city: Schwedt
country: Germany
state: Brandenburg
city: Greifswald
country: Germany
state: Mecklenburg-Vorpommern
city: Düsseldorf
country: Germany
state: Nordrhein-Westfalen
city: Essen
country: Germany
state: Nordrhein-Westfalen
city: Mönchengladbach
country: Germany
state: Nordrhein-Westfalen
city: Wuppertal
country: Germany
state: Nordrhein-Westfalen
city: Neunkirchen
country: Germany
state: Saarland
city: Leipzig
country: Germany
state: Sachsen
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Haifa
country: Israel
city: Jerusalem
country: Israel
city: Petach Tikva
country: Israel
city: Eindhoven
country: Netherlands
state: Noord-Brabant
city: Amsterdam
country: Netherlands
city: Amsterdam
country: Netherlands
city: Maastricht
country: Netherlands
city: Rotterdam
country: Netherlands
city: Utrecht
country: Netherlands
city: Bydgoszcz
country: Poland
city: Chorzow
country: Poland
city: Siedlce
country: Poland
city: Warszawa
country: Poland
city: Warszawa
country: Poland
city: Warszawa
country: Poland
city: Amadora
country: Portugal
city: Lisboa
country: Portugal
city: Porto
country: Portugal
city: Porto
country: Portugal
city: S. Martinho do Bispo
country: Portugal
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Santiago de Compostela
country: Spain
state: A Coruña
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Granada
country: Spain
city: Madrid
country: Spain
city: Valencia
country: Spain
city: Basel
country: Switzerland
state: Basel-Stadt
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: