CClinicalTrials.gg
CompletedNCT00127270Updated Jan 24, 2008

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

A Phase 4 interventional study of Darifenacin and Darifenacin in Urinary Incontinence, sponsored by Novartis. Completed at 67 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-01-24.

Sponsored by Novartis · Phase 4 and Interventional

Phase
Phase 4
Study type
Interventional
Enrollment
395
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Urinary Incontinence

Keywords

  • OAB
  • Overactive Bladder
  • Bladder hyperactivity
  • Urge Incontinence
  • Incontinence
  • Bladder
03

In context

Urinary Incontinence

1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.

This study's enrollment of 395 is above the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.

Browse Urinary Incontinence studies →

Lead sponsor

Novartis is the lead sponsor of 703 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All

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

Exclusion Criteria:

  • Post void residual > 100ml/sec
  • Urine flow rate (Qmax) \<10ml/sec for males only

Other protocol-defined inclusion/exclusion criteria may apply

05

Study design

Phase
Phase 4
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
395 participants (actual)

Study arms

  • Experimental
    1

    Darifenacin

    Drug: Darifenacin

  • Other
    2

    Darifenacin in combination with Behavioral Modification Programme for Symptoms of Overactive Bladder

    Drug: Darifenacin · Behavioral: Behavioral therapy

Interventions

  • DrugDarifenacin

    Darifenacin tablets 7,5 mg once daily with the possibility to up-titrate to 15 mg once daily

    Also known as: Enablex

  • DrugDarifenacin

    Darifenacin tablets 7,5 mg or 15 mg once daily

  • BehavioralBehavioral therapy

    Behavioral Modification Programme for symptoms of overactive bladder

06

What researchers measure

Primary outcomes

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

Secondary outcomes

  1. Change from baseline in average number of urination episodes per patient per day at Week 2, Week 6

  2. 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

  3. Quality of Life (baseline, Week 6, Week 12)

07

Study locations

67 sites
  • Alabama Research Center
    Birmingham, Alabama 35209, United States
  • Quality of Life Medical & Research
    Tucson, Arizona 85712, United States
  • UCLA - Urology Sciences Research Foundation
    Culver City, California 90232, United States
  • San Diego Center for Urology Care
    La Mesa, California 91942, United States
  • Orange County Urology Associates
    Laguna Woods, California 92653, United States
  • Atlantic Urology Medical Group
    Long Beach, California 90806, United States
  • California Professional Research
    Newport Beach, California 92660, United States
  • Private Practice
    North Hollywood, California 91607, United States
  • Medical Center for Clinical Research
    San Diego, California 92108, United States
  • Encompass Clinical Research
    Spring Valley, California 91978, United States
  • Western Clinical Research
    Torrance, California 90505, United States
  • Urology Research Options
    Aurora, Colorado 80012, United States
  • Western Urologic Associates
    Wheat Ridge, Colorado 80033, United States
  • Connecticut Clinical Research Center
    Waterbury, Connecticut 06708, United States
  • South Florida Medical Research
    Aventura, Florida 33180, United States
  • Advance Research Institute
    New Port Richey, Florida 34652, United States
  • Florida Healthcare Research
    Ocala, Florida 34474, United States
  • Winter Park Urology Associates
    Orlando, Florida 32803, United States
  • Atlanta Medical Research Institute
    Alpharetta, Georgia 30005, United States
  • Shepard Center
    Atlanta, Georgia 30309, United States
  • Deerpath Physicians Group
    Gurnee, Illinois 60031, 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
  • Welborn Clinic
    Evansville, Indiana 47714, United States
  • Urology of Indiana
    Indianapolis, Indiana 46254, United States
  • Metropolitan Urology
    Jeffersonville, Indiana 47130, United States
  • Urologic Surgery Associates
    Overland Park, Kansas 66215, United States
  • Pratt Internal Medicine Group
    Pratt, Kansas 67124, United States
  • Cotton-O'Neil Clinic
    Topeka, Kansas 66606, United States
  • Hearthland Research Associates
    Wichita, Kansas 67207, United States
  • Adult and Pediatric Urology
    St. Cloud, Minnesota 56303, United States
  • Mississippi Urology Clinical Research
    Jackson, Mississippi 39202, United States
  • PPS Clinical Research
    St. Louis, Missouri 63141, United States
  • Washing Univ School of Medicine - Urologic Research Center
    St. Louis, Missouri 63141, United States
  • Women's Clinic of Lincoln
    Lincoln, Nebraska 68510, United States
  • Quality Clinical Research
    Omaha, Nebraska 68131, United States
  • Meridian Clinical Research
    Omaha, Nebraska 68134, United States
  • Lawrenceville Urology
    Lawrenceville, New Jersey 08648, United States
  • Center for Urologic Care
    Voorhees, New Jersey 08043, United States
  • Jacobi Medical Center
    Bronx, New York 10461, United States
  • Central New York Clinical Research
    Manlius, New York 13104, United States
  • Hudson Valley Urology
    Poughkeepsie, New York 12601, United States
  • Northeast Urology Research
    Concord, North Carolina 28025, 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
  • Private Practice
    Edmond, Oklahoma 73034, United States
  • Southern Oregon Health and Wellness
    Medford, Oregon 97504, United States
  • Portland Clinic
    Portland, Oregon 97205, United States
  • Williamette Women's Health
    Tualatin, Oregon 97232, United States
  • Research Protocol Management Specialists
    Pittsburgh, Pennsylvania 15243, United States
  • Univ. of Pittsburgh Medical Center- Dept of Urology
    Pittsburg, Pennsylvania 15213, 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
  • Radiant Research
    Dallas, Texas 75231, United States
  • Urology Clinics of North Texas
    Dallas, Texas 75231, United States
  • Advances in Health
    Houston, Texas 77030, United States
  • Kelsey Seybold Research Foundation
    Houston, Texas 77054, United States
  • R/D Clinical Research
    Lake Jackson, Texas 77566, United States
  • Progressive Clinical Research
    Centerville, Utah 84014, United States
  • Intermountain Clinical Research
    Salt Lake City, Utah 84102, United States
  • Salt Lake Research
    Salt Lake City, Utah 84124, United States
  • Virginia Urology
    Richmond, Virginia 23235, United States
  • East Coast Clinical Research
    Virginia Beach, Virginia 23454, United States
  • Radiant Research
    Lakewood, Washington 98499, United States
  • Valley Women's Clinic
    Renton, Washington 98055, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 24, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00127270
Lead sponsor
Novartis
Collaborators
Procter and Gamble
First posted
Aug 5, 2005
Start date
May 2005
Completion
Feb 2006
Last update
Jan 24, 2008

Study contacts

Novartis Pharmaceuticals Corp.
study director · Novartis Pharmaceutical
View the source record on ClinicalTrials.gov ↗

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