Clinical trial NCT00127270: Using Behavioral Therapy in Combination With Darifenacin for Symptoms of Overactive Bladder
Official title: Using Behavioral Therapy in Combination With Drug-Darifenacin for Symptoms of Overactive Bladder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Urinary Incontinence
Keywords: OAB
Overactive Bladder
Bladder hyperactivity
Urge Incontinence
Incontinence
Bladder
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Procter and Gamble
First posted: 2005-08-05
Enrollment: 395
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in average number of urinations per patient per day at Week 12
Secondary outcomes:
measure: Change from baseline in average number of urination episodes per patient per day at Week 2, Week 6
measure: 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
measure: Quality of Life (baseline, Week 6, Week 12)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Research Center
state: Alabama
city: Tucson
country: United States
facility: Quality of Life Medical & Research
state: Arizona
city: Culver City
country: United States
facility: UCLA - Urology Sciences Research Foundation
state: California
city: La Mesa
country: United States
facility: San Diego Center for Urology Care
state: California
city: Laguna Woods
country: United States
facility: Orange County Urology Associates
state: California
city: Long Beach
country: United States
facility: Atlantic Urology Medical Group
state: California
city: Newport Beach
country: United States
facility: California Professional Research
state: California
city: North Hollywood
country: United States
facility: Private Practice
state: California
city: San Diego
country: United States
facility: Medical Center for Clinical Research
state: California
city: Spring Valley
country: United States
facility: Encompass Clinical Research
state: California
city: Torrance
country: United States
facility: Western Clinical Research
state: California
city: Aurora
country: United States
facility: Urology Research Options
state: Colorado
city: Wheat Ridge
country: United States
facility: Western Urologic Associates
state: Colorado
city: Waterbury
country: United States
facility: Connecticut Clinical Research Center
state: Connecticut
city: Aventura
country: United States
facility: South Florida Medical Research
state: Florida
city: New Port Richey
country: United States
facility: Advance Research Institute
state: Florida
city: Ocala
country: United States
facility: Florida Healthcare Research
state: Florida
city: Orlando
country: United States
facility: Winter Park Urology Associates
state: Florida
city: Alpharetta
country: United States
facility: Atlanta Medical Research Institute
state: Georgia
city: Atlanta
country: United States
facility: Shepard Center
state: Georgia
city: Gurnee
country: United States
facility: Deerpath Physicians Group
state: Illinois
city: Melrose Park
country: United States
facility: RMD Clinical Research Institute
state: Illinois
city: O'Fallon
country: United States
facility: Southern Illinois Clinical Research Center
state: Illinois
city: Springfield
country: United States
facility: Springfield Clinic
state: Illinois
city: Evansville
country: United States
facility: Welborn Clinic
state: Indiana
city: Indianapolis
country: United States
facility: Urology of Indiana
state: Indiana
city: Jeffersonville
country: United States
facility: Metropolitan Urology
state: Indiana
city: Overland Park
country: United States
facility: Urologic Surgery Associates
state: Kansas
city: Pratt
country: United States
facility: Pratt Internal Medicine Group
state: Kansas
city: Topeka
country: United States
facility: Cotton-O'Neil Clinic
state: Kansas
city: Wichita
country: United States
facility: Hearthland Research Associates
state: Kansas
city: St. Cloud
country: United States
facility: Adult and Pediatric Urology
state: Minnesota
city: Jackson
country: United States
facility: Mississippi Urology Clinical Research
state: Mississippi
city: St. Louis
country: United States
facility: PPS Clinical Research
state: Missouri
city: St. Louis
country: United States
facility: Washing Univ School of Medicine - Urologic Research Center
state: Missouri
city: Lincoln
country: United States
facility: Women's Clinic of Lincoln
state: Nebraska
city: Omaha
country: United States
facility: Quality Clinical Research
state: Nebraska
city: Omaha
country: United States
facility: Meridian Clinical Research
state: Nebraska
city: Lawrenceville
country: United States
facility: Lawrenceville Urology
state: New Jersey
city: Voorhees
country: United States
facility: Center for Urologic Care
state: New Jersey
city: Bronx
country: United States
facility: Jacobi Medical Center
state: New York
city: Manlius
country: United States
facility: Central New York Clinical Research
state: New York
city: Poughkeepsie
country: United States
facility: Hudson Valley Urology
state: New York
city: Concord
country: United States
facility: Northeast Urology Research
state: North Carolina
city: Raleigh
country: United States
facility: Multi Specialty Research Associates of NC
state: North Carolina
city: Winston Salem
country: United States
facility: Piedmont Medical Research Associates
state: North Carolina
city: Edmond
country: United States
facility: Private Practice
state: Oklahoma
city: Medford
country: United States
facility: Southern Oregon Health and Wellness
state: Oregon
city: Portland
country: United States
facility: Portland Clinic
state: Oregon
city: Tualatin
country: United States
facility: Williamette Women's Health
state: Oregon
city: Pittsburgh
country: United States
facility: Research Protocol Management Specialists
state: Pennsylvania
city: Pittsburg
country: United States
facility: Univ. of Pittsburgh Medical Center- Dept of Urology
state: Pennsylvania
city: Columbia
country: United States
facility: South Carolina Clinical Research Center
state: South Carolina
city: Nashville
country: United States
facility: Doctors for Women
state: Tennessee
city: Corsicana
country: United States
facility: Medical Arts Clinic
state: Texas
city: Dallas
country: United States
facility: Radiant Research
state: Texas
city: Dallas
country: United States
facility: Urology Clinics of North Texas
state: Texas
city: Houston
country: United States
facility: Advances in Health
state: Texas
city: Houston
country: United States
facility: Kelsey Seybold Research Foundation
state: Texas
city: Lake Jackson
country: United States
facility: R/D Clinical Research
state: Texas
city: Centerville
country: United States
facility: Progressive Clinical Research
state: Utah
city: Salt Lake City
country: United States
facility: Intermountain Clinical Research
state: Utah
city: Salt Lake City
country: United States
facility: Salt Lake Research
state: Utah
city: Richmond
country: United States
facility: Virginia Urology
state: Virginia
city: Virginia Beach
country: United States
facility: East Coast Clinical Research
state: Virginia
city: Lakewood
country: United States
facility: Radiant Research
state: Washington
city: Renton
country: United States
facility: Valley Women's Clinic
state: Washington
Study officials:
affiliation: Novartis Pharmaceutical
name: Novartis Pharmaceuticals Corp.
role: STUDY_DIRECTOR
References: