check_circleStudy Completed

Overactive Bladder, Detrusor Overactivity

Bayer Identifier:

12392

ClinicalTrials.gov Identifier:

NCT00478881

EudraCT Number:

2006-005145-11

EU CT Number:

Not Available
A Study To Assess If 10 mg Vardenafil (BAY38-9456) Taken Twice Daily For 6 Weeks Has An Effect On Bladder Function

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.

Key Participants Requirements

Sex

Both

Age

18 Years
  • - 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
  • - 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
August 2007 - November 2008
Phase
Phase 2
Could I Receive a placebo
Yes
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Universitätsklinikum EssenEssen, 45147, Germany
Completed
Praxis Dr. Stefan Carl & Dr. Achim ForthEmmendingen, 79312, Germany
Completed
Reha-Zentrum Passauer WolfBad Griesbach-Therme, 94086, Germany
Completed
Kliniken Nordoberpfalz AG - Klinikum WeidenWeiden, 92637, Germany
Completed
Praxis Hr. Dr. K.-U. LavalDüsseldorf, 40235, Germany
Completed
Praxis Drs. Roth / WinsWuppertal, 42103, Germany
Completed
Universitätsklinikum Leipzig AöRLeipzig, 04103, Germany
Completed
Asklepios Klinikum UckermarkSchwedt, 16303, Germany
Completed
Städtisches Klinikum Neunkirchen gemeinnützige GmbHNeunkirchen, 66538, Germany
Completed
Hôpital Tenon - ParisPARIS CEDEX 20, 75970, France
Completed
Paris, 75571, France
Completed
Szpital Kliniczny Dzieciatka Jezus -Centrum Leczenia ObrazenWarszawa, 02-005, Poland
Completed
NZOZ Centrum Medyczne WolaWarszawa, 01-432, Poland
Completed
Praxis Fr. Dr. E. HeßdörferBerlin, 13347, Germany
Completed
Kliniken Maria Hilf GmbHMönchengladbach, 41063, Germany
Completed
St. Hedwig KrankenhausBerlin, 10115, Germany
Completed
Klinikum der Ernst-Moritz-Arndt-UniversitätGreifswald, 17475, Germany
Completed
Centrum Leczenia Chorób CywilizacyjnychWarszawa, 02-777, Poland
Completed
Slaskie Centrum Urologii "Urovita"Chorzow, 41-500, Poland
Completed
NZOZ Urolog - Poradnia UrologicznaBydgoszcz, 85-168, Poland
Completed
Uroprojekt s.c. - Gabinet urologicznySiedlce, 08-110, Poland
Completed
Hospital Clínic i Provincial de BarcelonaBarcelona, 08036, Spain
Completed
Ciutat Sanitària i Universitaria de la Vall d'HebronBarcelona, 08035, Spain
Completed
Hospital Universitario "La Paz"Madrid, 28046, Spain
Completed
Hospital Universitario Virgen de las NievesGranada, 18014, Spain
Completed
Hospital Clínico Universitario de Santiago de CompostelaSantiago de Compostela, 15706, Spain
Completed
Urology AssociatesKitchener, N2N 2B9, Canada
Completed
Brantford Urology ResearchBrantford, N3R 4N3, Canada
Completed
Academisch Ziekenhuis MaastrichtMAASTRICHT, 6229 HX, Netherlands
Completed
CatharinaEINDHOVEN, 5623 EJ, Netherlands
Completed
Hospital Clínico Universitario de ValenciaValencia, 46010, Spain
Completed
Sir Mortimer B. Davis Jewish General HospitalMontreal, H3T 1E2, Canada
Completed
Dr. Steinhoff Clinical ResearchVictoria, V8V 3N1, Canada
Completed
CU Saint-Luc/UZ St-LucBRUXELLES - BRUSSEL, 1200, Belgium
Completed
Vrije Universiteit Medisch CentrumAMSTERDAM, 1081 HV, Netherlands
Completed
University Medical Center UtrechtUTRECHT, 3584 CX, Netherlands
Completed
Erasmus Medisch CentrumROTTERDAM, 3015 CE, Netherlands
Completed
Academisch Medisch Centrum Universiteit van AmsterdamAMSTERDAM, 1105 AZ, Netherlands
Completed
Androgeos - private center of urology and andrologyPraha 6, 160 00, Czech Republic
Completed
Fakultni Thomayerova NemocnicePraha 4, 140 59, Czech Republic
Completed
Fakultni Nemocnice OlomoucOlomouc, 775 20, Czech Republic
Completed
Shaare Zedek Medical CenterJerusalem, 91031, Israel
Completed
Porto, 4050-013, Portugal
Completed
S. Martinho do Bispo, 3046-853, Portugal
Completed
Hospital Santo António OportoPorto, 4099-001, Portugal
Completed
Budai Egeszsegkozpont KftBudapest, 1126, Hungary
Completed
Municipal Clinical Hospital N50Moscow, 125206, Russia
Completed
Andros Urological ClinicSt. Petersburg, 198013, Russia
Completed
Research Institute of UrologyMoscow, 105425, Russia
Completed
Universitätsspital BaselBasel, 4031, Switzerland
Completed
Rambam Medical CenterHaifa, 31096, Israel
Completed
Rabin Medical CenterPetach Tikva, Israel
Completed
Amadora, 2720-276, Portugal
Completed
Lisboa, 1069-166, Portugal
Completed
University of SemmelweisBudapest, 1082, Hungary
Completed
Research Institute of UrologyMoscow, 105425, Russia

Primary Outcome

  • Change From Baseline in Bladder Volume at First Detrusor Contraction at 6 Weeks
    date_rangeTime Frame:
    baseline and up to 6 weeks of treatment Last Observation Carried Forward (LOCF)
    enhanced_encryption
    Safety Issue:
    No
  • Change From Baseline in Average Number of Daily Micturitions at 6 Weeks
    date_rangeTime Frame:
    baseline and up to 6 weeks of treatment LOCF
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Change From Baseline in H2O Detrusor Pressure at First Contraction at 6 Weeks
    date_rangeTime Frame:
    baseline and up to 6 weeks of treatment LOCF
    enhanced_encryption
    Safety Issue:
    No
  • Change From Baseline in Volume at First Detectable Leakage at 6 Weeks
    date_rangeTime Frame:
    baseline and up to 6 weeks of treatment LOCF
    enhanced_encryption
    Safety Issue:
    No
  • Change From Baseline in Maximum Cystometric Bladder Capacity at 6 Weeks
    date_rangeTime Frame:
    baseline and up to 6 weeks of treatment LOCF
    enhanced_encryption
    Safety Issue:
    No
  • Change From Baseline in Volume at First Desire to Void at 6 Weeks
    date_rangeTime Frame:
    baseline and up to 6 weeks of treatment LOCF
    enhanced_encryption
    Safety Issue:
    No
  • Change From Baseline in Average Number of Urgencies Per Day at 6 Weeks
    date_rangeTime Frame:
    baseline and up to 6 weeks of treatment LOCF
    enhanced_encryption
    Safety Issue:
    No
  • Change From Baseline in Average Number of Daily Involuntary Discharges of Urine at 6 Weeks
    date_rangeTime Frame:
    baseline and up to 6 weeks of treatment LOCF
    enhanced_encryption
    Safety Issue:
    No
  • Change From Baseline in Peak Urinary Flow at 6 Weeks in Men Aged 50 Years and Older
    date_rangeTime Frame:
    baseline and up to 6 weeks of treatment LOCF
    enhanced_encryption
    Safety Issue:
    No
  • Change From Baseline in the Total Score of the Overactive Bladder Questionnaire (OAB-q) at 6 Weeks
    date_rangeTime Frame:
    baseline and up to 6 weeks of treatment LOCF
    enhanced_encryption
    Safety Issue:
    No

Trial design

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)
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to Bayer Healthcare products.Click here to find information about studies related to Bayer Healthcare products conducted in Europe