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

January 23, 2008 updated by: Novartis

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

395

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Darifenacin
Drug: Darifenacin
Darifenacin tablets 7,5 mg once daily with the possibility to up-titrate to 15 mg once daily
Other Names:
  • Enablex
Drug: Darifenacin
Darifenacin tablets 7,5 mg or 15 mg once daily
OTHER: 2
Darifenacin in combination with Behavioral Modification Programme for Symptoms of Overactive Bladder
Drug: Darifenacin
Darifenacin tablets 7,5 mg once daily with the possibility to up-titrate to 15 mg once daily
Other Names:
  • Enablex
Drug: Darifenacin
Darifenacin tablets 7,5 mg or 15 mg once daily
Behavioral: Behavioral therapy
Behavioral Modification Programme for symptoms of overactive bladder

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Collaborators

Procter and Gamble

Investigators

  • Study Director: Novartis Pharmaceuticals Corp., Novartis Pharmaceutical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Study Completion (ACTUAL)

February 1, 2006

Study Registration Dates

First Submitted

June 30, 2005

First Submitted That Met QC Criteria

August 4, 2005

First Posted (ESTIMATE)

August 5, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

January 24, 2008

Last Update Submitted That Met QC Criteria

January 23, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDAR328AUS01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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