Using Behavioral Therapy in Combination With Darifenacin for Symptoms of Overactive Bladder - Full Text View

Purpose

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.

Condition	Intervention	Phase
Urinary Incontinence	Drug: Darifenacin Behavioral: Behavioral therapy	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label
Official Title:	Using Behavioral Therapy in Combination With Drug-Darifenacin for Symptoms of Overactive Bladder

Resource links provided by NLM:

MedlinePlus related topics: Overactive Bladder Urinary Incontinence Urine and Urination

Drug Information available for: Darifenacin Darifenacin hydrobromide

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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)

Enrollment:	395
Study Start Date:	May 2005
Study Completion Date:	February 2006

Arms	Assigned Interventions
Experimental: 1 Darifenacin	Drug: Darifenacin Darifenacin tablets 7,5 mg once daily with the possibility to up-titrate to 15 mg once daily Other Name: Enablex
2 Darifenacin in combination with Behavioral Modification Programme for Symptoms of Overactive Bladder	Drug: Darifenacin Darifenacin tablets 7,5 mg or 15 mg once daily Behavioral: Behavioral therapy Behavioral Modification Programme for symptoms of overactive bladder

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00127270

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Locations

United States, Alabama
Alabama Research Center
Birmingham, Alabama, United States, 35209
United States, Arizona
Quality of Life Medical & Research
Tucson, Arizona, United States, 85712
United States, California
UCLA - Urology Sciences Research Foundation
Culver City, California, United States, 90232
San Diego Center for Urology Care
La Mesa, California, United States, 91942
Orange County Urology Associates
Laguna Woods, California, United States, 92653
Atlantic Urology Medical Group
Long Beach, California, United States, 90806
California Professional Research
Newport Beach, California, United States, 92660
Private Practice
North Hollywood, California, United States, 91607
Medical Center for Clinical Research
San Diego, California, United States, 92108
Encompass Clinical Research
Spring Valley, California, United States, 91978
Western Clinical Research
Torrance, California, United States, 90505
United States, Colorado
Urology Research Options
Aurora, Colorado, United States, 80012
Western Urologic Associates
Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
Connecticut Clinical Research Center
Waterbury, Connecticut, United States, 06708
United States, Florida
South Florida Medical Research
Aventura, Florida, United States, 33180
Advance Research Institute
New Port Richey, Florida, United States, 34652
Florida Healthcare Research
Ocala, Florida, United States, 34474
Winter Park Urology Associates
Orlando, Florida, United States, 32803
United States, Georgia
Atlanta Medical Research Institute
Alpharetta, Georgia, United States, 30005
Shepard Center
Atlanta, Georgia, United States, 30309
United States, Illinois
Deerpath Physicians Group
Gurnee, Illinois, United States, 60031
RMD Clinical Research Institute
Melrose Park, Illinois, United States, 60160
Southern Illinois Clinical Research Center
O'Fallon, Illinois, United States, 62269
Springfield Clinic
Springfield, Illinois, United States, 62701
United States, Indiana
Welborn Clinic
Evansville, Indiana, United States, 47714
Urology of Indiana
Indianapolis, Indiana, United States, 46254
Metropolitan Urology
Jeffersonville, Indiana, United States, 47130
United States, Kansas
Urologic Surgery Associates
Overland Park, Kansas, United States, 66215
Pratt Internal Medicine Group
Pratt, Kansas, United States, 67124
Cotton-O'Neil Clinic
Topeka, Kansas, United States, 66606
Hearthland Research Associates
Wichita, Kansas, United States, 67207
United States, Minnesota
Adult and Pediatric Urology
St. Cloud, Minnesota, United States, 56303
United States, Mississippi
Mississippi Urology Clinical Research
Jackson, Mississippi, United States, 39202
United States, Missouri
Washing Univ School of Medicine - Urologic Research Center
St. Louis, Missouri, United States, 63141
PPS Clinical Research
St. Louis, Missouri, United States, 63141
United States, Nebraska
Women's Clinic of Lincoln
Lincoln, Nebraska, United States, 68510
Meridian Clinical Research
Omaha, Nebraska, United States, 68134
Quality Clinical Research
Omaha, Nebraska, United States, 68131
United States, New Jersey
Lawrenceville Urology
Lawrenceville, New Jersey, United States, 08648
Center for Urologic Care
Voorhees, New Jersey, United States, 08043
United States, New York
Jacobi Medical Center
Bronx, New York, United States, 10461
Central New York Clinical Research
Manlius, New York, United States, 13104
Hudson Valley Urology
Poughkeepsie, New York, United States, 12601
United States, North Carolina
Northeast Urology Research
Concord, North Carolina, United States, 28025
Multi Specialty Research Associates of NC
Raleigh, North Carolina, United States, 27609
Piedmont Medical Research Associates
Winston Salem, North Carolina, United States, 27103
United States, Oklahoma
Private Practice
Edmond, Oklahoma, United States, 73034
United States, Oregon
Southern Oregon Health and Wellness
Medford, Oregon, United States, 97504
Portland Clinic
Portland, Oregon, United States, 97205
Williamette Women's Health
Tualatin, Oregon, United States, 97232
United States, Pennsylvania
Univ. of Pittsburgh Medical Center- Dept of Urology
Pittsburg, Pennsylvania, United States, 15213
Research Protocol Management Specialists
Pittsburgh, Pennsylvania, United States, 15243
United States, South Carolina
South Carolina Clinical Research Center
Columbia, South Carolina, United States, 29201
United States, Tennessee
Doctors for Women
Nashville, Tennessee, United States, 37203
United States, Texas
Medical Arts Clinic
Corsicana, Texas, United States, 75110
Radiant Research
Dallas, Texas, United States, 75231
Urology Clinics of North Texas
Dallas, Texas, United States, 75231
Kelsey Seybold Research Foundation
Houston, Texas, United States, 77054
Advances in Health
Houston, Texas, United States, 77030
R/D Clinical Research
Lake Jackson, Texas, United States, 77566
United States, Utah
Progressive Clinical Research
Centerville, Utah, United States, 84014
Salt Lake Research
Salt Lake City, Utah, United States, 84124
Intermountain Clinical Research
Salt Lake City, Utah, United States, 84102
United States, Virginia
Virginia Urology
Richmond, Virginia, United States, 23235
East Coast Clinical Research
Virginia Beach, Virginia, United States, 23454
United States, Washington
Radiant Research
Lakewood, Washington, United States, 98499
Valley Women's Clinic
Renton, Washington, United States, 98055

Sponsors and Collaborators

Novartis

Procter and Gamble

Investigators

Study Director:

Novartis Pharmaceuticals Corp.

Novartis Pharmaceutical

More Information

No publications provided

Responsible Party:	External Affairs, Novartis
ClinicalTrials.gov Identifier:	NCT00127270 History of Changes
Other Study ID Numbers:	CDAR328AUS01
Study First Received:	June 30, 2005
Last Updated:	January 23, 2008
Health Authority:	United States: Institutional Review Board

Keywords provided by Novartis:

OAB
Overactive Bladder
Bladder hyperactivity

Urge Incontinence
Incontinence
Bladder

Additional relevant MeSH terms:

Urinary Incontinence
Urinary Bladder, Overactive
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Urinary Bladder Diseases
Darifenacin

Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013