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Completed

NCT Number: NCT00168454

A Research Study for Patients With Overactive Bladder

The purpose of this study is to investigate whether injections of botulinum toxin Type A into the bladder are safe and effective in treating overactive bladder.

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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 Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ghent, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Must be between 18-85 years old
  • Must have been diagnosed by his/her doctor with overactive bladder at least 6 months ago
  • Must weigh at least 50 kg (110 lbs)
  • Must be willing and able to record information regarding bladder function into a diary (provided)
  • Must be willing and able to complete the entire course of the study

Exclusion criteria

  • Cannot currently be catheterizing as a way to control incontinence
  • Must not have used botulinum toxin type A or any other botulinum toxin previously for any condition

Treatment and study plan

Botulinum toxin type A

Biological

botulinum toxin Type A injected into detrusor on Day 1

Other names: BOTOX®

Placebo

Drug

Placebo (normal saline) injected into detrusor on Day 1

Primary outcomes

  1. Change in Number of Urinary Urge Incontinence Episodes

    Time frame: Baseline, Week 2, Week 6, Week 12

    Mean number of urinary urge incontinence episodes measured over a 7-day diary prior to week 12. Urinary urge incontinence is defined as urinary leakage associated with a strong desire to urinate.

Secondary outcomes

  1. Change in Number of Micturitions

    Time frame: Baseline, Week 2, Week 6, Week 12

    Mean number of micturitions measured over a 7 day diary prior to each visit. Micturation is defined as urinating into the toilet.

  2. Change in Number of Nocturia Episodes

    Time frame: Baseline, Week 12

    Mean number of nocturia episodes measured over a 7 day diary prior to each visit. A nocturia episode is a void (urinating into the toilet) that interrupts one's sleep.

  3. Maximum Cystometric Capacity (MCC) by Urodynamic Measurements

    Time frame: Baseline, Week 12

    Maximum Cystometric Capacity (maximum volume that the bladder can hold) measured in mean milliliters

  4. Incontinence Quality of Life Instrument (I-QOL)

    Time frame: Baseline, Week 2, Week 6, Week 12

    Measured on 3 domains; a 5-point scale (1-5) for each domain. Sum of the domain scores is normalized to a scale of 0-100 (100 = no impact of incontinence on daily activities, 0 = maximum impact of incontinence on daily activities). Mean scores presented.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Sep 15, 2005
Registry last updated
Nov 6, 2013

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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