Urinary IncontinencePhase 4NCT00127270
Using Behavioral Therapy in Combination With Darifenacin for Symptoms of Overactive Bladder
A Phase 4 study testing Darifenacin and Behavioral therapy in people with Urinary Incontinence, run by Novartis at 67 sites in United States.
Trial summary
This study is designed to investigate the efficacy and safety of treatment of overactive bladder with darifenacin administered alone or in conjunction with behavioral modification therapies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Darifenacin and Behavioral therapy
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 395 participants
- Where
- 67 sitesUnited States
- Study dates
- May 2005to Feb 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Who may be able to join
- Symptoms of overactive bladder
- Capable of independent toileting and completing a micturition diary
- Able to comprehend English and follow study procedures and instructions
Who cannot join
- Post void residual > 100ml/sec
- Urine flow rate (Qmax) <10ml/sec for males only
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
67 sites in 1 country.
67 sites in 1 country
United States67 sites
Atlanta Medical Research Institute
Alpharetta, Georgia, 30005
Shepard Center
Atlanta, Georgia, 30309
Urology Research Options
Aurora, Colorado, 80012
South Florida Medical Research
Aventura, Florida, 33180
Alabama Research Center
Birmingham, Alabama, 35209
Progressive Clinical Research
Centerville, Utah, 84014
South Carolina Clinical Research Center
Columbia, South Carolina, 29201
Northeast Urology Research
Concord, North Carolina, 28025
Medical Arts Clinic
Corsicana, Texas, 75110
UCLA - Urology Sciences Research Foundation
Culver City, California, 90232
Radiant Research
Dallas, Texas, 75231
Urology Clinics of North Texas
Dallas, Texas, 75231
Private Practice
Edmond, Oklahoma, 73034
Welborn Clinic
Evansville, Indiana, 47714
Deerpath Physicians Group
Gurnee, Illinois, 60031
Advances in Health
Houston, Texas, 77030
Kelsey Seybold Research Foundation
Houston, Texas, 77054
Urology of Indiana
Indianapolis, Indiana, 46254
Mississippi Urology Clinical Research
Jackson, Mississippi, 39202
Metropolitan Urology
Jeffersonville, Indiana, 47130
San Diego Center for Urology Care
La Mesa, California, 91942
Orange County Urology Associates
Laguna Woods, California, 92653
R/D Clinical Research
Lake Jackson, Texas, 77566
Radiant Research
Lakewood, Washington, 98499
Lawrenceville Urology
Lawrenceville, New Jersey, 08648
Women's Clinic of Lincoln
Lincoln, Nebraska, 68510
Atlantic Urology Medical Group
Long Beach, California, 90806
Central New York Clinical Research
Manlius, New York, 13104
Southern Oregon Health and Wellness
Medford, Oregon, 97504
RMD Clinical Research Institute
Melrose Park, Illinois, 60160
Doctors for Women
Nashville, Tennessee, 37203
Advance Research Institute
New Port Richey, Florida, 34652
California Professional Research
Newport Beach, California, 92660
Private Practice
North Hollywood, California, 91607
Southern Illinois Clinical Research Center
O'Fallon, Illinois, 62269
Florida Healthcare Research
Ocala, Florida, 34474
Quality Clinical Research
Omaha, Nebraska, 68131
Meridian Clinical Research
Omaha, Nebraska, 68134
Winter Park Urology Associates
Orlando, Florida, 32803
Urologic Surgery Associates
Overland Park, Kansas, 66215
Univ. of Pittsburgh Medical Center- Dept of Urology
Pittsburgh, Pennsylvania, 15213
Research Protocol Management Specialists
Pittsburgh, Pennsylvania, 15243
Portland Clinic
Portland, Oregon, 97205
Hudson Valley Urology
Poughkeepsie, New York, 12601
Pratt Internal Medicine Group
Pratt, Kansas, 67124
Multi Specialty Research Associates of NC
Raleigh, North Carolina, 27609
Valley Women's Clinic
Renton, Washington, 98055
Virginia Urology
Richmond, Virginia, 23235
Adult and Pediatric Urology
Saint Cloud, Minnesota, 56303
Intermountain Clinical Research
Salt Lake City, Utah, 84102
Salt Lake Research
Salt Lake City, Utah, 84124
Medical Center for Clinical Research
San Diego, California, 92108
Encompass Clinical Research
Spring Valley, California, 91978
Springfield Clinic
Springfield, Illinois, 62701
PPS Clinical Research
St Louis, Missouri, 63141
Washing Univ School of Medicine - Urologic Research Center
St Louis, Missouri, 63141
Jacobi Medical Center
The Bronx, New York, 10461
Cotton-O'Neil Clinic
Topeka, Kansas, 66606
Western Clinical Research
Torrance, California, 90505
Williamette Women's Health
Tualatin, Oregon, 97232
Quality of Life Medical & Research
Tucson, Arizona, 85712
East Coast Clinical Research
Virginia Beach, Virginia, 23454
Center for Urologic Care
Voorhees Township, New Jersey, 08043
Connecticut Clinical Research Center
Waterbury, Connecticut, 06708
Western Urologic Associates
Wheat Ridge, Colorado, 80033
Hearthland Research Associates
Wichita, Kansas, 67207
Piedmont Medical Research Associates
Winston-Salem, North Carolina, 27103
About this study
Official title: Using Behavioral Therapy in Combination With Drug-Darifenacin for Symptoms of Overactive Bladder
This study is designed to investigate the efficacy and safety of treatment of overactive bladder with darifenacin administered alone or in conjunction with behavioral modification therapies.
- Conditions
- Urinary Incontinence
- Being tested
- Darifenacin, Behavioral therapy
- Keywords
- OAB, Overactive Bladder, Bladder hyperactivity, Urge Incontinence, Incontinence, Bladder
- Medical subject headings
- Urinary Incontinence, Urinary Bladder, Overactive, Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DarifenacinDrug
Also called Enablex
Darifenacin tablets 7,5 mg once daily with the possibility to up-titrate to 15 mg once daily
DarifenacinDrug
Darifenacin tablets 7,5 mg or 15 mg once daily
Behavioral therapyBehavioural
Behavioral Modification Programme for symptoms of overactive bladder
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Darifenacin Receives: Drug: Darifenacin |
| 2 | Other | Darifenacin in combination with Behavioral Modification Programme for Symptoms of Overactive Bladder Receives: Drug: Darifenacin; Behavioral: Behavioral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in average number of urinations per patient per day at Week 12
Secondary outcomes (3)
Change from baseline in average number of urination episodes per patient per day at Week 2, Week 6
Change from baseline in average number of urge urinary incontinence episodes, urgency episodes, incontinence pads, and nocturnal urinations per day measured at Weeks 2, 6, 12
Quality of Life (baseline, Week 6, Week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2005 (estimated)
- Study startMay 2005
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 395 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Procter and Gamble
- Investigators
- Novartis Pharmaceuticals Corp., Study director, Novartis Pharmaceutical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00127270
- Sponsor's protocol ID
- CDAR328AUS01
- Status last verified
- Jan 2008
- First submitted
- 30 Jun 2005
- Last updated
- 24 Jan 2008
- Results posted
- No
Publications
Funada S, Yoshioka T, Luo Y, Sato A, Akamatsu S, Watanabe N. Bladder training for treating overactive bladder in adults. Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD013571. doi: 10.1002/14651858.CD013571.pub2.
PubMed 37811598
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Behavioral Therapy in Combination With Drug-Darifenacin for Symptoms of Overactive Bladder
- ClinicalTrials.gov ID
- NCT00127270
- Acronym / sponsor ID
- CDAR328AUS01
- Conditions
- Urinary Incontinence
- Keywords
- OAB, Overactive Bladder, Bladder hyperactivity, Urge Incontinence, Incontinence, Bladder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 395 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Collaborators
- Procter and Gamble
- Study start
- May 2005
- Study completion
- Feb 2006 (actual)
- First posted
- 5 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to investigate the efficacy and safety of treatment of overactive bladder with darifenacin administered alone or in conjunction with behavioral modification therapies.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: DarifenacinDarifenacin |
| 2 | Other | Drug: Darifenacin, Behavioral: Behavioral therapyDarifenacin in combination with Behavioral Modification Programme for Symptoms of Overactive Bladder |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Symptoms of overactive bladder
- Capable of independent toileting and completing a micturition diary
- Able to comprehend English and follow study procedures and instructions
Key exclusion criteria (3 listed)
- Post void residual > 100ml/sec
- Urine flow rate (Qmax) <10ml/sec for males only
- Other protocol-defined inclusion/exclusion criteria may apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DarifenacinAlso: EnablexDarifenacin tablets 7,5 mg once daily with the possibility to up-titrate to 15 mg once daily | Drug | 1 |
| DarifenacinDarifenacin tablets 7,5 mg or 15 mg once daily | Drug | 2 |
| Behavioral therapyBehavioral Modification Programme for symptoms of overactive bladder | Behavioural | 2 |
Primary outcome
Change from baseline in average number of urinations per patient per day at Week 12
3 secondary outcomes
Change from baseline in average number of urination episodes per patient per day at Week 2, Week 6
Change from baseline in average number of urge urinary incontinence episodes, urgency episodes, incontinence pads, and nocturnal urinations per day measured at Weeks 2, 6, 12
Quality of Life (baseline, Week 6, Week 12)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2008.
- Derived from this study: PubMed 37811598Funada S, Yoshioka T, Luo Y, Sato A, Akamatsu S, Watanabe N. Bladder training for treating overactive bladder in adults. Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD013571. doi: 10.1002/14651858.CD013571.pub2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals Corp. study director
Novartis Pharmaceutical
67 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Darifenacin and Behavioral therapy in people with Urinary Incontinence, run by Novartis at 67 sites in United States.
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 3 inclusion and 3 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 24 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 67 sites in United States. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 average number of urinations per patient per day at Week 12. 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 NCT00127270, which also lists 1 linked publication.
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 24 Jan 2008.