BOTOX® in the Treatment of Urinary Incontinence Due to Overactive Bladder in Patients 12 to 17 Years of Age
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Urinary Incontinence
- Sponsor
- Allergan
- Enrollment
- 56
- Locations
- 39
- Primary Endpoint
- Change From Study Baseline in the Daily Normalized Daytime Average Number of Urinary Incontinence Episodes in Treatment Cycle 1
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
Brief Summary
This was a multicenter, randomized, double-blind, parallel-group, multiple-dose study to evaluate the efficacy and safety of BOTOX in adolescents with urinary incontinence due to overactive bladder (OAB) with inadequate management with anticholinergic therapy. Participants were randomized in a 1:1:1 ratio to receive a single Tx of 25 U, 50 U, or 100 U BOTOX (not to exceed 6 U/kg) on Day 1, were seen after each treatment at Weeks 2, 6, and 12 post-treatment, and thereafter at alternating telephone and clinic visits every 6 weeks until they qualified for further retreatment/exited the study. Participants could receive multiple treatments dependent upon the number and timing of patient requests/qualification for retreatment. At each retreatment the investigator could keep the dose the same or increase it one dose level in a blinded fashion. Participants exited the study once 96 weeks have elapsed since entry on Day 1 and at least 12 weeks follow-up since their last study treatment had occurred.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Symptoms of overactive bladder (OAB) (frequency/urgency) with urinary incontinence for at least 6 months
- •OAB symptoms not adequately managed by 1 or more anticholinergic agents
- •Exclusion Criteria
- •OAB caused by a neurological condition
- •Use of anticholinergics or other medications to treat OAB symptoms within 7 days
- •Current use of indwelling catheter or clean intermittent catheterization to empty the bladder
- •Previous or current use of botulinum toxin therapy of any serotype for any urological condition, or treatment with botulinum toxin of any serotype within 3 months for any other condition or use
- •Myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change From Study Baseline in the Daily Normalized Daytime Average Number of Urinary Incontinence Episodes in Treatment Cycle 1
Time Frame: From Baseline to 2 consecutive days in the week prior to Week 12 in Treatment Cycle 1
Urinary incontinence was defined as involuntary loss of urine as recorded by the participant in a bladder diary during 2 consecutive days in the week prior to the study visit (normalized to a 12 hour daytime period). Daytime is defined as the time between waking up to start the day and going to bed to sleep for the night. The number of daily daytime incontinence episodes were averaged during the 2-day period. A negative change from Baseline indicates improvement. Data are summarized per the respective treatments that participants received in the corresponding treatment cycle.
Secondary Outcomes
- Change From Study Baseline in the Daily Average Frequency of Normalized Daytime Micturition Episodes(From Baseline to 2 consecutive days in the week prior to Week 12 in Treatment Cycle 1)
- Change From Study Baseline in the Daily Average Frequency of Normalized Daytime Urgency Episodes(From Baseline to 2 consecutive days in the week prior to Week 12 in Treatment Cycle 1)
- Percentage of Participants With Night Time Urinary Incontinence(From Baseline to 2 consecutive days in the week prior to Week 12 in Treatment Cycle 1)
- Change From Study Baseline in the Daily Average Volume Voided Per Micturition (mL)(From Baseline to 2 consecutive days in the week prior to Week 12 in Treatment Cycle 1)
- Change From Study Baseline in Pediatric Urinary Incontinence Quality of Life Total Score (PinQ)(From Day 1 Prior to Treatment to Week 12 in Treatment Cycle 1)
- Change From Study Baseline in PinQ Item 'I am Worried That People Might Think my Clothes Smell Like Pee"(From Day 1 Prior to Treatment to Week 12 in Treatment Cycle 1)
- Change From Study Baseline in PinQ Item 'My Bladder Problem Makes me Feel Bad About Myself"(From Day 1 Prior to Treatment to Week 12 in Treatment Cycle 1)
- Change From Study Baseline in PinQ Item 'I Miss Out on Being With Friends Because of my Bladder Problems"(From Day 1 Prior to Treatment to Week 12 in Treatment Cycle 1)
- Percentage of Participants With a Positive Treatment Response in the Modified Treatment Benefit Scale(At Week 12 in Treatment Cycle 1)
- Time to Participant's First Request for Retreatment(From the day of BOTOX treatment in Treatment Cycle 1 to the request for subsequent treatment)
- Time to Participant's Qualification for Retreatment(From the day of BOTOX treatment in Treatment Cycle 1 to the qualification for retreatment)