56
Participants
Start Date
May 23, 2014
Primary Completion Date
February 10, 2022
Study Completion Date
February 10, 2022
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.
Sydney Children's Hospital /ID# 237191, Randwick
The Children's Hospital at Westmead /ID# 234337, Sydney
Universitair Ziekenhuis Antwerpen /ID# 237997, Edegem
Universitair Ziekenhuis Leuven /ID# 237218, Leuven
Monash Children's Hospital /ID# 234388, Clayton
St Georges Hospital /ID# 235316, Port Elizabeth
UZ Gent /ID# 237588, Ghent
Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 234288, Lübeck
Associated Urologist of North Carolina /ID# 235437, Raleigh
Orlando Health-Arnold Palmer Hospital for Children Pediatric Urology /ID# 235283, Orlando
Duplicate_CHU Bordeaux-Hopital Pellegrin /ID# 237392, Bordeaux
Evangelisches Krankenhaus Bielefeld /ID# 235234, Bielefeld
Children's Hospital Wisconsin - Milwaukee Campus /ID# 237544, Milwaukee
Arkansas Children's Hospital /ID# 237787, Little Rock
Cook Children's Med. Center /ID# 237539, Fort Worth
Urologische Gemeinschaftspraxis /ID# 234978, Emmendingen
Children's Hospital Colorado /ID# 237621, Aurora
AOU Universita degli Studi della Campania Luigi Vanvitelli /ID# 237308, Napoli
Hôpital de la Mère et de l'Enfant /ID# 235227, Limoges
Alaska Urological Institute /ID# 238189, Anchorage
Yale New Haven Hospital - Yale School of Medicine /ID# 238222, New Haven
Alberta Children's Hospital /ID# 237510, Calgary
London Health Sciences Center /ID# 234304, London
CHUS - Hopital Fleurimont /ID# 237668, Sherbrooke
Fakultni nemocnice Olomouc /ID# 237577, Olomouc
Hôpitaux Pédiatriques de Nice CHU-LENVAL /ID# 235278, Nice
Radboud Universitair Medisch Centrum /ID# 237043, Nijmegen
Maastricht Universitair Medisch Centrum /ID# 237678, Maastricht
Oslo University Hospital /ID# 234434, Oslo
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu /ID# 238166, Wroclaw
Specjalistyczny Gabinet Lekarski /ID# 235257, Poznan
Medical Concierge Centrum Medyczne /ID# 235200, Warsaw
Manchester University NHS Foundation Trust /ID# 234380, Manchester
Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 234819, Norwich
NHS Greater Glasgow and Clyde /ID# 237430, Glasgow
NHS Grampian /ID# 237379, Aberdeen
Alder Hey Children's NHS Foundation Trust /ID# 237279, Liverpool
Royal Berkshire NHS Foundation Trust /ID# 236915, Reading
Sheffield Children's NHS Foundation Trust /ID# 237854, Sheffield
Lead Sponsor
Allergan
INDUSTRY