Using Behavioral Therapy in Combination With Darifenacin for Symptoms of Overactive Bladder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00127270
Recruitment Status : Completed
First Posted : August 5, 2005
Last Update Posted : January 24, 2008
Procter and Gamble
Information provided by:

Brief 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.

Condition or disease Intervention/treatment Phase
Urinary Incontinence Drug: Darifenacin Behavioral: Behavioral therapy Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 395 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Using Behavioral Therapy in Combination With Drug-Darifenacin for Symptoms of Overactive Bladder
Study Start Date : May 2005
Actual Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Drug: Darifenacin
Darifenacin tablets 7,5 mg once daily with the possibility to up-titrate to 15 mg once daily
Other Name: Enablex
Darifenacin in combination with Behavioral Modification Programme for Symptoms of Overactive Bladder
Drug: Darifenacin
Darifenacin tablets 7,5 mg or 15 mg once daily
Behavioral: Behavioral therapy
Behavioral Modification Programme for symptoms of overactive bladder

Primary Outcome Measures :
  1. Change from baseline in average number of urinations per patient per day at Week 12

Secondary Outcome Measures :
  1. Change from baseline in average number of urination episodes per patient per day at Week 2, Week 6
  2. 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
  3. Quality of Life (baseline, Week 6, Week 12)

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • Symptoms of overactive bladder
  • Capable of independent toileting and completing a micturition diary
  • Able to comprehend English and follow study procedures and instructions

Exclusion Criteria:

  • Post void residual > 100ml/sec
  • Urine flow rate (Qmax) <10ml/sec for males only

Other protocol-defined inclusion/exclusion criteria may apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00127270

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United States, Alabama
Alabama Research Center
Birmingham, Alabama, United States, 35209
United States, Arizona
Quality of Life Medical & Research
Tucson, Arizona, United States, 85712
United States, California
UCLA - Urology Sciences Research Foundation
Culver City, California, United States, 90232
San Diego Center for Urology Care
La Mesa, California, United States, 91942
Orange County Urology Associates
Laguna Woods, California, United States, 92653
Atlantic Urology Medical Group
Long Beach, California, United States, 90806
California Professional Research
Newport Beach, California, United States, 92660
Private Practice
North Hollywood, California, United States, 91607
Medical Center for Clinical Research
San Diego, California, United States, 92108
Encompass Clinical Research
Spring Valley, California, United States, 91978
Western Clinical Research
Torrance, California, United States, 90505
United States, Colorado
Urology Research Options
Aurora, Colorado, United States, 80012
Western Urologic Associates
Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
Connecticut Clinical Research Center
Waterbury, Connecticut, United States, 06708
United States, Florida
South Florida Medical Research
Aventura, Florida, United States, 33180
Advance Research Institute
New Port Richey, Florida, United States, 34652
Florida Healthcare Research
Ocala, Florida, United States, 34474
Winter Park Urology Associates
Orlando, Florida, United States, 32803
United States, Georgia
Atlanta Medical Research Institute
Alpharetta, Georgia, United States, 30005
Shepard Center
Atlanta, Georgia, United States, 30309
United States, Illinois
Deerpath Physicians Group
Gurnee, Illinois, United States, 60031
RMD Clinical Research Institute
Melrose Park, Illinois, United States, 60160
Southern Illinois Clinical Research Center
O'Fallon, Illinois, United States, 62269
Springfield Clinic
Springfield, Illinois, United States, 62701
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Welborn Clinic
Evansville, Indiana, United States, 47714
Urology of Indiana
Indianapolis, Indiana, United States, 46254
Metropolitan Urology
Jeffersonville, Indiana, United States, 47130
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Urologic Surgery Associates
Overland Park, Kansas, United States, 66215
Pratt Internal Medicine Group
Pratt, Kansas, United States, 67124
Cotton-O'Neil Clinic
Topeka, Kansas, United States, 66606
Hearthland Research Associates
Wichita, Kansas, United States, 67207
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Adult and Pediatric Urology
St. Cloud, Minnesota, United States, 56303
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Mississippi Urology Clinical Research
Jackson, Mississippi, United States, 39202
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PPS Clinical Research
St. Louis, Missouri, United States, 63141
Washing Univ School of Medicine - Urologic Research Center
St. Louis, Missouri, United States, 63141
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Women's Clinic of Lincoln
Lincoln, Nebraska, United States, 68510
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Omaha, Nebraska, United States, 68131
Meridian Clinical Research
Omaha, Nebraska, United States, 68134
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Lawrenceville Urology
Lawrenceville, New Jersey, United States, 08648
Center for Urologic Care
Voorhees, New Jersey, United States, 08043
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Jacobi Medical Center
Bronx, New York, United States, 10461
Central New York Clinical Research
Manlius, New York, United States, 13104
Hudson Valley Urology
Poughkeepsie, New York, United States, 12601
United States, North Carolina
Northeast Urology Research
Concord, North Carolina, United States, 28025
Multi Specialty Research Associates of NC
Raleigh, North Carolina, United States, 27609
Piedmont Medical Research Associates
Winston Salem, North Carolina, United States, 27103
United States, Oklahoma
Private Practice
Edmond, Oklahoma, United States, 73034
United States, Oregon
Southern Oregon Health and Wellness
Medford, Oregon, United States, 97504
Portland Clinic
Portland, Oregon, United States, 97205
Williamette Women's Health
Tualatin, Oregon, United States, 97232
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Research Protocol Management Specialists
Pittsburgh, Pennsylvania, United States, 15243
Univ. of Pittsburgh Medical Center- Dept of Urology
Pittsburg, Pennsylvania, United States, 15213
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Columbia, South Carolina, United States, 29201
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Doctors for Women
Nashville, Tennessee, United States, 37203
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Corsicana, Texas, United States, 75110
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Dallas, Texas, United States, 75231
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Dallas, Texas, United States, 75231
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Houston, Texas, United States, 77030
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Houston, Texas, United States, 77054
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Lake Jackson, Texas, United States, 77566
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Centerville, Utah, United States, 84014
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Salt Lake City, Utah, United States, 84102
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Salt Lake City, Utah, United States, 84124
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Virginia Urology
Richmond, Virginia, United States, 23235
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Virginia Beach, Virginia, United States, 23454
United States, Washington
Radiant Research
Lakewood, Washington, United States, 98499
Valley Women's Clinic
Renton, Washington, United States, 98055
Sponsors and Collaborators
Procter and Gamble
Study Director: Novartis Pharmaceuticals Corp. Novartis Pharmaceutical

Responsible Party: External Affairs, Novartis Identifier: NCT00127270     History of Changes
Other Study ID Numbers: CDAR328AUS01
First Posted: August 5, 2005    Key Record Dates
Last Update Posted: January 24, 2008
Last Verified: January 2008

Keywords provided by Novartis:
Overactive Bladder
Bladder hyperactivity
Urge Incontinence

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Bladder, Overactive
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Urinary Bladder Diseases
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents