OnabotulinumtoxinA for the Treatment of Urinary Incontinence Due to Overactive Bladder in Pediatric Patients (12 to 17)

Stopped early · Phase 3

Conditions studied: Urinary Incontinence, Urinary Bladder, Overactive

In brief

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.

Key facts

Study ID

NCT02097121

Run by

Allergan

People needed

56

Starts

2014-05-23

Expected to finish

2022-02-10

Last updated by the study team

2022-12-28

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Alaska Urological Institute /ID# 238189 — Anchorage, Alaska, United States
• Arkansas Children's Hospital /ID# 237787 — Little Rock, Arkansas, United States
• Children's Hospital Colorado /ID# 237621 — Aurora, Colorado, United States
• Yale New Haven Hospital - Yale School of Medicine /ID# 238222 — New Haven, Connecticut, United States
• Orlando Health-Arnold Palmer Hospital for Children Pediatric Urology /ID# 235283 — Orlando, Florida, United States
• Associated Urologist of North Carolina /ID# 235437 — Raleigh, North Carolina, United States
• Cook Children's Med. Center /ID# 237539 — Fort Worth, Texas, United States
• Children's Hospital Wisconsin - Milwaukee Campus /ID# 237544 — Milwaukee, Wisconsin, United States
• Sydney Children's Hospital /ID# 237191 — Randwick, New South Wales, Australia
• The Children's Hospital at Westmead /ID# 234337 — Sydney, New South Wales, Australia
• Monash Children's Hospital /ID# 234388 — Clayton, Victoria, Australia
• Universitair Ziekenhuis Antwerpen /ID# 237997 — Edegem, Antwerpen, Belgium
• UZ Gent /ID# 237588 — Ghent, Oost-Vlaanderen, Belgium
• Universitair Ziekenhuis Leuven /ID# 237218 — Leuven, Vlaams-Brabant, Belgium
• Alberta Children's Hospital /ID# 237510 — Calgary, Alberta, Canada
• London Health Sciences Center /ID# 234304 — London, Ontario, Canada
• CHUS - Hopital Fleurimont /ID# 237668 — Sherbrooke, Quebec, Canada
• Fakultni nemocnice Olomouc /ID# 237577 — Olomouc, Czechia
• Duplicate_CHU Bordeaux-Hopital Pellegrin /ID# 237392 — Bordeaux, France
• Hôpital de la Mère et de l'Enfant /ID# 235227 — Limoges, France
• Hôpitaux Pédiatriques de Nice CHU-LENVAL /ID# 235278 — Nice, France
• Evangelisches Krankenhaus Bielefeld /ID# 235234 — Bielefeld, Germany
• Urologische Gemeinschaftspraxis /ID# 234978 — Emmendingen, Germany
• Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 234288 — Lübeck, Germany
• AOU Universita degli Studi della Campania Luigi Vanvitelli /ID# 237308 — Naples, Italy

Full record on ClinicalTrials.gov

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