Using Behavioral Therapy in Combination With Darifenacin for Symptoms of Overactive Bladder
1 other identifier
interventional
395
1 country
67
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2005
Shorter than P25 for phase_4
67 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
June 30, 2005
CompletedFirst Posted
Study publicly available on registry
August 5, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2006
CompletedJanuary 24, 2008
January 1, 2008
June 30, 2005
January 23, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Study Arms (2)
1
EXPERIMENTALDarifenacin
2
OTHERDarifenacin in combination with Behavioral Modification Programme for Symptoms of Overactive Bladder
Interventions
Darifenacin tablets 7,5 mg once daily with the possibility to up-titrate to 15 mg once daily
Eligibility Criteria
You may qualify if:
- Symptoms of overactive bladder
- Capable of independent toileting and completing a micturition diary
- Able to comprehend English and follow study procedures and instructions
You may not qualify if:
- Post void residual \> 100ml/sec
- Urine flow rate (Qmax) \<10ml/sec for males only
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
- Procter and Gamblecollaborator
Study Sites (67)
Alabama Research Center
Birmingham, Alabama, 35209, United States
Quality of Life Medical & Research
Tucson, Arizona, 85712, United States
UCLA - Urology Sciences Research Foundation
Culver City, California, 90232, United States
San Diego Center for Urology Care
La Mesa, California, 91942, United States
Orange County Urology Associates
Laguna Woods, California, 92653, United States
Atlantic Urology Medical Group
Long Beach, California, 90806, United States
California Professional Research
Newport Beach, California, 92660, United States
Private Practice
North Hollywood, California, 91607, United States
Medical Center for Clinical Research
San Diego, California, 92108, United States
Encompass Clinical Research
Spring Valley, California, 91978, United States
Western Clinical Research
Torrance, California, 90505, United States
Urology Research Options
Aurora, Colorado, 80012, United States
Western Urologic Associates
Wheat Ridge, Colorado, 80033, United States
Connecticut Clinical Research Center
Waterbury, Connecticut, 06708, United States
South Florida Medical Research
Aventura, Florida, 33180, United States
Advance Research Institute
New Port Richey, Florida, 34652, United States
Florida Healthcare Research
Ocala, Florida, 34474, United States
Winter Park Urology Associates
Orlando, Florida, 32803, United States
Atlanta Medical Research Institute
Alpharetta, Georgia, 30005, United States
Shepard Center
Atlanta, Georgia, 30309, United States
Deerpath Physicians Group
Gurnee, Illinois, 60031, United States
RMD Clinical Research Institute
Melrose Park, Illinois, 60160, United States
Southern Illinois Clinical Research Center
O'Fallon, Illinois, 62269, United States
Springfield Clinic
Springfield, Illinois, 62701, United States
Welborn Clinic
Evansville, Indiana, 47714, United States
Urology of Indiana
Indianapolis, Indiana, 46254, United States
Metropolitan Urology
Jeffersonville, Indiana, 47130, United States
Urologic Surgery Associates
Overland Park, Kansas, 66215, United States
Pratt Internal Medicine Group
Pratt, Kansas, 67124, United States
Cotton-O'Neil Clinic
Topeka, Kansas, 66606, United States
Hearthland Research Associates
Wichita, Kansas, 67207, United States
Adult and Pediatric Urology
Saint Cloud, Minnesota, 56303, United States
Mississippi Urology Clinical Research
Jackson, Mississippi, 39202, United States
PPS Clinical Research
St Louis, Missouri, 63141, United States
Washing Univ School of Medicine - Urologic Research Center
St Louis, Missouri, 63141, United States
Women's Clinic of Lincoln
Lincoln, Nebraska, 68510, United States
Quality Clinical Research
Omaha, Nebraska, 68131, United States
Meridian Clinical Research
Omaha, Nebraska, 68134, United States
Lawrenceville Urology
Lawrenceville, New Jersey, 08648, United States
Center for Urologic Care
Voorhees Township, New Jersey, 08043, United States
Central New York Clinical Research
Manlius, New York, 13104, United States
Hudson Valley Urology
Poughkeepsie, New York, 12601, United States
Jacobi Medical Center
The Bronx, New York, 10461, United States
Northeast Urology Research
Concord, North Carolina, 28025, United States
Multi Specialty Research Associates of NC
Raleigh, North Carolina, 27609, United States
Piedmont Medical Research Associates
Winston-Salem, North Carolina, 27103, United States
Private Practice
Edmond, Oklahoma, 73034, United States
Southern Oregon Health and Wellness
Medford, Oregon, 97504, United States
Portland Clinic
Portland, Oregon, 97205, United States
Williamette Women's Health
Tualatin, Oregon, 97232, United States
Univ. of Pittsburgh Medical Center- Dept of Urology
Pittsburgh, Pennsylvania, 15213, United States
Research Protocol Management Specialists
Pittsburgh, Pennsylvania, 15243, United States
South Carolina Clinical Research Center
Columbia, South Carolina, 29201, United States
Doctors for Women
Nashville, Tennessee, 37203, United States
Medical Arts Clinic
Corsicana, Texas, 75110, United States
Radiant Research
Dallas, Texas, 75231, United States
Urology Clinics of North Texas
Dallas, Texas, 75231, United States
Advances in Health
Houston, Texas, 77030, United States
Kelsey Seybold Research Foundation
Houston, Texas, 77054, United States
R/D Clinical Research
Lake Jackson, Texas, 77566, United States
Progressive Clinical Research
Centerville, Utah, 84014, United States
Intermountain Clinical Research
Salt Lake City, Utah, 84102, United States
Salt Lake Research
Salt Lake City, Utah, 84124, United States
Virginia Urology
Richmond, Virginia, 23235, United States
East Coast Clinical Research
Virginia Beach, Virginia, 23454, United States
Radiant Research
Lakewood, Washington, 98499, United States
Valley Women's Clinic
Renton, Washington, 98055, United States
Related Publications (1)
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.
PMID: 37811598DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals Corp.
Novartis Pharmaceutical
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 30, 2005
First Posted
August 5, 2005
Study Start
May 1, 2005
Study Completion
February 1, 2006
Last Updated
January 24, 2008
Record last verified: 2008-01