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

Overactive Bladder Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00478881
• Other study ID #: 12392
• Secondary ID: 2006-005145-11
• Status: Completed
• Phase: Phase 2
• First received: May 24, 2007
• Last updated: November 24, 2014
• Start date: August 2007
• Est. completion date: November 2008

Study information

• Verified date: November 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesBelgium: Federal Agency for Medicines and Health Products, FAMHPCzech Republic: State Institute for Drug ControlSpain: Spanish Agency of MedicinesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Hungary: National Institute of PharmacyIsrael: Israeli Health Ministry Pharmaceutical AdministrationItaly: The Italian Medicines AgencyNetherlands: Medicines Evaluation Board (MEB)Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsPortugal: National Pharmacy and Medicines InstituteRussia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 397
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Detrusor Overactivity
• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

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
vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Belgium,  Canada,  Czech Republic,  France,  Germany,  Hungary,  Israel,  Netherlands,  Poland,  Portugal,  Russian Federation,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Bladder Volume at First Detrusor Contraction at 6 Weeks	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).	baseline and up to 6 weeks of treatment Last Observation Carried Forward (LOCF)	No
Primary	Change From Baseline in Average Number of Daily Micturitions at 6 Weeks	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).	baseline and up to 6 weeks of treatment LOCF	No
Secondary	Change From Baseline in H2O Detrusor Pressure at First Contraction at 6 Weeks	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).	baseline and up to 6 weeks of treatment LOCF	No
Secondary	Change From Baseline in Volume at First Detectable Leakage at 6 Weeks	First detectable leakage was determined by means of cystometry as an obligatory urodynamic measure. Missing data was imputed by last observation carried forward (LOCF).	baseline and up to 6 weeks of treatment LOCF	No
Secondary	Change From Baseline in Maximum Cystometric Bladder Capacity at 6 Weeks	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).	baseline and up to 6 weeks of treatment LOCF	No
Secondary	Change From Baseline in Volume at First Desire to Void at 6 Weeks	Volume at first desire to void was recorded during urodynamic assessments. Missing data were imputed by last observation carried forward (LOCF).	baseline and up to 6 weeks of treatment LOCF	No
Secondary	Change From Baseline in Average Number of Urgencies Per Day at 6 Weeks	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.	baseline and up to 6 weeks of treatment LOCF	No
Secondary	Change From Baseline in Average Number of Daily Involuntary Discharges of Urine at 6 Weeks	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.	baseline and up to 6 weeks of treatment LOCF	No
Secondary	Change From Baseline in Peak Urinary Flow at 6 Weeks in Men Aged 50 Years and Older	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).	baseline and up to 6 weeks of treatment LOCF	No
Secondary	Change From Baseline in the Total Score of the Overactive Bladder Questionnaire (OAB-q) at 6 Weeks	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.	baseline and up to 6 weeks of treatment LOCF	No

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