OnabotulinumtoxinA (BOTOX®) Treatment for Urinary Incontinence in Patients With Overactive Bladder

Phase 4

Completed

• Conditions: Overactive Bladder
• Interventions: Biological: onabotulinumtoxinA; Drug: Normal saline

• Registration Number: NCT01945489
• Lead Sponsor: Allergan

Brief Summary

This is a study to evaluate the efficacy and safety of onabotulinumtoxinA (BOTOX®) compared with placebo, in achieving a 100% reduction in urinary incontinence in patients with overactive bladder (OAB) not properly managed with an anticholinergic.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-16
• Study First Submitted QC: 2013-09-16
• Study First Posted: 2013-09-18
• Study Start: 2013-10-28
• Primary Completion: 2016-05-24
• Study Completion: 2017-01-05
• Results First Submitted: 2017-07-25
• Status Verified: 2017-09
• Results First Submitted QC: 2017-10-03
• Last Update Submitted: 2017-10-03
• Results First Posted: 2017-11-06
• Last Update Posted: 2017-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 254

Inclusion Criteria

-Patients with symptoms of Overactive Bladder (OAB) (frequency and urgency) with urinary incontinence for at least 6 months prior to screening.

Exclusion Criteria

• Symptoms of OAB due to a neurological reason
• Use of anticholinergics or other medications or therapies to treat symptoms of OAB within 7 days of screening
• Use of Clean Intermittent Catheterization (CIC) or indwelling catheter to manage urinary incontinence
• Use of botulinum toxin therapy of any serotype for any urological condition
• Use of botulinum toxin therapy of any serotype for any non-urological condition in the 12 weeks prior to screening
• History of any pelvic or urological abnormalities, bladder surgery or disease, other than OAB, that may affect bladder function
• Diagnosis of Myasthenia gravis, Eaton-Lambert syndrome, or Amyotrophic Lateral Sclerosis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo/OnabotulinumtoxinA	onabotulinumtoxinA	Placebo (Normal saline) injected into the detrusor on Day 1, followed by an injection of onabotulinumtoxinA 100U after a minimum of 12 weeks (if applicable).
OnabotulinumtoxinA	onabotulinumtoxinA	OnabotulinumtoxinA (BOTOX®) 100U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100U after a minimum of 12 weeks (if applicable).
Placebo/OnabotulinumtoxinA	Normal saline	Placebo (Normal saline) injected into the detrusor on Day 1, followed by an injection of onabotulinumtoxinA 100U after a minimum of 12 weeks (if applicable).

Primary Outcome Measures

Name	Time	Method
Change From Baseline in the Daily Average Number of Episodes of Urinary Incontinence	Baseline, Week 12	Urinary incontinence is defined as involuntary loss of urine as recorded by the participant in a bladder diary during the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of incontinence episodes were averaged daily during this period. A negative number change from Baseline indicates an improvement and a positive number change from Baseline indicates a worsening.
Percentage of Participants Who Achieve a 100% Reduction in Urinary Incontinence Episodes	Baseline, Week 12	Urinary incontinence is defined as involuntary loss of urine as recorded by the participant in a bladder diary during the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of incontinence episodes were averaged daily during this period and compared to baseline to determine 100% reduction in episodes.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in the Daily Average Number of Nocturia Episodes	Baseline, Week 12	Nocturia episodes were recorded by the participant in a bladder diary during the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of nocturia episodes were averaged daily during this period. A nocturia episode is a void (urinating into the toilet) that interrupts one's sleep. A negative number change from Baseline indicates an improvement and a positive number change from baseline indicates a worsening.
Change From Baseline in the Daily Average Number of Urgency Episodes	Baseline, Week 12	The number of daily urgency episodes (the number of times a patient experiences the urgency to urinate) in Treatment Cycle 1 was recorded by the patient in a bladder diary during the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of urgency episodes were averaged daily during this period A negative number change from Baseline indicates an improvement and a positive number change from Baseline indicates a worsening.
Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores	Baseline, Week 12	The King's Health Questionnaire is a disease-specific questionnaire that measures the quality of life of participants with urinary incontinence. The questionnaire consists of 7 domains, including emotions, personal relationships, physical limitations, role limitations, severity (coping) measures, sleep/energy and social limitations. Domain scores range from 0 to 100, with a lower score indicating a preferable health status (absence of urinary incontinence impacts). A negative number change from Baseline indicates improvement and a positive number change from Baseline indicates a worsening.
Change From Baseline in the Daily Average Number of Micturition Episodes	Baseline, Week 12	The number of micturition episodes (the number of times a patient urinates into the toilet) in Treatment Cycle 1 was recorded by the participant in a bladder diary during the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of micturition episodes were averaged daily during this period A negative number change from Baseline indicates an improvement and a positive number change from Baseline indicates a worsening.

Trial Locations

Locations (39)

Urologic Clinics of North Alabama; 🇺🇸 Huntsville, Alabama, United States

Alaska Urological Institute dba Alaska Clinical Research Center; 🇺🇸 Anchorage, Alaska, United States

South Orange County Medical Research Center; 🇺🇸 Laguna Hills, California, United States

University of Southern California; 🇺🇸 Los Angeles, California, United States

Genesis Research LLC; 🇺🇸 San Diego, California, United States

U. Colorado, School of Med.; 🇺🇸 Aurora, Colorado, United States

Genitourinary Surgical Consultants; 🇺🇸 Denver, Colorado, United States

Urology Associates of Norwalk; 🇺🇸 Norwalk, Connecticut, United States

Sunrise Medical Research; 🇺🇸 Lauderdale Lakes, Florida, United States

Bladder and Prostate Health Investigations, LLC; 🇺🇸 Miramar, Florida, United States

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