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A Research Study for Patients With Overactive Bladder

Primary Purpose

Overactive Bladder, Urinary Incontinence

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

botulinum toxin Type A

Placebo

About this trial

This is an interventional treatment trial for Overactive Bladder

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

BOTOX 50 U

BOTOX 100 U

BOTOX 150 U

BOTOX 200 U

BOTOX 300 U

Arm Description

Placebo (normal saline) injected into detrusor on Day 1

botulinum toxin Type A 50 U injected into detrusor on Day 1

botulinum toxin Type A 100 U injected into detrusor on Day 1

botulinum toxin Type A 150 U injected into detrusor on Day 1

botulinum toxin Type A 200 U injected into detrusor on Day 1

botulinum toxin Type A 300 U injected into detrusor on Day 1

Outcomes

Primary Outcome Measures

Change in Number of Urinary Urge Incontinence Episodes

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

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

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

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

Incontinence Quality of Life Instrument (I-QOL)

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.

Full Information

NCT ID

NCT00168454

First Posted

September 12, 2005

Last Updated

October 11, 2013

Sponsor

Allergan

1. Study Identification

Unique Protocol Identification Number

NCT00168454

Brief Title

A Research Study for Patients With Overactive Bladder

Study Type

Interventional

2. Study Status

Record Verification Date

October 2013

Overall Recruitment Status

Completed

Study Start Date

July 2005 (undefined)

Primary Completion Date

January 2008 (Actual)

Study Completion Date

June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Allergan

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overactive Bladder, Urinary Incontinence

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

313 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo (normal saline) injected into detrusor on Day 1

Arm Title

BOTOX 50 U

Arm Type

Experimental

Arm Description

botulinum toxin Type A 50 U injected into detrusor on Day 1

Arm Title

BOTOX 100 U

Arm Type

Experimental

Arm Description

botulinum toxin Type A 100 U injected into detrusor on Day 1

Arm Title

BOTOX 150 U

Arm Type

Experimental

Arm Description

botulinum toxin Type A 150 U injected into detrusor on Day 1

Arm Title

BOTOX 200 U

Arm Type

Experimental

Arm Description

botulinum toxin Type A 200 U injected into detrusor on Day 1

Arm Title

BOTOX 300 U

Arm Type

Experimental

Arm Description

botulinum toxin Type A 300 U injected into detrusor on Day 1

Intervention Type

Biological

Intervention Name(s)

botulinum toxin Type A

Other Intervention Name(s)

BOTOX®

Intervention Description

botulinum toxin Type A injected into detrusor on Day 1

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo (normal saline) injected into detrusor on Day 1

Primary Outcome Measure Information:

Title

Change in Number of Urinary Urge Incontinence Episodes

Description

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.

Time Frame

Baseline, Week 2, Week 6, Week 12

Secondary Outcome Measure Information:

Title

Change in Number of Micturitions

Description

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

Time Frame

Baseline, Week 2, Week 6, Week 12

Title

Change in Number of Nocturia Episodes

Description

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.

Time Frame

Baseline, Week 12

Title

Maximum Cystometric Capacity (MCC) by Urodynamic Measurements

Description

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

Time Frame

Baseline, Week 12

Title

Incontinence Quality of Life Instrument (I-QOL)

Description

Time Frame

Baseline, Week 2, Week 6, Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Allergan

Official's Role

Study Director

Facility Information:

City

Pittsburgh

State/Province

Pennsylvania

Country

United States

City

Ghent

Country

Belgium

City

Victoria

State/Province

British Columbia

Country

Canada

City

Berlin

Country

Germany

City

Warsaw

Country

Poland

City

Sheffield

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

22464310

Citation

Fowler CJ, Auerbach S, Ginsberg D, Hale D, Radziszewski P, Rechberger T, Patel VD, Zhou J, Thompson C, Kowalski JW. OnabotulinumtoxinA improves health-related quality of life in patients with urinary incontinence due to idiopathic overactive bladder: a 36-week, double-blind, placebo-controlled, randomized, dose-ranging trial. Eur Urol. 2012 Jul;62(1):148-57. doi: 10.1016/j.eururo.2012.03.005. Epub 2012 Mar 14.

Results Reference

derived

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A Research Study for Patients With Overactive Bladder

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