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Completed

NCT Number: NCT00127270

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

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.

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Key information

Conditions

Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urinary Incontinence, Urge Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Alabama Research Center, Birmingham, Alabama, United States

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Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Darifenacin

Drug

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

Other names: Enablex

Behavioral therapy

Behavioral

Behavioral Modification Programme for symptoms of overactive bladder

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)

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Collaborators

  • Procter and Gamble

Registry information

Official study title

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

Important dates

Study start
2005
Study completion
2006
First posted
Aug 5, 2005
Registry last updated
Jan 24, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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