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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00127270
First Posted: August 5, 2005
Last Update Posted: January 24, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Procter and Gamble
Information provided by:
Novartis
  Purpose
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.

Condition Intervention Phase
Urinary Incontinence Drug: Darifenacin Behavioral: Behavioral therapy Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Using Behavioral Therapy in Combination With Drug-Darifenacin for Symptoms of Overactive Bladder

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change from baseline in average number of urinations per patient per day at Week 12

Secondary Outcome Measures:
  • 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)

Enrollment: 395
Study Start Date: May 2005
Study Completion Date: February 2006
Arms Assigned Interventions
Experimental: 1
Darifenacin
Drug: Darifenacin
Darifenacin tablets 7,5 mg once daily with the possibility to up-titrate to 15 mg once daily
Other Name: Enablex
2
Darifenacin in combination with Behavioral Modification Programme for Symptoms of Overactive Bladder
Drug: Darifenacin
Darifenacin tablets 7,5 mg or 15 mg once daily
Behavioral: Behavioral therapy
Behavioral Modification Programme for symptoms of overactive bladder

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00127270


  Show 67 Study Locations
Sponsors and Collaborators
Novartis
Procter and Gamble
Investigators
Study Director: Novartis Pharmaceuticals Corp. Novartis Pharmaceutical
  More Information

Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00127270     History of Changes
Other Study ID Numbers: CDAR328AUS01
First Submitted: June 30, 2005
First Posted: August 5, 2005
Last Update Posted: January 24, 2008
Last Verified: January 2008

Keywords provided by Novartis:
OAB
Overactive Bladder
Bladder hyperactivity
Urge Incontinence
Incontinence
Bladder

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urinary Bladder, Overactive
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Urinary Bladder Diseases
Darifenacin
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents