Phase
Condition
Urinary Incontinence
Multiple Sclerosis
Spinal Cord Injuries
Treatment
N/AClinical Study ID
Ages 18-80 All Genders
Study Summary
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
Connect with a study center
Jonathan Giddens Medicine Professional Corp.
Brampton, L6T 4S5
CanadaSite Not Available
Jewish General Hospital
Montreal, H3T IE2
CanadaSite Not Available
The Fe/Male Health Centre
Oakville, L6H 3P1
CanadaSite Not Available
The Ottawa Hospital, Civic Campus
Ottawa, K1Y 4E9
CanadaSite Not Available
Diex Recherche
Québec City, G1M2S8
CanadaSite Not Available
CHUS - Hôpital Fleurimont
Sherbrooke, 02114-2621
CanadaSite Not Available
Sunnybrook Health Sciences Centre
Toronto, 02115-6110
CanadaSite Not Available
UBC Hospital - Koerner Pavilion
Vancouver, V6T 2B5
CanadaSite Not Available
Spinal Cord Research Centre, University of Manitoba
Winnipeg, R3A 1M4
CanadaSite Not Available
Fakultní Nemocnice Hradec Králové
Hradec Králové, 500 05
Czech RepublicSite Not Available
Agora Flora
Praha 3, 13000
Czech RepublicSite Not Available
Fakultní Nemocnice Brno
Brno, 62500
CzechiaSite Not Available
Karlovarska krajska nemocnice, a.s.
Karlovy Vary, 360 01
CzechiaSite Not Available
Krajská Nemocnice Liberec, a.s.
Liberec, 46063
CzechiaSite Not Available
Uromedical Center s.r.o.
Olomouc, 77900
CzechiaSite Not Available
Thomayerova nemocnice
Praha, 14059
CzechiaSite Not Available
Fakultní nemocnice Královské Vinohrady
Praha 10, 100 34
CzechiaSite Not Available
Všeobecná fakultní nemocnice v Praze
Praha 2, 12808
CzechiaSite Not Available
Fakultní Nemocnice v Motole
Praha 5, 15006
CzechiaSite Not Available
Urologicka Ordinace s.r.o.
Sternberk, 785 01
CzechiaSite Not Available
Azienda Ospedaliero-Universitaria Careggi - Dipartimento Di Neuro-Urologia
Firenze, 50134
ItalySite Not Available
Farmacia Istituto Ospedaliero ICOT "Marco Pasquali"
Latina, 04100
ItalySite Not Available
Ospedale San Raffaele - UO Di Urologia
Milano, 20132
ItalySite Not Available
Azienda Ospedaliera di Perugia - Ospedale Santa Maria della Misericordia
Perugia, 06132
ItalySite Not Available
Viale Oxford, 81
Roma, 00133
ItalySite Not Available
Ospedale "Bolognini" di Seriate
Seriate, 24068
ItalySite Not Available
Ospedale Di Treviglio - DIP Di Neuro-Urologia E Urodinamica
Treviglio, 24047
ItalySite Not Available
Ospedale Di Treviglio - DIP Di Neuro-Urologia E Urodinamica
Treviglio (Bergamo), 24047
ItalySite Not Available
Pia Fondazione Di Culto E Di Religione Cardinal G. Panico
Tricase, 73039
ItalySite Not Available
Pia Fondazione Di Culto E Di Religione Cardinal G. Panico
Tricase (Lecce), 73039
ItalySite Not Available
Azienda Ospedaliera di Perugia - Ospedale Santa Maria della Misericordia
Udine, 33100
ItalySite Not Available
88 Olympic-ro 43-gil, Songpa-gu
Seoul, 05505
Korea, Republic ofSite Not Available
Samsung Medical Center
Seoul, 6351
Korea, Republic ofSite Not Available
Ulsan University Hospital (UUH)
Ulsan, 44033
Korea, Republic ofSite Not Available
Jalan Yaacob Latiff, Bandar Tun Razak
Kuala Lumpur, 56000
MalaysiaSite Not Available
VU University Medical Center
Amsterdam, 1081 HV
NetherlandsSite Not Available
Radboud UMC
Nijmegen, 6525 GA
NetherlandsSite Not Available
Erasmus MC
Rotterdam, 3015 CE
NetherlandsSite Not Available
Universitair Medisch Centrum Utrecht
Utrecht, 3584 CX
NetherlandsSite Not Available
Wojewódzki Szpital Zespolony w Elblągu
Elblag, 82-300
PolandSite Not Available
Nzoz Neuro-Medic Poradnia Wielospecjalistyczna
Katowice, 40-752
PolandSite Not Available
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
Lublin, 20-954
PolandSite Not Available
NZOZ Heureka
Piaseczno, 05-500
PolandSite Not Available
Kliniczny Szpital Wojewódzki Nr 1 im. Fryderyka Chopina w Rzeszowie
Rzeszow, 35-055
PolandSite Not Available
Szpital Kliniczny Dzieciątka Jezus w Warszawie
Warszawa, 02-005
PolandSite Not Available
EuroMediCare Szpital Specjalistyczny z Przychodnią we Wrocławiu
Wroclaw, 54-144
PolandSite Not Available
Hospital de Braga
Braga, 4700-001
PortugalSite Not Available
Centro Hospitalar e Universitário de Coimbra, EPE - Hospitais da Universidade de Coimbra
Coimbra, 3000-075
PortugalSite Not Available
Centro Hospitalar do Alto Ave, EPE
Guimarães, 4835-044
PortugalSite Not Available
British Hospital
Lisboa, 1600-209
PortugalSite Not Available
Centro Hospitalar de São João, EPE - Hospital de São João
Porto, 4200-319
PortugalSite Not Available
Centro Hospitalar do Porto, EPE - Hospital Geral de Santo António
Porto, 4099-001
PortugalSite Not Available
Gnosis Evomed
Bucharest, 031864
RomaniaSite Not Available
Hifu Terramed Conformal S.R.L
Bucharest, 31864
RomaniaSite Not Available
Spitalul Clinic Colentina
Bucharest, 20125
RomaniaSite Not Available
Spitalul Clinic Fundeni Bucureşti
Bucharest, 22328
RomaniaSite Not Available
Spitalul Clinic Judeţean Mureş
Târgu-Mureş, 540103
RomaniaSite Not Available
Ankara Üniversitesi Tıp Fakültesi
Ankara, 6100
TurkeySite Not Available
Medipol Mega University Hospital
Bagcilar, 34200
TurkeySite Not Available
Uludag Universitesi Tip Fakultesi, Uroloji Anabilim Dali, Gorukle
Bursa, 16059
TurkeySite Not Available
Istanbul Medeniyet Universitesi Goztepe Egitim ve Arastirma Hastanesi Merdivenköy Mah
Istanbul, 34732
TurkeySite Not Available
Marmara Üniversitesi Eğitim ve Araştırma Hastanesi
Istanbul, 34670
TurkeySite Not Available
Erciyes Üniversitesi Tıp Fakültesi
Kayseri, 38039
TurkeySite Not Available
Kocaeli Üniversitesi Tıp Fakültesi
Kocaeli, 41380
TurkeySite Not Available
Celal Bayar Universitesi Hafsa Sultan Hastanesi
Manisa, 45040
TurkeySite Not Available
Ondokuz Mayıs Üniversitesi Tıp Fakültesi
Samsun, 55139
TurkeySite Not Available
UAB School of Medicine Spain Rehabilitation Center (SRC)
Birmingham, Alabama 35249
United StatesSite Not Available
Urological Associates of Southern Arizona, P.C.
Tucson, Arizona 85715-3808
United StatesSite Not Available
Applied Research Center of Arkansas
Little Rock, Arkansas 72212
United StatesSite Not Available
Orange County Urology Associates
Laguna Hills, California 92653
United StatesSite Not Available
Vanderbilt University Medical Center
Laguna Woods, California 92637
United StatesSite Not Available
Atlantic Urology Medical Group
Long Beach, California 90806
United StatesSite Not Available
USC Norris Comprehensive Cancer Center
Los Angeles, California 90089
United StatesSite Not Available
VA Palo Alto Health Care System
Palo Alto, California 94304
United StatesSite Not Available
UC Davis Medical Center
Sacramento, California 95817-2307
United StatesSite Not Available
University of Colorado Denver
Aurora, Colorado 80045-2527
United StatesSite Not Available
Women's Health Specialty Care
Farmington, Connecticut 06032-1933
United StatesSite Not Available
Gousse Urology - The Bladder Heath and Reconstructive Urology Institute
Miramar, Florida 33029-5593
United StatesSite Not Available
Idaho Urologic Institute
Meridian, Idaho 83642-6245
United StatesSite Not Available
The Iowa Clinic, PC
West Des Moines, Iowa 50266
United StatesSite Not Available
Regional Urology, LLC
Shreveport, Louisiana 71106
United StatesSite Not Available
MidAtlantic Urology Associates, LLC
Greenbelt, Maryland 20770
United StatesSite Not Available
Chesapeake Urology Associates, PA
Owings Mills, Maryland 21117
United StatesSite Not Available
University of Michigan Hospital
Ann Arbor, Michigan 48109
United StatesSite Not Available
Metro Urology (Woodbury)
Woodbury, Minnesota 55125
United StatesSite Not Available
Weill Cornell Medical College
Denville, New Jersey 07834
United StatesSite Not Available
Premier Urology Group
Edison, New Jersey 08837-2429
United StatesSite Not Available
Delaware Valley Urology,IIC
Voorhees, New Jersey 08043
United StatesSite Not Available
Urology Group of New Mexico, PC
Albuquerque, New Mexico 87109
United StatesSite Not Available
Montefiore Medical Center
Bronx, New York 10461
United StatesSite Not Available
New York University Langone Medical Center and School of Medicine
New York, New York 10016
United StatesSite Not Available
New York-Presbyterian Hospital/Weill Cornell Medical Center
New York, New York 10065
United StatesSite Not Available
Advanced Urology Centers of New York
Plainview, New York 11783
United StatesSite Not Available
Montefiore Medical Center
The Bronx, New York 10461
United StatesSite Not Available
University of North Carolina School of Medicine
Chapel Hill, North Carolina 27599
United StatesSite Not Available
Levine Cancer Institute
Charlotte, North Carolina 28207
United StatesSite Not Available
Alliance Urology Specialists
Greensboro, North Carolina 27403
United StatesSite Not Available
Cleveland Clinic
Cleveland, Ohio 44195
United StatesSite Not Available
Louis Stokes Cleveland Veterans Affairs Medical Center
Cleveland, Ohio 44106
United StatesSite Not Available
Lancaster Urology
Lancaster, Pennsylvania 17601
United StatesSite Not Available
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
Medical University of South Carolina (MUSC)
Charleston, South Carolina 29425
United StatesSite Not Available
Carolina Urologic Research Center, LLC
Myrtle Beach, South Carolina 29572-4607
United StatesSite Not Available
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United StatesSite Not Available
Urology Clinics of North Texas
Dallas, Texas 75231
United StatesSite Not Available
Houston Methodist Hospital
Houston, Texas 77030
United StatesSite Not Available
Lahey Hospital & Medical Center
Burlington, Vermont 01805-0001
United StatesSite Not Available
Urology of Virginia, PLLC
Virginia Beach, Virginia 23462-1815
United StatesSite Not Available
Integrity Medical Research
Mountlake Terrace, Washington 98043
United StatesSite Not Available
Zain Research
Richland, Washington 99352-4853
United StatesSite Not Available
Medical College of Wisconsin - Freodert Hospital
Milwaukee, Wisconsin 53226
United StatesSite Not Available
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