Using Behavioral Therapy in Combination With Darifenacin for Symptoms of Overactive Bladder
- Conditions
- Urinary Incontinence
- Interventions
- Behavioral: Behavioral therapy
- Registration Number
- NCT00127270
- Lead Sponsor
- Novartis
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 395
- Symptoms of overactive bladder
- Capable of independent toileting and completing a micturition diary
- Able to comprehend English and follow study procedures and instructions
- Post void residual > 100ml/sec
- Urine flow rate (Qmax) <10ml/sec for males only
Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Darifenacin Darifenacin 2 Darifenacin Darifenacin in combination with Behavioral Modification Programme for Symptoms of Overactive Bladder 2 Behavioral therapy Darifenacin in combination with Behavioral Modification Programme for Symptoms of Overactive Bladder
- Primary Outcome Measures
Name Time Method Change from baseline in average number of urinations per patient per day at Week 12
- Secondary Outcome Measures
Name Time Method 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)
Trial Locations
- Locations (65)
Research Protocol Management Specialists
🇺🇸Pittsburgh, Pennsylvania, United States
Southern Oregon Health and Wellness
🇺🇸Medford, Oregon, United States
Urologic Surgery Associates
🇺🇸Overland Park, Kansas, United States
Mississippi Urology Clinical Research
🇺🇸Jackson, Mississippi, United States
Advances in Health
🇺🇸Houston, Texas, United States
Kelsey Seybold Research Foundation
🇺🇸Houston, Texas, United States
California Professional Research
🇺🇸Newport Beach, California, United States
Washing Univ School of Medicine - Urologic Research Center
🇺🇸St. Louis, Missouri, United States
Atlanta Medical Research Institute
🇺🇸Alpharetta, Georgia, United States
Valley Women's Clinic
🇺🇸Renton, Washington, United States
Adult and Pediatric Urology
🇺🇸St. Cloud, Minnesota, United States
Cotton-O'Neil Clinic
🇺🇸Topeka, Kansas, United States
Pratt Internal Medicine Group
🇺🇸Pratt, Kansas, United States
Hearthland Research Associates
🇺🇸Wichita, Kansas, United States
Western Urologic Associates
🇺🇸Wheat Ridge, Colorado, United States
Atlantic Urology Medical Group
🇺🇸Long Beach, California, United States
PPS Clinical Research
🇺🇸St. Louis, Missouri, United States
Orange County Urology Associates
🇺🇸Laguna Woods, California, United States
Private Practice
🇺🇸Edmond, Oklahoma, United States
Western Clinical Research
🇺🇸Torrance, California, United States
Deerpath Physicians Group
🇺🇸Gurnee, Illinois, United States
UCLA - Urology Sciences Research Foundation
🇺🇸Culver City, California, United States
Shepard Center
🇺🇸Atlanta, Georgia, United States
Medical Center for Clinical Research
🇺🇸San Diego, California, United States
Welborn Clinic
🇺🇸Evansville, Indiana, United States
Metropolitan Urology
🇺🇸Jeffersonville, Indiana, United States
Springfield Clinic
🇺🇸Springfield, Illinois, United States
Southern Illinois Clinical Research Center
🇺🇸O'Fallon, Illinois, United States
Urology of Indiana
🇺🇸Indianapolis, Indiana, United States
Virginia Urology
🇺🇸Richmond, Virginia, United States
Center for Urologic Care
🇺🇸Voorhees, New Jersey, United States
Northeast Urology Research
🇺🇸Concord, North Carolina, United States
East Coast Clinical Research
🇺🇸Virginia Beach, Virginia, United States
Alabama Research Center
🇺🇸Birmingham, Alabama, United States
Urology Research Options
🇺🇸Aurora, Colorado, United States
Quality Clinical Research
🇺🇸Omaha, Nebraska, United States
Meridian Clinical Research
🇺🇸Omaha, Nebraska, United States
Univ. of Pittsburgh Medical Center- Dept of Urology
🇺🇸Pittsburg, Pennsylvania, United States
Doctors for Women
🇺🇸Nashville, Tennessee, United States
Intermountain Clinical Research
🇺🇸Salt Lake City, Utah, United States
Salt Lake Research
🇺🇸Salt Lake City, Utah, United States
South Florida Medical Research
🇺🇸Aventura, Florida, United States
Progressive Clinical Research
🇺🇸Centerville, Utah, United States
Quality of Life Medical & Research
🇺🇸Tucson, Arizona, United States
San Diego Center for Urology Care
🇺🇸La Mesa, California, United States
Encompass Clinical Research
🇺🇸Spring Valley, California, United States
RMD Clinical Research Institute
🇺🇸Melrose Park, Illinois, United States
Connecticut Clinical Research Center
🇺🇸Waterbury, Connecticut, United States
Hudson Valley Urology
🇺🇸Poughkeepsie, New York, United States
Central New York Clinical Research
🇺🇸Manlius, New York, United States
Multi Specialty Research Associates of NC
🇺🇸Raleigh, North Carolina, United States
Piedmont Medical Research Associates
🇺🇸Winston Salem, North Carolina, United States
Jacobi Medical Center
🇺🇸Bronx, New York, United States
Williamette Women's Health
🇺🇸Tualatin, Oregon, United States
South Carolina Clinical Research Center
🇺🇸Columbia, South Carolina, United States
Medical Arts Clinic
🇺🇸Corsicana, Texas, United States
Urology Clinics of North Texas
🇺🇸Dallas, Texas, United States
R/D Clinical Research
🇺🇸Lake Jackson, Texas, United States
Advance Research Institute
🇺🇸New Port Richey, Florida, United States
Portland Clinic
🇺🇸Portland, Oregon, United States
Lawrenceville Urology
🇺🇸Lawrenceville, New Jersey, United States
Women's Clinic of Lincoln
🇺🇸Lincoln, Nebraska, United States
Winter Park Urology Associates
🇺🇸Orlando, Florida, United States
Florida Healthcare Research
🇺🇸Ocala, Florida, United States
Radiant Research
🇺🇸Lakewood, Washington, United States