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Overactive BladderPhase 2NCT00478881

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

A Phase 2 study testing Vardenafil HCl (Levitra, BAY38-9456) in people with Overactive Bladder and Detrusor Overactivity, run by Bayer at 55 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Overactive Bladder, Detrusor Overactivity
What is being tested?
Vardenafil HCl (Levitra, BAY38-9456)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
397 participants
Where
55 sitesin 13 countries
Study dates
Aug 2007to Nov 2008
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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 locations and contacts

55 sites in 13 countries.

55 sites in 13 countries

Germany13 sites

  • Study site

    Bad Griesbach-Therme, Bavaria, 94086

  • Study site

    Berlin, State of Berlin, 10115

  • Study site

    Berlin, State of Berlin, 13347

  • Study site

    Düsseldorf, North Rhine-Westphalia, 40235

  • Study site

    Emmendingen, Baden-Wurttemberg, 79312

  • Study site

    Essen, North Rhine-Westphalia, 45147

  • Study site

    Greifswald, Mecklenburg-Vorpommern, 17475

  • Study site

    Leipzig, Saxony, 04103

  • Study site

    Mönchengladbach, North Rhine-Westphalia, 41063

  • Study site

    Neunkirchen, Saarland, 66538

  • Study site

    Schwedt, Brandenburg, 16303

  • Study site

    Weiden, Bavaria, 92637

  • Study site

    Wuppertal, North Rhine-Westphalia, 42103

Other trials in Germany

Netherlands6 sites

  • Study site

    Amsterdam, 1081 HV

  • Study site

    Amsterdam, 1105 AZ

  • Study site

    Eindhoven, North Brabant, 5623 EJ

  • Study site

    Maastricht, 6229 HX

  • Study site

    Rotterdam, 3015 CE

  • Study site

    Utrecht, 3584 CX

Other trials in Netherlands

Poland6 sites

  • Study site

    Bydgoszcz, 85-168

  • Study site

    Chorzów, 41-500

  • Study site

    Siedlce, 08-110

  • Study site

    Warsaw, 01-432

  • Study site

    Warsaw, 02-005

  • Study site

    Warsaw, 02-777

Other trials in Poland

Spain6 sites

  • Study site

    Barcelona, Barcelona, 08035

  • Study site

    Barcelona, Barcelona, 08036

  • Study site

    Granada, Granada, 18014

  • Study site

    Madrid, Madrid, 28046

  • Study site

    Santiago de Compostela, A Coruña, 15706

  • Study site

    Valencia, Valencia, 46010

Other trials in Spain

Portugal5 sites

  • Study site

    Amadora, 2720-276

  • Study site

    Lisbon, 1069-166

  • Study site

    Porto, 4050-013

  • Study site

    Porto, 4099-001

  • Study site

    S. Martinho Do Bispo, 3046-853

Other trials in Portugal

Canada4 sites

  • Study site

    Brantford, Ontario, N3R 4N3

  • Study site

    Kitchener, Ontario, N2N 2B9

  • Study site

    Montreal, Quebec, H3T 1E2

  • Study site

    Victoria, British Columbia, V8V 3N1

Other trials in Canada

Czechia3 sites

  • Study site

    Olomouc, 775 20

  • Study site

    Prague, 140 59

  • Study site

    Prague, 160 00

Other trials in Czechia

Israel3 sites

  • Study site

    Haifa, Israel, 31096

  • Study site

    Jerusalem, Israel, 91031

  • Study site

    Petah Tikva, Israel

Other trials in Israel

Russia3 sites

  • Study site

    Moscow, 105425

  • Study site

    Moscow, 125206

  • Study site

    Saint Petersburg, 198013

Other trials in Russia

France2 sites

  • Study site

    Paris, 75571

  • Study site

    Paris, 75970

Other trials in France

Hungary2 sites

  • Study site

    Budapest, 1082

  • Study site

    Budapest, 1126

Other trials in Hungary

Belgium1 site

  • Study site

    Bruxelles - Brussel, 1200

Other trials in Belgium

Switzerland1 site

  • Study site

    Basel, Canton of Basel-City, 4031

Other trials in Switzerland

About this study

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)

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.

Being tested
Vardenafil HCl (Levitra, BAY38-9456), Placebo
Medical subject headings
Urinary Bladder, Overactive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vardenafil HCl (Levitra, BAY38-9456)Drug

    vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks

  • PlaceboDrug

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

Study groups in NCT00478881
Study groupRoleWhat they receive
Vardenafil HCl (Levitra, BAY38-9456)Experimentalvardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
Receives: Drug: Vardenafil HCl (Levitra, BAY38-9456)
PlaceboPlacebo comparatorvardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: baseline and up to 6 weeks of treatment Last Observation Carried Forward (LOCF)

  2. 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).

    Measured: baseline and up to 6 weeks of treatment LOCF

Secondary outcomes (8)

  1. 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).

    Measured: baseline and up to 6 weeks of treatment LOCF

  2. 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).

    Measured: baseline and up to 6 weeks of treatment LOCF

  3. 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).

    Measured: baseline and up to 6 weeks of treatment LOCF

  4. 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).

    Measured: baseline and up to 6 weeks of treatment LOCF

  5. 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.

    Measured: baseline and up to 6 weeks of treatment LOCF

  6. 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.

    Measured: baseline and up to 6 weeks of treatment LOCF

  7. 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).

    Measured: baseline and up to 6 weeks of treatment LOCF

  8. 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.

    Measured: baseline and up to 6 weeks of treatment LOCF

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2007 (estimated)
  2. Study startAug 2007
  3. Primary completionNov 2008
  4. Study completionNov 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
397 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00478881
Sponsor's protocol ID
12392
Other IDs
2006-005145-11
Status last verified
Nov 2014
First submitted
24 May 2007
Last updated
11 Dec 2014
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vardenafil HCl (Levitra, BAY38-9456) in people with Overactive Bladder and Detrusor Overactivity, run by Bayer at 55 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 55 sites in Germany, Netherlands, Poland, Spain, Portugal and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Dec 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00478881.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2014.

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