Urinary Incontinence Clinical Trial
Official title:
Using Behavioral Therapy in Combination With Drug-Darifenacin for Symptoms of Overactive Bladder
| Verified date | January 2008 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 395 |
| Est. completion date | February 2006 |
| Est. primary completion date | |
| Accepts healthy volunteers | |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
| Country | Name | City | State |
|---|---|---|---|
| United States | Atlanta Medical Research Institute | Alpharetta | Georgia |
| United States | Shepard Center | Atlanta | Georgia |
| United States | Urology Research Options | Aurora | Colorado |
| United States | South Florida Medical Research | Aventura | Florida |
| United States | Alabama Research Center | Birmingham | Alabama |
| United States | Jacobi Medical Center | Bronx | New York |
| United States | Progressive Clinical Research | Centerville | Utah |
| United States | South Carolina Clinical Research Center | Columbia | South Carolina |
| United States | Northeast Urology Research | Concord | North Carolina |
| United States | Medical Arts Clinic | Corsicana | Texas |
| United States | UCLA - Urology Sciences Research Foundation | Culver City | California |
| United States | Radiant Research | Dallas | Texas |
| United States | Urology Clinics of North Texas | Dallas | Texas |
| United States | Private Practice | Edmond | Oklahoma |
| United States | Welborn Clinic | Evansville | Indiana |
| United States | Deerpath Physicians Group | Gurnee | Illinois |
| United States | Advances in Health | Houston | Texas |
| United States | Kelsey Seybold Research Foundation | Houston | Texas |
| United States | Urology of Indiana | Indianapolis | Indiana |
| United States | Mississippi Urology Clinical Research | Jackson | Mississippi |
| United States | Metropolitan Urology | Jeffersonville | Indiana |
| United States | San Diego Center for Urology Care | La Mesa | California |
| United States | Orange County Urology Associates | Laguna Woods | California |
| United States | R/D Clinical Research | Lake Jackson | Texas |
| United States | Radiant Research | Lakewood | Washington |
| United States | Lawrenceville Urology | Lawrenceville | New Jersey |
| United States | Women's Clinic of Lincoln | Lincoln | Nebraska |
| United States | Atlantic Urology Medical Group | Long Beach | California |
| United States | Central New York Clinical Research | Manlius | New York |
| United States | Southern Oregon Health and Wellness | Medford | Oregon |
| United States | RMD Clinical Research Institute | Melrose Park | Illinois |
| United States | Doctors for Women | Nashville | Tennessee |
| United States | Advance Research Institute | New Port Richey | Florida |
| United States | California Professional Research | Newport Beach | California |
| United States | Private Practice | North Hollywood | California |
| United States | Southern Illinois Clinical Research Center | O'Fallon | Illinois |
| United States | Florida Healthcare Research | Ocala | Florida |
| United States | Meridian Clinical Research | Omaha | Nebraska |
| United States | Quality Clinical Research | Omaha | Nebraska |
| United States | Winter Park Urology Associates | Orlando | Florida |
| United States | Urologic Surgery Associates | Overland Park | Kansas |
| United States | Univ. of Pittsburgh Medical Center- Dept of Urology | Pittsburg | Pennsylvania |
| United States | Research Protocol Management Specialists | Pittsburgh | Pennsylvania |
| United States | Portland Clinic | Portland | Oregon |
| United States | Hudson Valley Urology | Poughkeepsie | New York |
| United States | Pratt Internal Medicine Group | Pratt | Kansas |
| United States | Multi Specialty Research Associates of NC | Raleigh | North Carolina |
| United States | Valley Women's Clinic | Renton | Washington |
| United States | Virginia Urology | Richmond | Virginia |
| United States | Intermountain Clinical Research | Salt Lake City | Utah |
| United States | Salt Lake Research | Salt Lake City | Utah |
| United States | Medical Center for Clinical Research | San Diego | California |
| United States | Encompass Clinical Research | Spring Valley | California |
| United States | Springfield Clinic | Springfield | Illinois |
| United States | Adult and Pediatric Urology | St. Cloud | Minnesota |
| United States | PPS Clinical Research | St. Louis | Missouri |
| United States | Washing Univ School of Medicine - Urologic Research Center | St. Louis | Missouri |
| United States | Cotton-O'Neil Clinic | Topeka | Kansas |
| United States | Western Clinical Research | Torrance | California |
| United States | Williamette Women's Health | Tualatin | Oregon |
| United States | Quality of Life Medical & Research | Tucson | Arizona |
| United States | East Coast Clinical Research | Virginia Beach | Virginia |
| United States | Center for Urologic Care | Voorhees | New Jersey |
| United States | Connecticut Clinical Research Center | Waterbury | Connecticut |
| United States | Western Urologic Associates | Wheat Ridge | Colorado |
| United States | Hearthland Research Associates | Wichita | Kansas |
| United States | Piedmont Medical Research Associates | Winston Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis | Procter and Gamble |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from baseline in average number of urinations per patient per day at Week 12 | |||
| Secondary | Change from baseline in average number of urination episodes per patient per day at Week 2, Week 6 | |||
| Secondary | 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 | |||
| Secondary | Quality of Life (baseline, Week 6, Week 12) |
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