Dysport® Treatment of Urinary Incontinence in Adults Subjects With Neurogenic Detrusor Overactivity (NDO) Due to Spinal Cord Injury or Multiple Sclerosis - Study 2

PHASE3TerminatedINTERVENTIONAL
Enrollment

258

Participants

Timeline

Start Date

July 8, 2016

Primary Completion Date

November 9, 2018

Study Completion Date

July 4, 2019

Conditions
Urinary IncontinenceOveractive Bladder
Interventions
BIOLOGICAL

Botulinum toxin type A

600 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points.

BIOLOGICAL

Botulinum toxin type A

800 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points

DRUG

Placebo

AbobotulinumtoxinA Placebo 600 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points

DRUG

Placebo

AbobotulinumtoxinA Placebo 800 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points

Trial Locations (82)

1060

Instituto Urológico Buenos Aires, Buenos Aires

1070

Hôpital Erasme, Brussels

2031

Prince of Wales Hospital (POWH), Sydney

2145

Westmead Hospital, Westmead

4130

Ourthe-Amblève, Esneux

8661

Vilnius University Hospital Santariskiu Klinikos, Vilnius

15023

Clínica San Pablo Surco, Lima

28018

Centro Medico Puerta de Hierro - Colima, Colima

31096

Rambam Medical Center, Haifa

34362

Carmel Medical Center, Haifa

44281

Meir Medical Center, Kfar Saba

45040

Consultorio Privado, Zapopan

48149

Universitätsklinikum Münster, Münster

49100

Rabin Medical Center - Davidoff Center, Petah Tikva

49476

Estetines Chirurgijos Centas, UAB, Kaunas

52621

The Chaim Sheba Medical Center, Ramat Gan

53127

Universitätsklinikum Bonn Klinik und Poliklinik für Urologie, Bonn

61037

"Municipal Healthcare Institution Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval, Urology Department", Kharkiv

64460

"Hospital Universitario Dr. José Eleuterio González", Monterrey

105425

Scientific research institute of urology and interventional radiology n. a. N. A. Lopatkin, Moscow

110221

Solano & Terront Servicios Medicos LTDA- Unidad Integral de Endocrinologia, Bogotá

129226

Ministry of healthcare of the Russian Federation, Moscow

170004

Asociacion IPS Medicos Internistas de Caldas, Manizales

194064

St. Petersburg Research Institute of Phthisiopulmonology, Saint Petersburg

197089

Pavlov First Saint Petersburg State Medical University, Saint Petersburg

197706

City Hospital No. 40, Saint Petersburg

344022

Rostov State Medical University, Rostov-on-Don

440026

Penza Regional Clinical Hospital n.a. N.N.Burdenko, Penza

760032

Fundación Valle del Lili, Santiago de Cali

760042

Centro Medico Imbanaco, Santiago de Cali

5001000

Centro de Investigaciones Clinicas - CIC, Medellín

7500787

Clínica Uromed, Santiago

7501241

Hospital del Trabajador, Santiago

7591046

Clínica Las Condes, Santiago

C1120AAS

Centro de Urologia, Buenos Aires

X5000

Centro Urológico Profesor Bengió, Córdoba

X5016KEH

Hospital Privado - Centro Médico de Córdoba, Córdoba

M5501AAP

Instituto Médico Rodriguez Alfici, Godoy Cruz

Unknown

Antwerp University hospital, Antwerp

Hôpital Raymond-Poincaré, Garches

Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez, Lille

Hôpital de la Conception, Marseille

Groupe Hospitalo-Universitaire Pierre Caremau, Nîmes

Hopital de la Source, Orléans

Hopital Pitie-Salpetriere, Paris

Hôpital Tenon, Paris

Centre Hospitalier Lyon-Sud, Pierre-Bénite

CHU de Rennes - Hôpital Pontchaillou, Rennes

CHU de ROUEN - Hôpital Charles Nicolle, Rouen

Hôpital Rangueil, Toulouse

Kliniken Maria Hilf GmbH - Krankenhaus St. Franziskus, Mönchengladbach

Hospital Orkli, Saint Petersburg

Complexo Hospitalario Universitario A Coruña, A Coruña

Fundació GAEM, Barcelona

Hospital Universitario Vall d'Hebron, Barcelona

Hospital Universitario La Paz, Madrid

Hospital Universitario Virgen del Rocío, Seville

Hospital Universitari i Politècnic La Fe, Valencia

13083-970

Universidade Estadual de Campinas - Cidade Universitária Zeferino Vaz, Campinas

80060-900

Hospital de Clinicas, Federal University of Paraná, Curitiba

99010-080

Hospital São Vicente de Paulo, Passo Fundo

90020-090

Santa Casa de Misericórdia de Porto Alegre - Hospital Santa Clara, Porto Alegre

90560-030

Hospital Moinhos de Vento, Pôrto Alegre

90610-000

Hospital São Lucas da PUCRS, Pôrto Alegre

14048-900

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo, Ribeirão Preto

09060-650

Faculdade de Medicina do ABC, Santo André

01323-020

Hospital Alemão Oswaldo Cruz, São Paulo

05422-970

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo

06700

Clinstile, S.A. de C.V., Cuauhtémoc

Lima18

Clinica Good Hope, Lima

Lima1

Clinica Internacional Sede Lima, Lima

Lima27

Clínica Anglo Americana, Lima

Lima33

Instituto de Ginecología y Reproducción, Lima

Lima41

Unidad de Investigación de la Clínica Internacional Sede San Borja, Lima

08025

Fundacio Puigvert, Barcelona

02125

Kiev City Clinical Hospital No. 3, Kiev

AB25 2ZN

NHS Grampian - Aberdeen Royal Infirmary, Aberdeen

MK42 9DJ

Bedford Hospital, Bedford

WC1N 3BG

National Hospital for Neurology and Neurosurgery - UCL, London

S10 2JF

Sheffield Teaching Hospitals NHS Foundation Trust - Royal Hallamshire Hospital, Sheffield

HA7 4LP

Royal National Orthopaedic Hospital Trust, Stanmore

WF1 4DG

The Mid Yorkshire Hospitals NHS Trust - Pinderfields Hospital, Wakefield

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Ipsen

INDUSTRY