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

Last updated: September 15, 2022
Sponsor: Ipsen
Overall Status: Terminated

Phase

3

Condition

Overactive Bladder

Memory Loss

Urinary Incontinence

Treatment

N/A

Clinical Study ID

NCT02660359
D-FR-52120-223
2015-000507-44
  • Ages 18-80
  • All Genders

Study Summary

The purpose of this study is to provide confirmatory evidence of the safety and efficacy of two Dysport® doses (600 units [U] and 800 U), compared to placebo in reducing urinary incontinence (UI) in adult subjects treated for neurogenic detrusor overactivity (NDO) due to spinal cord injury (SCI) or multiple sclerosis (MS).

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Urinary Incontinence for at least 3 months prior to Screening as a result ofNeurogenic Detrusor Overactivity due to Spinal Cord Injury or Multiple Sclerosis.
  • Subjects with Spinal Cord Injury must have a stable neurological injury at T1 level orbelow which occurred at least 6 months prior to Screening.
  • Subjects with Multiple Sclerosis must be clinically stable in the investigator'sopinion, with no exacerbation (relapse) of MS for at least 3 months prior toScreening.
  • Subjects must have had an inadequate response after at least 4 weeks of oralmedications used in the treatment of NDO (e.g. anticholinergics, beta-3 agonists)and/or have intolerable side-effects.
  • Routinely performing Clean Intermittent Catheterization (CIC) to ensure adequatebladder emptying.
  • An average of at least two episodes per day of Urinary Incontinence recorded on thescreening bladder diary.

Exclusion

Key Exclusion Criteria:

  • Any current condition (other than NDO) that may impact on bladder function.
  • Previous or current, tumour or malignancy affecting the spinal column or spinal cord,or any other unstable cause of SCI.
  • Any condition that will prevent cystoscopic treatment administration or CIC usage,e.g. urethral strictures.
  • Current indwelling bladder catheter, or removal of indwelling bladder catheter lessthan 4 weeks prior to Screening.
  • BTX-A treatment within 9 months prior to Screening for any urological condition (e.g.detrusor or urethral sphincter treatments).
  • Any neuromodulation/electrostimulation usage for urinary symptoms/incontinence within 4 weeks prior to Screening. Any implanted neuromodulation device must be switched offat least 4 weeks prior to Screening.

Study Design

Total Participants: 258
Study Start date:
July 08, 2016
Estimated Completion Date:
July 04, 2019

Connect with a study center

  • Centro de Urologia

    Buenos Aires, C1120AAS
    Argentina

    Site Not Available

  • Instituto Urológico Buenos Aires

    Buenos Aires, 1060
    Argentina

    Site Not Available

  • Centro Urológico Profesor Bengió

    Córdoba, X5000
    Argentina

    Site Not Available

  • Hospital Privado - Centro Médico de Córdoba

    Córdoba, X5016KEH
    Argentina

    Site Not Available

  • Instituto Médico Rodriguez Alfici

    Godoy Cruz, M5501AAP
    Argentina

    Site Not Available

  • Repatriation General Hospital

    Daw Park, 5041
    Australia

    Site Not Available

  • Western Hospital

    Footscray, 3011
    Australia

    Site Not Available

  • Fiona Stanley Hospital

    Murdoch, 6150
    Australia

    Site Not Available

  • Prince of Wales Hospital (POWH)

    Sydney, 2031
    Australia

    Site Not Available

  • Westmead Hospital

    Westmead, 2145
    Australia

    Site Not Available

  • Antwerp University hospital

    Antwerp,
    Belgium

    Site Not Available

  • Hôpital Erasme

    Brussels, 1070
    Belgium

    Site Not Available

  • Ourthe-Amblève

    Esneux, 4130
    Belgium

    Site Not Available

  • CHU de Liège - Site du Sart Tilman

    Liège, 4000
    Belgium

    Site Not Available

  • Hospital Universitário São José

    Belo Horizonte, 30140-073
    Brazil

    Site Not Available

  • Universidade Estadual de Campinas - Cidade Universitária Zeferino Vaz

    Campinas, 13083-970
    Brazil

    Site Not Available

  • Hospital de Clinicas, Federal University of Paraná

    Curitiba, 80060-900
    Brazil

    Site Not Available

  • Hospital e Maternidade Teresinha de Jesus

    Juiz de Fora, 36025-330
    Brazil

    Site Not Available

  • Hospital São Vicente de Paulo

    Passo Fundo, 99010-080
    Brazil

    Site Not Available

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

    Porto Alegre, 90020-090
    Brazil

    Site Not Available

  • Hospital Moinhos de Vento

    Pôrto Alegre, 90560-030
    Brazil

    Site Not Available

  • Hospital São Lucas da PUCRS

    Pôrto Alegre, 90610-000
    Brazil

    Site Not Available

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

    Ribeirao Preto, 14048-900
    Brazil

    Site Not Available

  • Faculdade de Medicina do ABC

    Santo André, 09060-650
    Brazil

    Site Not Available

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

    Sao Paulo, 05422-970
    Brazil

    Site Not Available

  • Hospital Alemão Oswaldo Cruz

    São Paulo, 01323-020
    Brazil

    Site Not Available

  • Clinica INDISA

    Providencia, 7520279
    Chile

    Site Not Available

  • Clínica Las Condes

    Santiago, 7591046
    Chile

    Site Not Available

  • Clínica Uromed

    Santiago, 7500787
    Chile

    Site Not Available

  • Hospital del Trabajador

    Santiago, 7501241
    Chile

    Site Not Available

  • Centro De Investigacion Clinica Del Sur, LTDA.

    Temuco, 4781156
    Chile

    Site Not Available

  • Fundación Cardio Infantil - Instituto de Cardiología

    Bogota, 110131
    Colombia

    Site Not Available

  • MedPlus Medicina Prepagada S.A

    Bogota D.C, 110221
    Colombia

    Site Not Available

  • Solano & Terront Servicios Medicos LTDA- Unidad Integral de Endocrinologia

    Bogotá, 110221
    Colombia

    Site Not Available

  • Centro Medico Imbanaco

    Cali, 760042
    Colombia

    Site Not Available

  • Fundación Valle del Lili

    Cali, 760032
    Colombia

    Site Not Available

  • Asociacion IPS Medicos Internistas de Caldas

    Manizales, 170004
    Colombia

    Site Not Available

  • Centro de Investigaciones Clinicas - CIC

    Medellin, 5001000
    Colombia

    Site Not Available

  • CHU Hopitaux de Bordeaux - Groupe Hospitalier Pellegrin

    Bordeaux,
    France

    Site Not Available

  • CHU Dijon - Hopital du Bocage

    Dijon Cedex,
    France

    Site Not Available

  • Hôpital Raymond-Poincaré

    Garches,
    France

    Site Not Available

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

    Lille Cedex,
    France

    Site Not Available

  • Hôpital de la Conception

    Marseille CEDEX 5,
    France

    Site Not Available

  • Groupe Hospitalo-Universitaire Pierre Caremau

    Nimes Cedex 9,
    France

    Site Not Available

  • Hopital de la Source

    Orleans,
    France

    Site Not Available

  • Hopital Pitie-Salpetriere

    Paris,
    France

    Site Not Available

  • Hôpital Tenon

    Paris Cedex 20,
    France

    Site Not Available

  • Centre Hospitalier Lyon-Sud

    Pierre-Bénite,
    France

    Site Not Available

  • CHU de Rennes - Hôpital Pontchaillou

    Rennes,
    France

    Site Not Available

  • CHU de ROUEN - Hôpital Charles Nicolle

    Rouen Cedex,
    France

    Site Not Available

  • Hôpital Rangueil

    Toulouse Cedex 9,
    France

    Site Not Available

  • Universitätsklinikum Aachen

    Aachen, 5207
    Germany

    Site Not Available

  • Universitätsklinikum Bonn Klinik und Poliklinik für Urologie

    Bonn, 53127
    Germany

    Site Not Available

  • Kliniken Maria Hilf GmbH - Krankenhaus St. Franziskus

    Monchengladbach,
    Germany

    Site Not Available

  • Universitätsklinikum Bonn

    Muehlacker,
    Germany

    Site Not Available

  • Universitätsklinikum Münster

    Mönchengladbach,
    Germany

    Site Not Available

  • Universitätsklinikum Münster

    Münster, 48149
    Germany

    Site Not Available

  • Carmel Medical Center

    Haifa, 34362
    Israel

    Site Not Available

  • Rambam Medical Center

    Haifa, 31096
    Israel

    Site Not Available

  • Meir Medical Center

    Kfar Saba, 44281
    Israel

    Site Not Available

  • Rabin Medical Center - Davidoff Center

    Petah Tikva, 49100
    Israel

    Site Not Available

  • The Chaim Sheba Medical Center

    Ramat Gan, 52621
    Israel

    Site Not Available

  • Estetines Chirurgijos Centas, UAB

    Kaunas, 49476
    Lithuania

    Site Not Available

  • Vilnius University Hospital Santariskiu Klinikos

    Vilnius, 8661
    Lithuania

    Site Not Available

  • Centro Medico Puerta de Hierro - Colima

    Colima, 28018
    Mexico

    Site Not Available

  • Clinstile, S.A. de C.V.

    Cuauhtémoc, 06700
    Mexico

    Site Not Available

  • UMAE Hospital de Especialidades Centro Medico Nacional Siglo XXI

    Mexico City, _06720
    Mexico

    Site Not Available

  • Clinstile, S.A. de C.V.

    Mexico D.F., _06700
    Mexico

    Site Not Available

  • Hospital Universitario "Dr. José Eleuterio González"

    Monterrey, 64460
    Mexico

    Site Not Available

  • Consultorio Privado

    Zapopan, 45040
    Mexico

    Site Not Available

  • Canterbury Urology Research Trust

    Christchurch,
    New Zealand

    Site Not Available

  • Tauranga Urology Research Ltd.

    Tauranga,
    New Zealand

    Site Not Available

  • Clinica Good Hope

    Lima, Lima18
    Peru

    Site Not Available

  • Clinica Internacional Sede Lima

    Lima, Lima1
    Peru

    Site Not Available

  • Clínica Anglo Americana

    Lima, Lima27
    Peru

    Site Not Available

  • Clínica San Pablo Surco

    Lima, 15023
    Peru

    Site Not Available

  • Instituto de Ginecología y Reproducción

    Lima, Lima33
    Peru

    Site Not Available

  • Unidad de Investigación de la Clínica Internacional Sede San Borja

    Lima, Lima41
    Peru

    Site Not Available

  • Ministry of healthcare of the Russian Federation

    Moscow, 129226
    Russian Federation

    Site Not Available

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

    Moscow, 105425
    Russian Federation

    Site Not Available

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

    Penza, 440026
    Russian Federation

    Site Not Available

  • Rostov State Medical University

    Rostov-on-Don, 344022
    Russian Federation

    Site Not Available

  • City Hospital No. 40

    Saint Petersburg, 197706
    Russian Federation

    Site Not Available

  • Hospital Orkli

    Saint Petersburg,
    Russian Federation

    Site Not Available

  • Pavlov First Saint Petersburg State Medical University

    Saint Petersburg, 197089
    Russian Federation

    Site Not Available

  • St. Petersburg Research Institute of Phthisiopulmonology

    Saint Petersburg, 194064
    Russian Federation

    Site Not Available

  • Complexo Hospitalario Universitario A Coruña

    A Coruña,
    Spain

    Site Not Available

  • Sanitas La Zarzuela Hospital

    Aravaca,
    Spain

    Site Not Available

  • Fundacio Puigvert

    Barcelona, 08025
    Spain

    Site Not Available

  • Fundació GAEM

    Barcelona,
    Spain

    Site Not Available

  • Hospital Universitario Vall d'Hebron

    Barcelona,
    Spain

    Site Not Available

  • Hospital Universitario De Canarias

    La Laguna,
    Spain

    Site Not Available

  • Hospital Universitario La Paz

    Madrid,
    Spain

    Site Not Available

  • Hospital Universitario Infanta Sofía

    San Sebastián de Los Reyes,
    Spain

    Site Not Available

  • Hospital Universitario Virgen del Rocío

    Sevilla,
    Spain

    Site Not Available

  • Hospital Universitari i Politècnic La Fe

    Valencia,
    Spain

    Site Not Available

  • Regional Public Institution "Chernivtsi Regional Clinical Hospital", Urology Department

    Chernivtsi, 58001
    Ukraine

    Site Not Available

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

    Kharkiv, 61037
    Ukraine

    Site Not Available

  • Kiev City Clinical Hospital No. 3

    Kiev, 02125
    Ukraine

    Site Not Available

  • MUNICIPAL INSTITUTION "ZAPORIZHZHIA STATE CLINICAL HOSPITAL" OF ZAPORIZHZHIA REGIONAL council

    Zaporozh'ye, 69600
    Ukraine

    Site Not Available

  • NHS Grampian - Aberdeen Royal Infirmary

    Aberdeen, AB25 2ZN
    United Kingdom

    Site Not Available

  • Bedford Hospital

    Bedford, MK42 9DJ
    United Kingdom

    Site Not Available

  • North Bristol NHS Trust - Southmead Hospital Bristol

    Bristol, BS10 5NB
    United Kingdom

    Site Not Available

  • Colchester Hospital University NHS Foundation Trust - Colchester General Hospital

    Colchester, CO4 5JL
    United Kingdom

    Site Not Available

  • National Hospital for Neurology and Neurosurgery - UCL

    London, WC1N 3BG
    United Kingdom

    Site Not Available

  • South Tees Hospitals NHS Foundation Trust - The James Cook University Hospital

    Middlesbrough, TS4 3BW
    United Kingdom

    Site Not Available

  • Sheffield Teaching Hospitals NHS Foundation Trust - Royal Hallamshire Hospital

    Sheffield, S10 2JF
    United Kingdom

    Site Not Available

  • Royal National Orthopaedic Hospital Trust

    Stanmore, HA7 4LP
    United Kingdom

    Site Not Available

  • The Mid Yorkshire Hospitals NHS Trust - Pinderfields Hospital

    Wakefield, WF1 4DG
    United Kingdom

    Site Not Available

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