A Research Study for Patients With Overactive Bladder

NCT00168454 | Completed Phase 2 Results DMC

• 1 other identifier: 191622-077
• Study Type: interventional
• Target: 313
• Locations: 6 countries
• Sites: 6

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.

Conditions

Overactive Bladder; Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Week 2, Week 6, Week 12

Secondary Outcomes (4)

• Change in Number of Micturitions

  Baseline, Week 2, Week 6, Week 12

• Change in Number of Nocturia Episodes

  Baseline, Week 12

• Maximum Cystometric Capacity (MCC) by Urodynamic Measurements

  Baseline, Week 12

• Incontinence Quality of Life Instrument (I-QOL)

  Baseline, Week 2, Week 6, Week 12

Study Arms (6)

Placebo

PLACEBO COMPARATOR

Placebo (normal saline) injected into detrusor on Day 1

Drug: Placebo

BOTOX 50 U

EXPERIMENTAL

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

Biological: botulinum toxin Type A

BOTOX 100 U

EXPERIMENTAL

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

Biological: botulinum toxin Type A

BOTOX 150 U

EXPERIMENTAL

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

Biological: botulinum toxin Type A

BOTOX 200 U

EXPERIMENTAL

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

Biological: botulinum toxin Type A

BOTOX 300 U

EXPERIMENTAL

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

Biological: botulinum toxin Type A

Interventions

botulinum toxin Type A BIOLOGICAL

botulinum toxin Type A injected into detrusor on Day 1

Also known as: BOTOX®

BOTOX 100 U; BOTOX 150 U; BOTOX 200 U; BOTOX 300 U; BOTOX 50 U

Placebo DRUG

Placebo (normal saline) injected into detrusor on Day 1

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergan: lead

Study Sites (6)

Unknown Facility

Pittsburgh, Pennsylvania, United States

Location

Unknown Facility

Ghent, Belgium

Location

Unknown Facility

Victoria, British Columbia, Canada

Location

Unknown Facility

Berlin, Germany

Location

Unknown Facility

Warsaw, Poland

Location

Unknown Facility

Sheffield, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 22464310 DERIVED

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence

Interventions

Botulinum Toxins, Type A

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; Urination Disorders

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

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: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: September 12, 2005
• First Posted: September 15, 2005
• Study Start: July 1, 2005
• Primary Completion: January 1, 2008
• Study Completion: June 1, 2008
• Last Updated: November 6, 2013
• Results First Posted: February 11, 2010

Record last verified: 2013-10

Locations

GB (1); US (1); DE (1); CA (1); BE (1); PL (1)