Dysport® Treatment of Urinary Incontinence in Adults Subjects With Neurogenic Detrusor Overactivity (NDO) Due to Spinal Cord Injury or Multiple Sclerosis - Study 1

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

Phase

3

Condition

Urinary Incontinence

Multiple Sclerosis

Spinal Cord Injuries

Treatment

N/A

Clinical Study ID

NCT02660138
D-FR-52120-222
2015-003471-30
  • 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® (AbobotulinumtoxinA) 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: 227
Study Start date:
March 01, 2016
Estimated Completion Date:
February 14, 2019

Connect with a study center

  • Jonathan Giddens Medicine Professional Corp.

    Brampton, L6T 4S5
    Canada

    Site Not Available

  • Jewish General Hospital

    Montreal, H3T IE2
    Canada

    Site Not Available

  • The Fe/Male Health Centre

    Oakville, L6H 3P1
    Canada

    Site Not Available

  • The Ottawa Hospital, Civic Campus

    Ottawa, K1Y 4E9
    Canada

    Site Not Available

  • Diex Recherche

    Québec City, G1M2S8
    Canada

    Site Not Available

  • CHUS - Hôpital Fleurimont

    Sherbrooke, 02114-2621
    Canada

    Site Not Available

  • Sunnybrook Health Sciences Centre

    Toronto, 02115-6110
    Canada

    Site Not Available

  • UBC Hospital - Koerner Pavilion

    Vancouver, V6T 2B5
    Canada

    Site Not Available

  • Spinal Cord Research Centre, University of Manitoba

    Winnipeg, R3A 1M4
    Canada

    Site Not Available

  • Fakultní Nemocnice Hradec Králové

    Hradec Králové, 500 05
    Czech Republic

    Site Not Available

  • Agora Flora

    Praha 3, 13000
    Czech Republic

    Site Not Available

  • Fakultní Nemocnice Brno

    Brno, 62500
    Czechia

    Site Not Available

  • Karlovarska krajska nemocnice, a.s.

    Karlovy Vary, 360 01
    Czechia

    Site Not Available

  • Krajská Nemocnice Liberec, a.s.

    Liberec, 46063
    Czechia

    Site Not Available

  • Uromedical Center s.r.o.

    Olomouc, 77900
    Czechia

    Site Not Available

  • Thomayerova nemocnice

    Praha, 14059
    Czechia

    Site Not Available

  • Fakultní nemocnice Královské Vinohrady

    Praha 10, 100 34
    Czechia

    Site Not Available

  • Všeobecná fakultní nemocnice v Praze

    Praha 2, 12808
    Czechia

    Site Not Available

  • Fakultní Nemocnice v Motole

    Praha 5, 15006
    Czechia

    Site Not Available

  • Urologicka Ordinace s.r.o.

    Sternberk, 785 01
    Czechia

    Site Not Available

  • Azienda Ospedaliero-Universitaria Careggi - Dipartimento Di Neuro-Urologia

    Firenze, 50134
    Italy

    Site Not Available

  • Farmacia Istituto Ospedaliero ICOT "Marco Pasquali"

    Latina, 04100
    Italy

    Site Not Available

  • Ospedale San Raffaele - UO Di Urologia

    Milano, 20132
    Italy

    Site Not Available

  • Azienda Ospedaliera di Perugia - Ospedale Santa Maria della Misericordia

    Perugia, 06132
    Italy

    Site Not Available

  • Viale Oxford, 81

    Roma, 00133
    Italy

    Site Not Available

  • Ospedale "Bolognini" di Seriate

    Seriate, 24068
    Italy

    Site Not Available

  • Ospedale Di Treviglio - DIP Di Neuro-Urologia E Urodinamica

    Treviglio, 24047
    Italy

    Site Not Available

  • Ospedale Di Treviglio - DIP Di Neuro-Urologia E Urodinamica

    Treviglio (Bergamo), 24047
    Italy

    Site Not Available

  • Pia Fondazione Di Culto E Di Religione Cardinal G. Panico

    Tricase, 73039
    Italy

    Site Not Available

  • Pia Fondazione Di Culto E Di Religione Cardinal G. Panico

    Tricase (Lecce), 73039
    Italy

    Site Not Available

  • Azienda Ospedaliera di Perugia - Ospedale Santa Maria della Misericordia

    Udine, 33100
    Italy

    Site Not Available

  • 88 Olympic-ro 43-gil, Songpa-gu

    Seoul, 05505
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul, 6351
    Korea, Republic of

    Site Not Available

  • Ulsan University Hospital (UUH)

    Ulsan, 44033
    Korea, Republic of

    Site Not Available

  • Jalan Yaacob Latiff, Bandar Tun Razak

    Kuala Lumpur, 56000
    Malaysia

    Site Not Available

  • VU University Medical Center

    Amsterdam, 1081 HV
    Netherlands

    Site Not Available

  • Radboud UMC

    Nijmegen, 6525 GA
    Netherlands

    Site Not Available

  • Erasmus MC

    Rotterdam, 3015 CE
    Netherlands

    Site Not Available

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3584 CX
    Netherlands

    Site Not Available

  • Wojewódzki Szpital Zespolony w Elblągu

    Elblag, 82-300
    Poland

    Site Not Available

  • Nzoz Neuro-Medic Poradnia Wielospecjalistyczna

    Katowice, 40-752
    Poland

    Site Not Available

  • Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

    Lublin, 20-954
    Poland

    Site Not Available

  • NZOZ Heureka

    Piaseczno, 05-500
    Poland

    Site Not Available

  • Kliniczny Szpital Wojewódzki Nr 1 im. Fryderyka Chopina w Rzeszowie

    Rzeszow, 35-055
    Poland

    Site Not Available

  • Szpital Kliniczny Dzieciątka Jezus w Warszawie

    Warszawa, 02-005
    Poland

    Site Not Available

  • EuroMediCare Szpital Specjalistyczny z Przychodnią we Wrocławiu

    Wroclaw, 54-144
    Poland

    Site Not Available

  • Hospital de Braga

    Braga, 4700-001
    Portugal

    Site Not Available

  • Centro Hospitalar e Universitário de Coimbra, EPE - Hospitais da Universidade de Coimbra

    Coimbra, 3000-075
    Portugal

    Site Not Available

  • Centro Hospitalar do Alto Ave, EPE

    Guimarães, 4835-044
    Portugal

    Site Not Available

  • British Hospital

    Lisboa, 1600-209
    Portugal

    Site Not Available

  • Centro Hospitalar de São João, EPE - Hospital de São João

    Porto, 4200-319
    Portugal

    Site Not Available

  • Centro Hospitalar do Porto, EPE - Hospital Geral de Santo António

    Porto, 4099-001
    Portugal

    Site Not Available

  • Gnosis Evomed

    Bucharest, 031864
    Romania

    Site Not Available

  • Hifu Terramed Conformal S.R.L

    Bucharest, 31864
    Romania

    Site Not Available

  • Spitalul Clinic Colentina

    Bucharest, 20125
    Romania

    Site Not Available

  • Spitalul Clinic Fundeni Bucureşti

    Bucharest, 22328
    Romania

    Site Not Available

  • Spitalul Clinic Judeţean Mureş

    Târgu-Mureş, 540103
    Romania

    Site Not Available

  • Ankara Üniversitesi Tıp Fakültesi

    Ankara, 6100
    Turkey

    Site Not Available

  • Medipol Mega University Hospital

    Bagcilar, 34200
    Turkey

    Site Not Available

  • Uludag Universitesi Tip Fakultesi, Uroloji Anabilim Dali, Gorukle

    Bursa, 16059
    Turkey

    Site Not Available

  • Istanbul Medeniyet Universitesi Goztepe Egitim ve Arastirma Hastanesi Merdivenköy Mah

    Istanbul, 34732
    Turkey

    Site Not Available

  • Marmara Üniversitesi Eğitim ve Araştırma Hastanesi

    Istanbul, 34670
    Turkey

    Site Not Available

  • Erciyes Üniversitesi Tıp Fakültesi

    Kayseri, 38039
    Turkey

    Site Not Available

  • Kocaeli Üniversitesi Tıp Fakültesi

    Kocaeli, 41380
    Turkey

    Site Not Available

  • Celal Bayar Universitesi Hafsa Sultan Hastanesi

    Manisa, 45040
    Turkey

    Site Not Available

  • Ondokuz Mayıs Üniversitesi Tıp Fakültesi

    Samsun, 55139
    Turkey

    Site Not Available

  • UAB School of Medicine Spain Rehabilitation Center (SRC)

    Birmingham, Alabama 35249
    United States

    Site Not Available

  • Urological Associates of Southern Arizona, P.C.

    Tucson, Arizona 85715-3808
    United States

    Site Not Available

  • Applied Research Center of Arkansas

    Little Rock, Arkansas 72212
    United States

    Site Not Available

  • Orange County Urology Associates

    Laguna Hills, California 92653
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Laguna Woods, California 92637
    United States

    Site Not Available

  • Atlantic Urology Medical Group

    Long Beach, California 90806
    United States

    Site Not Available

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California 90089
    United States

    Site Not Available

  • VA Palo Alto Health Care System

    Palo Alto, California 94304
    United States

    Site Not Available

  • UC Davis Medical Center

    Sacramento, California 95817-2307
    United States

    Site Not Available

  • University of Colorado Denver

    Aurora, Colorado 80045-2527
    United States

    Site Not Available

  • Women's Health Specialty Care

    Farmington, Connecticut 06032-1933
    United States

    Site Not Available

  • Gousse Urology - The Bladder Heath and Reconstructive Urology Institute

    Miramar, Florida 33029-5593
    United States

    Site Not Available

  • Idaho Urologic Institute

    Meridian, Idaho 83642-6245
    United States

    Site Not Available

  • The Iowa Clinic, PC

    West Des Moines, Iowa 50266
    United States

    Site Not Available

  • Regional Urology, LLC

    Shreveport, Louisiana 71106
    United States

    Site Not Available

  • MidAtlantic Urology Associates, LLC

    Greenbelt, Maryland 20770
    United States

    Site Not Available

  • Chesapeake Urology Associates, PA

    Owings Mills, Maryland 21117
    United States

    Site Not Available

  • University of Michigan Hospital

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Metro Urology (Woodbury)

    Woodbury, Minnesota 55125
    United States

    Site Not Available

  • Weill Cornell Medical College

    Denville, New Jersey 07834
    United States

    Site Not Available

  • Premier Urology Group

    Edison, New Jersey 08837-2429
    United States

    Site Not Available

  • Delaware Valley Urology,IIC

    Voorhees, New Jersey 08043
    United States

    Site Not Available

  • Urology Group of New Mexico, PC

    Albuquerque, New Mexico 87109
    United States

    Site Not Available

  • Montefiore Medical Center

    Bronx, New York 10461
    United States

    Site Not Available

  • New York University Langone Medical Center and School of Medicine

    New York, New York 10016
    United States

    Site Not Available

  • New York-Presbyterian Hospital/Weill Cornell Medical Center

    New York, New York 10065
    United States

    Site Not Available

  • Advanced Urology Centers of New York

    Plainview, New York 11783
    United States

    Site Not Available

  • Montefiore Medical Center

    The Bronx, New York 10461
    United States

    Site Not Available

  • University of North Carolina School of Medicine

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • Levine Cancer Institute

    Charlotte, North Carolina 28207
    United States

    Site Not Available

  • Alliance Urology Specialists

    Greensboro, North Carolina 27403
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Louis Stokes Cleveland Veterans Affairs Medical Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Lancaster Urology

    Lancaster, Pennsylvania 17601
    United States

    Site Not Available

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Medical University of South Carolina (MUSC)

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Carolina Urologic Research Center, LLC

    Myrtle Beach, South Carolina 29572-4607
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Urology Clinics of North Texas

    Dallas, Texas 75231
    United States

    Site Not Available

  • Houston Methodist Hospital

    Houston, Texas 77030
    United States

    Site Not Available

  • Lahey Hospital & Medical Center

    Burlington, Vermont 01805-0001
    United States

    Site Not Available

  • Urology of Virginia, PLLC

    Virginia Beach, Virginia 23462-1815
    United States

    Site Not Available

  • Integrity Medical Research

    Mountlake Terrace, Washington 98043
    United States

    Site Not Available

  • Zain Research

    Richland, Washington 99352-4853
    United States

    Site Not Available

  • Medical College of Wisconsin - Freodert Hospital

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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