A Research Study for Patients With Overactive Bladder

October 11, 2013 updated by: Allergan
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

313

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • BOTOX®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Week 2, Week 6, Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Week 2, Week 6, Week 12
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.
Baseline, Week 12
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
Baseline, Week 12
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.
Baseline, Week 2, Week 6, Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

November 6, 2013

Last Update Submitted That Met QC Criteria

October 11, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 191622-077

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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