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

NCT ID: NCT02097121

Last Updated: 2022-12-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-23
• Study Completion Date: 2022-02-10

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.

Conditions

Urinary Incontinence; Urinary Bladder; Overactive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Botox 25 U

Participants randomized to receive 25 Units (U) BOTOX (not to exceed 6 U/kg), administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone. Posttreatment follow-up clinic visits occurred at Weeks 2, 6, and 12. Participants could request retreatment from Week 12 and 12 weeks after each subsequent treatment for up to 4 cycles. The retreatment dose was determined by the Investigator and could be at the same dose or at the next higher dose compared with the preceding treatment.

Group Type: EXPERIMENTAL

BOTOX®

Intervention Type: BIOLOGICAL

Each vial of BOTOX (Botulinum Toxin Type A) purified neurotoxin complex, formulation No. 9060X contains 100 U of Clostridium botulinum toxin Type A, 0.5 mg albumin (human), and 0.9 mg sodium chloride in a sterile, vacuum-dried form without a preservative. The study medication was to be reconstituted with 0.9% sodium chloride (preservative-free). The 10 mL of study drug was to be administered as 20 injections each of 0.5 mL. Under direct cystoscopic visualization, injections were to be distributed evenly across the detrusor wall and spaced approximately 1 cm apart. To avoid injecting the trigone, the injections were to be at least 1 cm above the trigone. The injection needle was to be inserted approximately 2 mm into the detrusor for each injection.

Botox 50 U

Participants randomized to receive 50 Units (U) BOTOX (not to exceed 6 U/kg), administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone. Posttreatment follow-up clinic visits occurred at Weeks 2, 6, and 12. Participants could request retreatment from Week 12 and 12 weeks after each subsequent treatment for up to 4 cycles. The retreatment dose was determined by the Investigator and could be at the same dose or at the next higher dose compared with the preceding treatment.

Group Type: EXPERIMENTAL

BOTOX®

Intervention Type: BIOLOGICAL

Each vial of BOTOX (Botulinum Toxin Type A) purified neurotoxin complex, formulation No. 9060X contains 100 U of Clostridium botulinum toxin Type A, 0.5 mg albumin (human), and 0.9 mg sodium chloride in a sterile, vacuum-dried form without a preservative. The study medication was to be reconstituted with 0.9% sodium chloride (preservative-free). The 10 mL of study drug was to be administered as 20 injections each of 0.5 mL. Under direct cystoscopic visualization, injections were to be distributed evenly across the detrusor wall and spaced approximately 1 cm apart. To avoid injecting the trigone, the injections were to be at least 1 cm above the trigone. The injection needle was to be inserted approximately 2 mm into the detrusor for each injection.

Botox 100 U

Participants randomized to receive 100 Units (U) BOTOX (not to exceed 6 U/kg), administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone. Posttreatment follow-up clinic visits occurred at Weeks 2, 6, and 12. Participants could request retreatment from Week 12 and 12 weeks after each subsequent treatment for up to 4 cycles. The retreatment dose was determined by the Investigator and could be at the same dose or at the next higher dose compared with the preceding treatment.

Group Type: EXPERIMENTAL

BOTOX®

Intervention Type: BIOLOGICAL

Each vial of BOTOX (Botulinum Toxin Type A) purified neurotoxin complex, formulation No. 9060X contains 100 U of Clostridium botulinum toxin Type A, 0.5 mg albumin (human), and 0.9 mg sodium chloride in a sterile, vacuum-dried form without a preservative. The study medication was to be reconstituted with 0.9% sodium chloride (preservative-free). The 10 mL of study drug was to be administered as 20 injections each of 0.5 mL. Under direct cystoscopic visualization, injections were to be distributed evenly across the detrusor wall and spaced approximately 1 cm apart. To avoid injecting the trigone, the injections were to be at least 1 cm above the trigone. The injection needle was to be inserted approximately 2 mm into the detrusor for each injection.

Interventions

BOTOX®

Each vial of BOTOX (Botulinum Toxin Type A) purified neurotoxin complex, formulation No. 9060X contains 100 U of Clostridium botulinum toxin Type A, 0.5 mg albumin (human), and 0.9 mg sodium chloride in a sterile, vacuum-dried form without a preservative. The study medication was to be reconstituted with 0.9% sodium chloride (preservative-free). The 10 mL of study drug was to be administered as 20 injections each of 0.5 mL. Under direct cystoscopic visualization, injections were to be distributed evenly across the detrusor wall and spaced approximately 1 cm apart. To avoid injecting the trigone, the injections were to be at least 1 cm above the trigone. The injection needle was to be inserted approximately 2 mm into the detrusor for each injection.

Intervention Type: BIOLOGICAL

Other Intervention Names

Botulinum Toxin Type A

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allergan

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ALLERGAN INC.

Role: STUDY_DIRECTOR

Allergan

Locations

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

Napoli, , Italy

Radboud Universitair Medisch Centrum /ID# 237043

Nijmegen, Gelderland, Netherlands

Maastricht Universitair Medisch Centrum /ID# 237678

Maastricht, , Netherlands

Oslo University Hospital /ID# 234434

Oslo, , Norway

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu /ID# 238166

Wroclaw, Lower Silesian Voivodeship, Poland

Specjalistyczny Gabinet Lekarski /ID# 235257

Poznan, , Poland

Medical Concierge Centrum Medyczne /ID# 235200

Warsaw, , Poland

St Georges Hospital /ID# 235316

Port Elizabeth, , South Africa

Manchester University NHS Foundation Trust /ID# 234380

Manchester, Lancashire, United Kingdom

Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 234819

Norwich, Norfolk, United Kingdom

NHS Greater Glasgow and Clyde /ID# 237430

Glasgow, Scotland, United Kingdom

NHS Grampian /ID# 237379

Aberdeen, , United Kingdom

Alder Hey Children's NHS Foundation Trust /ID# 237279

Liverpool, , United Kingdom

Royal Berkshire NHS Foundation Trust /ID# 236915

Reading, , United Kingdom

Sheffield Children's NHS Foundation Trust /ID# 237854

Sheffield, , United Kingdom

Countries

United States; Australia; Belgium; Canada; Czechia; France; Germany; Italy; Netherlands; Norway; Poland; South Africa; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://www.allerganclinicaltrials.com

Additional information on study locations near you may be found at AllerganClinicalTrials.com.,To be considered as a site for current and future Allergan Clinical Trials, please register using the Investigator Databank link.

Other Identifiers

2014-000464-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

191622-137

Identifier Type: -

Identifier Source: org_study_id