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

PHASE3TerminatedINTERVENTIONAL
Enrollment

227

Participants

Timeline

Start Date

March 31, 2016

Primary Completion Date

November 9, 2018

Study Completion Date

February 14, 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 (81)

6100

Ankara Üniversitesi Tıp Fakültesi, Ankara

6351

Samsung Medical Center, Seoul

10016

New York University Langone Medical Center and School of Medicine, New York

10065

New York-Presbyterian Hospital/Weill Cornell Medical Center, New York

10461

Montefiore Medical Center, The Bronx

11783

Advanced Urology Centers of New York, Plainview

12808

Všeobecná fakultní nemocnice v Praze, Prague

14059

Thomayerova nemocnice, Prague

15006

Fakultní Nemocnice v Motole, Prague

16059

Uludag Universitesi Tip Fakultesi, Uroloji Anabilim Dali, Gorukle, Bursa

17601

Lancaster Urology, Lancaster

19107

Thomas Jefferson University Hospital, Philadelphia

20125

Spitalul Clinic Colentina, Bucharest

21117

Chesapeake Urology Associates, PA, Owings Mills

22328

Spitalul Clinic Fundeni Bucureşti, Bucharest

24068

"Ospedale Bolognini di Seriate", Seriate

27599

University of North Carolina School of Medicine, Chapel Hill

28207

Levine Cancer Institute, Charlotte

29425

Medical University of South Carolina (MUSC), Charleston

31864

Hifu Terramed Conformal S.R.L, Bucharest

33100

Azienda Ospedaliera di Perugia - Ospedale Santa Maria della Misericordia, Udine

34200

Medipol Mega University Hospital, Bağcılar

34670

Marmara Üniversitesi Eğitim ve Araştırma Hastanesi, Istanbul

34732

Istanbul Medeniyet Universitesi Goztepe Egitim ve Arastirma Hastanesi Merdivenköy Mah, Istanbul

35249

UAB School of Medicine Spain Rehabilitation Center (SRC), Birmingham

37232

Vanderbilt University Medical Center, Nashville

38039

Erciyes Üniversitesi Tıp Fakültesi, Kayseri

41380

Kocaeli Üniversitesi Tıp Fakültesi, Kocaeli

44033

Ulsan University Hospital (UUH), Ulsan

44106

Louis Stokes Cleveland Veterans Affairs Medical Center, Cleveland

44195

Cleveland Clinic, Cleveland

45040

Celal Bayar Universitesi Hafsa Sultan Hastanesi, Manisa

46063

Krajská Nemocnice Liberec, a.s., Liberec

48109

University of Michigan Hospital, Ann Arbor

50134

Azienda Ospedaliero-Universitaria Careggi - Dipartimento Di Neuro-Urologia, Florence

50266

The Iowa Clinic, PC, West Des Moines

53226

Medical College of Wisconsin - Freodert Hospital, Milwaukee

55139

Ondokuz Mayıs Üniversitesi Tıp Fakültesi, Samsun

62500

Fakultní Nemocnice Brno, Brno

75231

Urology Clinics of North Texas, Dallas

77030

Houston Methodist Hospital, Houston

77900

Uromedical Center s.r.o., Olomouc

87109

Urology Group of New Mexico, PC, Albuquerque

90089

USC Norris Comprehensive Cancer Center, Los Angeles

90806

Atlantic Urology Medical Group, Long Beach

98043

Integrity Medical Research, Mountlake Terrace

540103

Spitalul Clinic Judeţean Mureş, Târgu Mureş

85715-3808

Urological Associates of Southern Arizona, P.C., Tucson

95817-2307

UC Davis Medical Center, Sacramento

80045-2527

University of Colorado Denver, Aurora

06032-1933

Women's Health Specialty Care, Farmington

33029-5593

Gousse Urology - The Bladder Heath and Reconstructive Urology Institute, Miramar

07834

Weill Cornell Medical College, Denville

08043

Delaware Valley Urology,IIC, Voorhees Township

01805-0001

Lahey Hospital & Medical Center, Burlington

23462-1815

Urology of Virginia, PLLC, Virginia Beach

02114-2621

CHUS - Hôpital Fleurimont, Sherbrooke

02115-6110

Sunnybrook Health Sciences Centre, Toronto

V6T 2B5

UBC Hospital - Koerner Pavilion, Vancouver

R3A 1M4

Spinal Cord Research Centre, University of Manitoba, Winnipeg

360 01

Karlovarska krajska nemocnice, a.s., Karlovy Vary

100 34

Fakultní nemocnice Královské Vinohrady, Prague

785 01

Urologicka Ordinace s.r.o., Sternberk

04100

"Farmacia Istituto Ospedaliero ICOT Marco Pasquali", Latina

06132

Azienda Ospedaliera di Perugia - Ospedale Santa Maria della Misericordia, Perugia

00133

Viale Oxford, 81, Roma

1081 HV

VU University Medical Center, Amsterdam

6525 GA

Radboud UMC, Nijmegen

3015 CE

Erasmus MC, Rotterdam

82-300

Wojewódzki Szpital Zespolony w Elblągu, Elblag

40-752

Nzoz Neuro-Medic Poradnia Wielospecjalistyczna, Katowice

05-500

NZOZ Heureka, Piaseczno

02-005

Szpital Kliniczny Dzieciątka Jezus w Warszawie, Warsaw

54-144

EuroMediCare Szpital Specjalistyczny z Przychodnią we Wrocławiu, Wroclaw

4700-001

Hospital de Braga, Braga

4835-044

Centro Hospitalar do Alto Ave, EPE, Guimarães

1600-209

British Hospital, Lisbon

4099-001

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

4200-319

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

031864

Gnosis Evomed, Bucharest

05505

88 Olympic-ro 43-gil, Songpa-gu, Seoul

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Ipsen

INDUSTRY