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

Condition(s) targeted: Urinary Incontinence

Intervention: Darifenacin (Drug); Darifenacin (Drug); Behavioral therapy (Behavioral)

Phase: Phase 4

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals Corp., Study Director, Affiliation: Novartis Pharmaceutical

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.

Official title: Using Behavioral Therapy in Combination With Drug-Darifenacin for Symptoms of Overactive Bladder

Study design: Other, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: Change from baseline in average number of urinations per patient per day at Week 12

Secondary outcome:

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)

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Alabama Research Center, Birmingham, Alabama 35209, United States

Quality of Life Medical & Research, Tucson, Arizona 85712, United States

San Diego Center for Urology Care, La Mesa, California 91942, United States

Encompass Clinical Research, Spring Valley, California 91978, United States

California Professional Research, Newport Beach, California 92660, United States

UCLA - Urology Sciences Research Foundation, Culver City, California 90232, United States

Atlantic Urology Medical Group, Long Beach, California 90806, United States

Western Clinical Research, Torrance, California 90505, United States

Medical Center for Clinical Research, San Diego, California 92108, United States

Private Practice, North Hollywood, California 91607, United States

Orange County Urology Associates, Laguna Woods, California 92653, United States

Western Urologic Associates, Wheat Ridge, Colorado 80033, United States

Urology Research Options, Aurora, Colorado 80012, United States

Connecticut Clinical Research Center, Waterbury, Connecticut 06708, United States

Advance Research Institute, New Port Richey, Florida 34652, United States

Winter Park Urology Associates, Orlando, Florida 32803, United States

South Florida Medical Research, Aventura, Florida 33180, United States

Florida Healthcare Research, Ocala, Florida 34474, United States

Atlanta Medical Research Institute, Alpharetta, Georgia 30005, United States

Shepard Center, Atlanta, Georgia 30309, 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

Deerpath Physicians Group, Gurnee, Illinois 60031, United States

Urology of Indiana, Indianapolis, Indiana 46254, United States

Metropolitan Urology, Jeffersonville, Indiana 47130, United States

Welborn Clinic, Evansville, Indiana 47714, United States

Hearthland Research Associates, Wichita, Kansas 67207, United States

Cotton-O'Neil Clinic, Topeka, Kansas 66606, United States

Pratt Internal Medicine Group, Pratt, Kansas 67124, United States

Urologic Surgery Associates, Overland Park, Kansas 66215, United States

Adult and Pediatric Urology, St. Cloud, Minnesota 56303, United States

Mississippi Urology Clinical Research, Jackson, Mississippi 39202, United States

Washing Univ School of Medicine - Urologic Research Center, St. Louis, Missouri 63141, United States

PPS Clinical Research, St. Louis, Missouri 63141, United States

Women's Clinic of Lincoln, Lincoln, Nebraska 68510, United States

Meridian Clinical Research, Omaha, Nebraska 68134, United States

Quality Clinical Research, Omaha, Nebraska 68131, United States

Lawrenceville Urology, Lawrenceville, New Jersey 08648, United States

Center for Urologic Care, Voorhees, New Jersey 08043, United States

Hudson Valley Urology, Poughkeepsie, New York 12601, United States

Central New York Clinical Research, Manlius, New York 13104, United States

Jacobi Medical Center, Bronx, New York 10461, 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

Northeast Urology Research, Concord, North Carolina 28025, United States

Private Practice, Edmond, Oklahoma 73034, United States

Portland Clinic, Portland, Oregon 97205, United States

Williamette Women's Health, Tualatin, Oregon 97232, United States

Southern Oregon Health and Wellness, Medford, Oregon 97504, United States

Univ. of Pittsburgh Medical Center- Dept of Urology, Pittsburg, 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

Kelsey Seybold Research Foundation, Houston, Texas 77054, United States

Urology Clinics of North Texas, Dallas, Texas 75231, United States

Radiant Research, Dallas, Texas 75231, United States

R/D Clinical Research, Lake Jackson, Texas 77566, United States

Advances in Health, Houston, Texas 77030, United States

Salt Lake Research, Salt Lake City, Utah 84124, United States

Progressive Clinical Research, Centerville, Utah 84014, United States

Intermountain Clinical Research, Salt Lake City, Utah 84102, United States

East Coast Clinical Research, Virginia Beach, Virginia 23454, United States

Virginia Urology, Richmond, Virginia 23235, United States

Radiant Research, Lakewood, Washington 98499, United States

Valley Women's Clinic, Renton, Washington 98055, United States

Starting date: May 2005
Ending date: February 2006
Last updated: January 23, 2008