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Study of Botulinum Toxin Type A for the Treatment of Patients With Idiopathic Overactive Bladder With Urinary Incontinence

Primary Purpose

Overactive Bladder

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

onabotulinumtoxinA

normal saline

About this trial

This is an interventional treatment trial for Overactive Bladder

Eligibility Criteria

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

Inclusion Criteria:

Symptoms of OAB (frequency/urgency) with urinary incontinence for at least 6 months
Inadequate response or limiting side effects with anticholinergics for the treatment of OAB

Exclusion Criteria:

Overactive Bladder caused by neurological condition
Patient has predominance of stress incontinence
History or evidence of pelvic or urological abnormality

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

onabotulinumtoxinA

placebo/onabotulinumtoxinA

Arm Description

OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).

Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).

Outcomes

Primary Outcome Measures

Change From Baseline in Number of Daily Episodes of Urinary Incontinence

A urinary incontinence episode is defined as an incident of involuntary loss of urine as recorded in a patient bladder diary during the 3 days before the Baseline and Week 12 study visits. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).

Secondary Outcome Measures

Change From Baseline in Number of Daily Micturition Episodes

The number of micturition episodes (the number of times a patient urinates into the toilet) was recorded by the patient in a bladder diary during 3 consecutive days in the week prior to the Baseline and prior to the Week 12 study visit. A negative number change from baseline indicates a reduction in micturition episodes (improvement).

Change From Baseline in Volume Voided Per Micturition

The total volume voided was measured over one 24-hour period in the week prior to the Baseline and Week 12 study visit and recorded by the patient in the bladder diary. This was used to calculate volume voided per micturition. A positive number change from baseline indicates an increase in volume voided per micturition (improvement).

Full Information

NCT ID

NCT00910845

First Posted

May 28, 2009

Last Updated

January 29, 2013

Sponsor

Allergan

1. Study Identification

Unique Protocol Identification Number

NCT00910845

Brief Title

Study of Botulinum Toxin Type A for the Treatment of Patients With Idiopathic Overactive Bladder With Urinary Incontinence

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Completed

Study Start Date

September 2009 (undefined)

Primary Completion Date

July 2011 (Actual)

Study Completion Date

July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Allergan

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to assess the safety and effectiveness of botulinum toxin type A (onabotulinumtoxinA) in treating patients with idiopathic overactive bladder with urinary incontinence.

6. Conditions and Keywords

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

Overactive Bladder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

557 (Actual)

8. Arms, Groups, and Interventions

Arm Title

onabotulinumtoxinA

Arm Type

Experimental

Arm Description

OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).

Arm Title

placebo/onabotulinumtoxinA

Arm Type

Other

Arm Description

Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).

Intervention Type

Biological

Intervention Name(s)

onabotulinumtoxinA

Other Intervention Name(s)

BOTOX®, botulinum toxin Type A

Intervention Description

OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable). Or, if placebo is administered at Day 1, onabotulinumtoxinA 100 U injected after a minimum of 12 weeks (if applicable).

Intervention Type

Drug

Intervention Name(s)

normal saline

Intervention Description

Normal saline (placebo) injected into the detrusor at Day 1.

Primary Outcome Measure Information:

Title

Change From Baseline in Number of Daily Episodes of Urinary Incontinence

Description

Time Frame

Baseline, Week 12

Secondary Outcome Measure Information:

Title

Change From Baseline in Number of Daily Micturition Episodes

Description

Time Frame

Baseline, Week 12

Title

Change From Baseline in Volume Voided Per Micturition

Description

Time Frame

Baseline, Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Symptoms of OAB (frequency/urgency) with urinary incontinence for at least 6 months Inadequate response or limiting side effects with anticholinergics for the treatment of OAB Exclusion Criteria: Overactive Bladder caused by neurological condition Patient has predominance of stress incontinence History or evidence of pelvic or urological abnormality

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Allergan

Official's Role

Study Director

Facility Information:

City

Newport Beach

State/Province

California

Country

United States

City

Victoria

State/Province

British Columbia

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

32665528

Citation

McCammon K, Gousse A, Kohan A, Glazier D, Gruenenfelder J, Bai Z, Patel A, Hale D. Early and Consistent Improvements in Urinary Symptoms and Quality of Life With OnabotulinumtoxinA in Patients With Overactive Bladder and Urinary Incontinence: Results From a Randomized, Placebo-controlled, Phase IV Clinical Trial. Female Pelvic Med Reconstr Surg. 2021 Jul 1;27(7):450-456. doi: 10.1097/SPV.0000000000000914.

Results Reference

derived

PubMed Identifier

26231052

Citation

Castejon N, Khalaf K, Ni Q, Cuervo J, Patrick DL. Psychometric properties of the incontinence utility index among patients with idiopathic overactive bladder: data from two multicenter, double-blind, randomized, Phase 3, placebo-controlled clinical trials. Health Qual Life Outcomes. 2015 Aug 1;13:116. doi: 10.1186/s12955-015-0306-5.

Results Reference

derived

PubMed Identifier

24754838

Citation

Sievert KD, Chapple C, Herschorn S, Joshi M, Zhou J, Nardo C, Nitti VW. OnabotulinumtoxinA 100U provides significant improvements in overactive bladder symptoms in patients with urinary incontinence regardless of the number of anticholinergic therapies used or reason for inadequate management of overactive bladder. Int J Clin Pract. 2014 Oct;68(10):1246-56. doi: 10.1111/ijcp.12443. Epub 2014 Apr 22.

Results Reference

derived

Learn more about this trial

Study of Botulinum Toxin Type A for the Treatment of Patients With Idiopathic Overactive Bladder With Urinary Incontinence

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