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A Research Study for Patients With Overactive Bladder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00168454
First received: September 12, 2005
Last updated: October 11, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Overactive Bladder
Urinary Incontinence
Biological: botulinum toxin Type A
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Change in Number of Urinary Urge Incontinence Episodes [ Time Frame: Baseline, Week 2, Week 6, Week 12 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Change in Number of Micturitions [ Time Frame: Baseline, Week 2, Week 6, Week 12 ] [ Designated as safety issue: No ]
    Mean number of micturitions measured over a 7 day diary prior to each visit. Micturation is defined as urinating into the toilet.

  • Change in Number of Nocturia Episodes [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    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.

  • Maximum Cystometric Capacity (MCC) by Urodynamic Measurements [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    Maximum Cystometric Capacity (maximum volume that the bladder can hold) measured in mean milliliters

  • Incontinence Quality of Life Instrument (I-QOL) [ Time Frame: Baseline, Week 2, Week 6, Week 12 ] [ Designated as safety issue: No ]
    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.


Enrollment: 313
Study Start Date: July 2005
Study Completion Date: June 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo (normal saline) injected into detrusor on Day 1
Drug: Placebo
Placebo (normal saline) injected into detrusor on Day 1
Experimental: BOTOX 50 U
botulinum toxin Type A 50 U injected into detrusor on Day 1
Biological: botulinum toxin Type A
botulinum toxin Type A injected into detrusor on Day 1
Other Name: BOTOX®
Experimental: BOTOX 100 U
botulinum toxin Type A 100 U injected into detrusor on Day 1
Biological: botulinum toxin Type A
botulinum toxin Type A injected into detrusor on Day 1
Other Name: BOTOX®
Experimental: BOTOX 150 U
botulinum toxin Type A 150 U injected into detrusor on Day 1
Biological: botulinum toxin Type A
botulinum toxin Type A injected into detrusor on Day 1
Other Name: BOTOX®
Experimental: BOTOX 200 U
botulinum toxin Type A 200 U injected into detrusor on Day 1
Biological: botulinum toxin Type A
botulinum toxin Type A injected into detrusor on Day 1
Other Name: BOTOX®
Experimental: BOTOX 300 U
botulinum toxin Type A 300 U injected into detrusor on Day 1
Biological: botulinum toxin Type A
botulinum toxin Type A injected into detrusor on Day 1
Other Name: BOTOX®

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00168454

Locations
United States, Pennsylvania
Pittsburgh, Pennsylvania, United States
Belgium
Ghent, Belgium
Canada, British Columbia
Victoria, British Columbia, Canada
Germany
Berlin, Germany
Poland
Warsaw, Poland
United Kingdom
Sheffield, United Kingdom
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided by Allergan

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00168454     History of Changes
Other Study ID Numbers: 191622-077
Study First Received: September 12, 2005
Results First Received: September 2, 2009
Last Updated: October 11, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Incontinence
Lower Urinary Tract Symptoms
Signs and Symptoms
Urinary Bladder Diseases
Urination Disorders
Urologic Diseases
Urological Manifestations
Botulinum Toxins
Botulinum Toxins, Type A
Anti-Dyskinesia Agents
Central Nervous System Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014