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

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00478881

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.

Condition	Intervention	Phase
Overactive Bladder Detrusor Overactivity	Drug: Vardenafil HCl (Levitra, BAY38-9456) Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
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)

Resource links provided by NLM:

MedlinePlus related topics: Urine and Urination

Drug Information available for: Vardenafil Vardenafil dihydrochloride

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Change From Baseline in Bladder Volume at First Detrusor Contraction at 6 Weeks [ Time Frame: baseline and up to 6 weeks of treatment Last Observation Carried Forward (LOCF) ] [ Designated as safety issue: No ]
Bladder volume was measure by means of urodynamic assessments (cystometry) for up to 6 weeks. Missing data were imputed with last observation carried forward (LOCF).
Change From Baseline in Average Number of Daily Micturitions at 6 Weeks [ Time Frame: baseline and up to 6 weeks of treatment LOCF ] [ Designated as safety issue: No ]
Change from baseline in the number of daily micturitions (bladder voidings), as reported in the participant diaries for up to 6 weeks. Missing data were imputed with last observation carried forward (LOCF).

Secondary Outcome Measures:

Change From Baseline in H2O Detrusor Pressure at First Contraction at 6 Weeks [ Time Frame: baseline and up to 6 weeks of treatment LOCF ] [ Designated as safety issue: No ]
Detrusor pressure was measured by means of urodynamic assessment (cystometry) for up to 6 weeks. Missing data were imputed by last observation carried forward (LOCF).
Change From Baseline in Volume at First Detectable Leakage at 6 Weeks [ Time Frame: baseline and up to 6 weeks of treatment LOCF ] [ Designated as safety issue: No ]
First detectable leakage was determined by means of cystometry as an obligatory urodynamic measure. Missing data was imputed by last observation carried forward (LOCF).
Change From Baseline in Maximum Cystometric Bladder Capacity at 6 Weeks [ Time Frame: baseline and up to 6 weeks of treatment LOCF ] [ Designated as safety issue: No ]
Maximum cystometric bladder capacity was defined as the volume at which either significant leakage or discomfort/pain occurred. Missing data were imputed by last observation carried forward (LOCF).
Change From Baseline in Volume at First Desire to Void at 6 Weeks [ Time Frame: baseline and up to 6 weeks of treatment LOCF ] [ Designated as safety issue: No ]
Volume at first desire to void was recorded during urodynamic assessments. Missing data were imputed by last observation carried forward (LOCF).
Change From Baseline in Average Number of Urgencies Per Day at 6 Weeks [ Time Frame: baseline and up to 6 weeks of treatment LOCF ] [ Designated as safety issue: No ]
The average number of urgencies was derived from the number of urgencies reported by the participants in a 7 day micturition diary. Missing data were imputed by last observation carried forward.
Change From Baseline in Average Number of Daily Involuntary Discharges of Urine at 6 Weeks [ Time Frame: baseline and up to 6 weeks of treatment LOCF ] [ Designated as safety issue: No ]
The average number of daily involuntary discharges of urine was derived from the number of discharges reported by the participants in a 7 day micturition diary. Missing data were imputed by last observation carried forward.
Change From Baseline in Peak Urinary Flow at 6 Weeks in Men Aged 50 Years and Older [ Time Frame: baseline and up to 6 weeks of treatment LOCF ] [ Designated as safety issue: No ]
Peak urinary flow (Qmax) was measured using urodynamic assessments (voiding / flow cystometry) for up to 6 weeks. Missing data were imputed by last observation carried forward (LOCF).
Change From Baseline in the Total Score of the Overactive Bladder Questionnaire (OAB-q) at 6 Weeks [ Time Frame: baseline and up to 6 weeks of treatment LOCF ] [ Designated as safety issue: No ]
The OAB-q is a validated, self-administered questionnaire that quantifies bladder symptoms and quality of life. It comprises 33 items (6-point scale for each item). The total score ranges from 33 (minimum symptoms) to 198 (maximum symptoms). On each item, participants provide their rating over the past 4 weeks. Missing data were imputed by LOCF.

Enrollment:	397
Study Start Date:	August 2007
Study Completion Date:	November 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Vardenafil HCl (Levitra, BAY38-9456) vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks	Drug: Vardenafil HCl (Levitra, BAY38-9456) vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
Placebo Comparator: Placebo vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks	Drug: Placebo vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00478881

Show 55 Study Locations

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

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No publications provided

Responsible Party:	Therapeutic Area Head, Bayer Schering Pharma AG
ClinicalTrials.gov Identifier:	NCT00478881 History of Changes
Other Study ID Numbers:	12392, EudraCT: 2006-005145-11
Study First Received:	May 24, 2007
Results First Received:	November 16, 2009
Last Updated:	April 28, 2011
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; Belgium: Directorate general for the protection of Public health: Medicines; Czech Republic: State Institute for Drug Control; Spain: Spanish Agency of Medicines; France: Afssaps - French Health Products Safety Agency; Hungary: National Institute of Pharmacy; Israel: Israeli Health Ministry Pharmaceutical Administration; Italy: The Italian Medicines Agency; Netherlands: Medicines Evaluation Board (MEB); Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Portugal: National Pharmacy and Medicines Institute; Russia: Ministry of Health and Social Development of the Russian Federation

Additional relevant MeSH terms:

Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Vardenafil
Vasodilator Agents

Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012