NCT00127270
Completed
Phase 4
Using Behavioral Therapy in Combination With Drug-Darifenacin for Symptoms of Overactive Bladder
Overview
- Phase
- Phase 4
- Intervention
- Darifenacin
- Conditions
- Urinary Incontinence
- Sponsor
- Novartis
- Enrollment
- 395
- Locations
- 65
- Primary Endpoint
- Change from baseline in average number of urinations per patient per day at Week 12
- Status
- Completed
- Last Updated
- 18 years ago
Overview
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.
Investigators
Eligibility 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
Arms & Interventions
1
Darifenacin
Intervention: Darifenacin
2
Darifenacin in combination with Behavioral Modification Programme for Symptoms of Overactive Bladder
Intervention: Darifenacin
2
Darifenacin in combination with Behavioral Modification Programme for Symptoms of Overactive Bladder
Intervention: Behavioral therapy
Outcomes
Primary Outcomes
Change from baseline in average number of urinations per patient per day at Week 12
Secondary Outcomes
- 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)
Study Sites (65)
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