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

Phase 4

Completed

• Conditions: Urinary Incontinence
• Interventions: Drug: Darifenacin; Behavioral: Behavioral therapy

• Registration Number: NCT00127270
• Lead Sponsor: Novartis

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2005-06-30
• Study First Submitted QC: 2005-08-04
• Study First Posted: 2005-08-05
• Study Completion: 2006-02
• Status Verified: 2008-01
• Last Update Submitted: 2008-01-23
• Last Update Posted: 2008-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 395

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Darifenacin	Darifenacin
2	Darifenacin	Darifenacin in combination with Behavioral Modification Programme for Symptoms of Overactive Bladder
2	Behavioral therapy	Darifenacin in combination with Behavioral Modification Programme for Symptoms of Overactive Bladder

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (65)

Alabama Research Center; 🇺🇸 Birmingham, Alabama, United States

Quality of Life Medical & Research; 🇺🇸 Tucson, Arizona, United States

UCLA - Urology Sciences Research Foundation; 🇺🇸 Culver City, California, United States

San Diego Center for Urology Care; 🇺🇸 La Mesa, California, United States

Orange County Urology Associates; 🇺🇸 Laguna Woods, California, United States

Atlantic Urology Medical Group; 🇺🇸 Long Beach, California, United States

California Professional Research; 🇺🇸 Newport Beach, California, United States

Private Practice; 🇺🇸 Edmond, Oklahoma, United States

Medical Center for Clinical Research; 🇺🇸 San Diego, California, United States

Encompass Clinical Research; 🇺🇸 Spring Valley, California, United States

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