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

NCT00910845 | Completed Phase 3 Results

• 1 other identifier: 191622-095
• Study Type: interventional
• Target: 557
• Locations: 2 countries
• Sites: 2

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.

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline, Week 12

Secondary Outcomes (2)

• Change From Baseline in Number of Daily Micturition Episodes

  Baseline, Week 12

• Change From Baseline in Volume Voided Per Micturition

  Baseline, Week 12

Study Arms (2)

onabotulinumtoxinA

EXPERIMENTAL

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).

Biological: onabotulinumtoxinA

placebo/onabotulinumtoxinA

OTHER

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).

Biological: onabotulinumtoxinA; Drug: normal saline

Interventions

onabotulinumtoxinA BIOLOGICAL

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).

Also known as: BOTOX®, botulinum toxin Type A

onabotulinumtoxinA; placebo/onabotulinumtoxinA

normal saline DRUG

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

placebo/onabotulinumtoxinA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Allergan: lead

Study Sites (2)

Unknown Facility

Newport Beach, California, United States

Location

Unknown Facility

Victoria, British Columbia, Canada

Location

Related Publications (3)

• 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.

  PMID: 32665528 DERIVED

• 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.

  PMID: 26231052 DERIVED

• 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.

  PMID: 24754838 DERIVED

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Botulinum Toxins, Type A; Saline Solution

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Therapeutic Area Head,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2009
• First Posted: June 1, 2009
• Study Start: September 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: March 5, 2013
• Results First Posted: March 5, 2013

Record last verified: 2013-01

Locations

US (1); CA (1)