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

NCT ID: NCT00127270

Last Updated: 2008-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

395 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2006-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Urinary Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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1

Darifenacin

Group Type EXPERIMENTAL

Darifenacin

Intervention Type DRUG

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

2

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

Group Type OTHER

Darifenacin

Intervention Type DRUG

Darifenacin tablets 7,5 mg or 15 mg once daily

Behavioral therapy

Intervention Type BEHAVIORAL

Behavioral Modification Programme for symptoms of overactive bladder

Interventions

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Darifenacin

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

Intervention Type DRUG

Darifenacin

Darifenacin tablets 7,5 mg or 15 mg once daily

Intervention Type DRUG

Behavioral therapy

Behavioral Modification Programme for symptoms of overactive bladder

Intervention Type BEHAVIORAL

Other Intervention Names

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Enablex

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Procter and Gamble

INDUSTRY

Sponsor Role collaborator

Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Novartis

Principal Investigators

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Novartis Pharmaceuticals Corp.

Role: STUDY_DIRECTOR

Novartis Pharmaceutical

Locations

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Alabama Research Center

Birmingham, Alabama, United States

Site Status

Quality of Life Medical & Research

Tucson, Arizona, United States

Site Status

UCLA - Urology Sciences Research Foundation

Culver City, California, United States

Site Status

San Diego Center for Urology Care

La Mesa, California, United States

Site Status

Orange County Urology Associates

Laguna Woods, California, United States

Site Status

Atlantic Urology Medical Group

Long Beach, California, United States

Site Status

California Professional Research

Newport Beach, California, United States

Site Status

Private Practice

North Hollywood, California, United States

Site Status

Medical Center for Clinical Research

San Diego, California, United States

Site Status

Encompass Clinical Research

Spring Valley, California, United States

Site Status

Western Clinical Research

Torrance, California, United States

Site Status

Urology Research Options

Aurora, Colorado, United States

Site Status

Western Urologic Associates

Wheat Ridge, Colorado, United States

Site Status

Connecticut Clinical Research Center

Waterbury, Connecticut, United States

Site Status

South Florida Medical Research

Aventura, Florida, United States

Site Status

Advance Research Institute

New Port Richey, Florida, United States

Site Status

Florida Healthcare Research

Ocala, Florida, United States

Site Status

Winter Park Urology Associates

Orlando, Florida, United States

Site Status

Atlanta Medical Research Institute

Alpharetta, Georgia, United States

Site Status

Shepard Center

Atlanta, Georgia, United States

Site Status

Deerpath Physicians Group

Gurnee, Illinois, United States

Site Status

RMD Clinical Research Institute

Melrose Park, Illinois, United States

Site Status

Southern Illinois Clinical Research Center

O'Fallon, Illinois, United States

Site Status

Springfield Clinic

Springfield, Illinois, United States

Site Status

Welborn Clinic

Evansville, Indiana, United States

Site Status

Urology of Indiana

Indianapolis, Indiana, United States

Site Status

Metropolitan Urology

Jeffersonville, Indiana, United States

Site Status

Urologic Surgery Associates

Overland Park, Kansas, United States

Site Status

Pratt Internal Medicine Group

Pratt, Kansas, United States

Site Status

Cotton-O'Neil Clinic

Topeka, Kansas, United States

Site Status

Hearthland Research Associates

Wichita, Kansas, United States

Site Status

Adult and Pediatric Urology

Saint Cloud, Minnesota, United States

Site Status

Mississippi Urology Clinical Research

Jackson, Mississippi, United States

Site Status

PPS Clinical Research

St Louis, Missouri, United States

Site Status

Washing Univ School of Medicine - Urologic Research Center

St Louis, Missouri, United States

Site Status

Women's Clinic of Lincoln

Lincoln, Nebraska, United States

Site Status

Quality Clinical Research

Omaha, Nebraska, United States

Site Status

Meridian Clinical Research

Omaha, Nebraska, United States

Site Status

Lawrenceville Urology

Lawrenceville, New Jersey, United States

Site Status

Center for Urologic Care

Voorhees Township, New Jersey, United States

Site Status

Central New York Clinical Research

Manlius, New York, United States

Site Status

Hudson Valley Urology

Poughkeepsie, New York, United States

Site Status

Jacobi Medical Center

The Bronx, New York, United States

Site Status

Northeast Urology Research

Concord, North Carolina, United States

Site Status

Multi Specialty Research Associates of NC

Raleigh, North Carolina, United States

Site Status

Piedmont Medical Research Associates

Winston-Salem, North Carolina, United States

Site Status

Private Practice

Edmond, Oklahoma, United States

Site Status

Southern Oregon Health and Wellness

Medford, Oregon, United States

Site Status

Portland Clinic

Portland, Oregon, United States

Site Status

Williamette Women's Health

Tualatin, Oregon, United States

Site Status

Univ. of Pittsburgh Medical Center- Dept of Urology

Pittsburgh, Pennsylvania, United States

Site Status

Research Protocol Management Specialists

Pittsburgh, Pennsylvania, United States

Site Status

South Carolina Clinical Research Center

Columbia, South Carolina, United States

Site Status

Doctors for Women

Nashville, Tennessee, United States

Site Status

Medical Arts Clinic

Corsicana, Texas, United States

Site Status

Radiant Research

Dallas, Texas, United States

Site Status

Urology Clinics of North Texas

Dallas, Texas, United States

Site Status

Advances in Health

Houston, Texas, United States

Site Status

Kelsey Seybold Research Foundation

Houston, Texas, United States

Site Status

R/D Clinical Research

Lake Jackson, Texas, United States

Site Status

Progressive Clinical Research

Centerville, Utah, United States

Site Status

Intermountain Clinical Research

Salt Lake City, Utah, United States

Site Status

Salt Lake Research

Salt Lake City, Utah, United States

Site Status

Virginia Urology

Richmond, Virginia, United States

Site Status

East Coast Clinical Research

Virginia Beach, Virginia, United States

Site Status

Radiant Research

Lakewood, Washington, United States

Site Status

Valley Women's Clinic

Renton, Washington, United States

Site Status

Countries

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United States

References

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Funada S, Yoshioka T, Luo Y, Sato A, Akamatsu S, Watanabe N. Bladder training for treating overactive bladder in adults. Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD013571. doi: 10.1002/14651858.CD013571.pub2.

Reference Type DERIVED
PMID: 37811598 (View on PubMed)

Other Identifiers

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CDAR328AUS01

Identifier Type: -

Identifier Source: org_study_id

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