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Completed

NCT Number: NCT01945489

OnabotulinumtoxinA (BOTOX®) Treatment for Urinary Incontinence in Patients With Overactive Bladder

This is a study to evaluate the efficacy and safety of onabotulinumtoxinA (BOTOX®) compared with placebo, in achieving a 100% reduction in urinary incontinence in patients with overactive bladder (OAB) not properly managed with an anticholinergic.

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Key information

Conditions

Overactive Bladder 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 Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Urologic Clinics of North Alabama, Huntsville, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

-Patients with symptoms of Overactive Bladder (OAB) (frequency and urgency) with urinary incontinence for at least 6 months prior to screening.

Exclusion criteria

  • Symptoms of OAB due to a neurological reason
  • Use of anticholinergics or other medications or therapies to treat symptoms of OAB within 7 days of screening
  • Use of Clean Intermittent Catheterization (CIC) or indwelling catheter to manage urinary incontinence
  • Use of botulinum toxin therapy of any serotype for any urological condition
  • Use of botulinum toxin therapy of any serotype for any non-urological condition in the 12 weeks prior to screening
  • History of any pelvic or urological abnormalities, bladder surgery or disease, other than OAB, that may affect bladder function
  • Diagnosis of Myasthenia gravis, Eaton-Lambert syndrome, or Amyotrophic Lateral Sclerosis.

Treatment and study plan

onabotulinumtoxinA

Biological

OnabotulinumtoxinA (BOTOX®) injected into the detrusor.

Other names: BOTOX®, botulinum toxin Type A

normal saline

Drug

Normal saline (placebo) injected into the detrusor.

Primary outcomes

  1. Percentage of Participants Who Achieve a 100% Reduction in Urinary Incontinence Episodes

    Time frame: Baseline, Week 12

    Urinary incontinence is defined as involuntary loss of urine as recorded by the participant in a bladder diary during the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of incontinence episodes were averaged daily during this period and compared to baseline to determine 100% reduction in episodes.

  2. Change From Baseline in the Daily Average Number of Episodes of Urinary Incontinence

    Time frame: Baseline, Week 12

    Urinary incontinence is defined as involuntary loss of urine as recorded by the participant in a bladder diary during the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of incontinence episodes were averaged daily during this period. A negative number change from Baseline indicates an improvement and a positive number change from Baseline indicates a worsening.

Secondary outcomes

  1. Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores

    Time frame: Baseline, Week 12

    The King's Health Questionnaire is a disease-specific questionnaire that measures the quality of life of participants with urinary incontinence. The questionnaire consists of 7 domains, including emotions, personal relationships, physical limitations, role limitations, severity (coping) measures, sleep/energy and social limitations. Domain scores range from 0 to 100, with a lower score indicating a preferable health status (absence of urinary incontinence impacts). A negative number change from Baseline indicates improvement and a positive number change from Baseline indicates a worsening.

  2. Change From Baseline in the Daily Average Number of Micturition Episodes

    Time frame: Baseline, Week 12

    The number of micturition episodes (the number of times a patient urinates into the toilet) in Treatment Cycle 1 was recorded by the participant in a bladder diary during the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of micturition episodes were averaged daily during this period A negative number change from Baseline indicates an improvement and a positive number change from Baseline indicates a worsening.

  3. Change From Baseline in the Daily Average Number of Urgency Episodes

    Time frame: Baseline, Week 12

    The number of daily urgency episodes (the number of times a patient experiences the urgency to urinate) in Treatment Cycle 1 was recorded by the patient in a bladder diary during the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of urgency episodes were averaged daily during this period A negative number change from Baseline indicates an improvement and a positive number change from Baseline indicates a worsening.

  4. Change From Baseline in the Daily Average Number of Nocturia Episodes

    Time frame: Baseline, Week 12

    Nocturia episodes were recorded by the participant in a bladder diary during the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of nocturia episodes were averaged daily during this period. A nocturia episode is a void (urinating into the toilet) that interrupts one's sleep. A negative number change from Baseline indicates an improvement and a positive number change from baseline indicates a worsening.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Acronym: COMFORT

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Sep 18, 2013
Registry last updated
Nov 6, 2017

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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