Phase
Condition
Overactive Bladder
Memory Loss
Urinary Incontinence
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
Centro de Urologia
Buenos Aires, C1120AAS
ArgentinaSite Not Available
Instituto Urológico Buenos Aires
Buenos Aires, 1060
ArgentinaSite Not Available
Centro Urológico Profesor Bengió
Córdoba, X5000
ArgentinaSite Not Available
Hospital Privado - Centro Médico de Córdoba
Córdoba, X5016KEH
ArgentinaSite Not Available
Instituto Médico Rodriguez Alfici
Godoy Cruz, M5501AAP
ArgentinaSite Not Available
Repatriation General Hospital
Daw Park, 5041
AustraliaSite Not Available
Western Hospital
Footscray, 3011
AustraliaSite Not Available
Fiona Stanley Hospital
Murdoch, 6150
AustraliaSite Not Available
Prince of Wales Hospital (POWH)
Sydney, 2031
AustraliaSite Not Available
Westmead Hospital
Westmead, 2145
AustraliaSite Not Available
Antwerp University hospital
Antwerp,
BelgiumSite Not Available
Hôpital Erasme
Brussels, 1070
BelgiumSite Not Available
Ourthe-Amblève
Esneux, 4130
BelgiumSite Not Available
CHU de Liège - Site du Sart Tilman
Liège, 4000
BelgiumSite Not Available
Hospital Universitário São José
Belo Horizonte, 30140-073
BrazilSite Not Available
Universidade Estadual de Campinas - Cidade Universitária Zeferino Vaz
Campinas, 13083-970
BrazilSite Not Available
Hospital de Clinicas, Federal University of Paraná
Curitiba, 80060-900
BrazilSite Not Available
Hospital e Maternidade Teresinha de Jesus
Juiz de Fora, 36025-330
BrazilSite Not Available
Hospital São Vicente de Paulo
Passo Fundo, 99010-080
BrazilSite Not Available
Santa Casa de Misericórdia de Porto Alegre - Hospital Santa Clara
Porto Alegre, 90020-090
BrazilSite Not Available
Hospital Moinhos de Vento
Pôrto Alegre, 90560-030
BrazilSite Not Available
Hospital São Lucas da PUCRS
Pôrto Alegre, 90610-000
BrazilSite Not Available
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Ribeirao Preto, 14048-900
BrazilSite Not Available
Faculdade de Medicina do ABC
Santo André, 09060-650
BrazilSite Not Available
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Sao Paulo, 05422-970
BrazilSite Not Available
Hospital Alemão Oswaldo Cruz
São Paulo, 01323-020
BrazilSite Not Available
Clinica INDISA
Providencia, 7520279
ChileSite Not Available
Clínica Las Condes
Santiago, 7591046
ChileSite Not Available
Clínica Uromed
Santiago, 7500787
ChileSite Not Available
Hospital del Trabajador
Santiago, 7501241
ChileSite Not Available
Centro De Investigacion Clinica Del Sur, LTDA.
Temuco, 4781156
ChileSite Not Available
Fundación Cardio Infantil - Instituto de Cardiología
Bogota, 110131
ColombiaSite Not Available
MedPlus Medicina Prepagada S.A
Bogota D.C, 110221
ColombiaSite Not Available
Solano & Terront Servicios Medicos LTDA- Unidad Integral de Endocrinologia
Bogotá, 110221
ColombiaSite Not Available
Centro Medico Imbanaco
Cali, 760042
ColombiaSite Not Available
Fundación Valle del Lili
Cali, 760032
ColombiaSite Not Available
Asociacion IPS Medicos Internistas de Caldas
Manizales, 170004
ColombiaSite Not Available
Centro de Investigaciones Clinicas - CIC
Medellin, 5001000
ColombiaSite Not Available
CHU Hopitaux de Bordeaux - Groupe Hospitalier Pellegrin
Bordeaux,
FranceSite Not Available
CHU Dijon - Hopital du Bocage
Dijon Cedex,
FranceSite Not Available
Hôpital Raymond-Poincaré
Garches,
FranceSite Not Available
Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez
Lille Cedex,
FranceSite Not Available
Hôpital de la Conception
Marseille CEDEX 5,
FranceSite Not Available
Groupe Hospitalo-Universitaire Pierre Caremau
Nimes Cedex 9,
FranceSite Not Available
Hopital de la Source
Orleans,
FranceSite Not Available
Hopital Pitie-Salpetriere
Paris,
FranceSite Not Available
Hôpital Tenon
Paris Cedex 20,
FranceSite Not Available
Centre Hospitalier Lyon-Sud
Pierre-Bénite,
FranceSite Not Available
CHU de Rennes - Hôpital Pontchaillou
Rennes,
FranceSite Not Available
CHU de ROUEN - Hôpital Charles Nicolle
Rouen Cedex,
FranceSite Not Available
Hôpital Rangueil
Toulouse Cedex 9,
FranceSite Not Available
Universitätsklinikum Aachen
Aachen, 5207
GermanySite Not Available
Universitätsklinikum Bonn Klinik und Poliklinik für Urologie
Bonn, 53127
GermanySite Not Available
Kliniken Maria Hilf GmbH - Krankenhaus St. Franziskus
Monchengladbach,
GermanySite Not Available
Universitätsklinikum Bonn
Muehlacker,
GermanySite Not Available
Universitätsklinikum Münster
Mönchengladbach,
GermanySite Not Available
Universitätsklinikum Münster
Münster, 48149
GermanySite Not Available
Carmel Medical Center
Haifa, 34362
IsraelSite Not Available
Rambam Medical Center
Haifa, 31096
IsraelSite Not Available
Meir Medical Center
Kfar Saba, 44281
IsraelSite Not Available
Rabin Medical Center - Davidoff Center
Petah Tikva, 49100
IsraelSite Not Available
The Chaim Sheba Medical Center
Ramat Gan, 52621
IsraelSite Not Available
Estetines Chirurgijos Centas, UAB
Kaunas, 49476
LithuaniaSite Not Available
Vilnius University Hospital Santariskiu Klinikos
Vilnius, 8661
LithuaniaSite Not Available
Centro Medico Puerta de Hierro - Colima
Colima, 28018
MexicoSite Not Available
Clinstile, S.A. de C.V.
Cuauhtémoc, 06700
MexicoSite Not Available
UMAE Hospital de Especialidades Centro Medico Nacional Siglo XXI
Mexico City, _06720
MexicoSite Not Available
Clinstile, S.A. de C.V.
Mexico D.F., _06700
MexicoSite Not Available
Hospital Universitario "Dr. José Eleuterio González"
Monterrey, 64460
MexicoSite Not Available
Consultorio Privado
Zapopan, 45040
MexicoSite Not Available
Canterbury Urology Research Trust
Christchurch,
New ZealandSite Not Available
Tauranga Urology Research Ltd.
Tauranga,
New ZealandSite Not Available
Clinica Good Hope
Lima, Lima18
PeruSite Not Available
Clinica Internacional Sede Lima
Lima, Lima1
PeruSite Not Available
Clínica Anglo Americana
Lima, Lima27
PeruSite Not Available
Clínica San Pablo Surco
Lima, 15023
PeruSite Not Available
Instituto de Ginecología y Reproducción
Lima, Lima33
PeruSite Not Available
Unidad de Investigación de la Clínica Internacional Sede San Borja
Lima, Lima41
PeruSite Not Available
Ministry of healthcare of the Russian Federation
Moscow, 129226
Russian FederationSite Not Available
Scientific research institute of urology and interventional radiology n. a. N. A. Lopatkin
Moscow, 105425
Russian FederationSite Not Available
Penza Regional Clinical Hospital n.a. N.N.Burdenko
Penza, 440026
Russian FederationSite Not Available
Rostov State Medical University
Rostov-on-Don, 344022
Russian FederationSite Not Available
City Hospital No. 40
Saint Petersburg, 197706
Russian FederationSite Not Available
Hospital Orkli
Saint Petersburg,
Russian FederationSite Not Available
Pavlov First Saint Petersburg State Medical University
Saint Petersburg, 197089
Russian FederationSite Not Available
St. Petersburg Research Institute of Phthisiopulmonology
Saint Petersburg, 194064
Russian FederationSite Not Available
Complexo Hospitalario Universitario A Coruña
A Coruña,
SpainSite Not Available
Sanitas La Zarzuela Hospital
Aravaca,
SpainSite Not Available
Fundacio Puigvert
Barcelona, 08025
SpainSite Not Available
Fundació GAEM
Barcelona,
SpainSite Not Available
Hospital Universitario Vall d'Hebron
Barcelona,
SpainSite Not Available
Hospital Universitario De Canarias
La Laguna,
SpainSite Not Available
Hospital Universitario La Paz
Madrid,
SpainSite Not Available
Hospital Universitario Infanta Sofía
San Sebastián de Los Reyes,
SpainSite Not Available
Hospital Universitario Virgen del Rocío
Sevilla,
SpainSite Not Available
Hospital Universitari i Politècnic La Fe
Valencia,
SpainSite Not Available
Regional Public Institution "Chernivtsi Regional Clinical Hospital", Urology Department
Chernivtsi, 58001
UkraineSite Not Available
Municipal Healthcare Institution "Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval", Urology Department
Kharkiv, 61037
UkraineSite Not Available
Kiev City Clinical Hospital No. 3
Kiev, 02125
UkraineSite Not Available
MUNICIPAL INSTITUTION "ZAPORIZHZHIA STATE CLINICAL HOSPITAL" OF ZAPORIZHZHIA REGIONAL council
Zaporozh'ye, 69600
UkraineSite Not Available
NHS Grampian - Aberdeen Royal Infirmary
Aberdeen, AB25 2ZN
United KingdomSite Not Available
Bedford Hospital
Bedford, MK42 9DJ
United KingdomSite Not Available
North Bristol NHS Trust - Southmead Hospital Bristol
Bristol, BS10 5NB
United KingdomSite Not Available
Colchester Hospital University NHS Foundation Trust - Colchester General Hospital
Colchester, CO4 5JL
United KingdomSite Not Available
National Hospital for Neurology and Neurosurgery - UCL
London, WC1N 3BG
United KingdomSite Not Available
South Tees Hospitals NHS Foundation Trust - The James Cook University Hospital
Middlesbrough, TS4 3BW
United KingdomSite Not Available
Sheffield Teaching Hospitals NHS Foundation Trust - Royal Hallamshire Hospital
Sheffield, S10 2JF
United KingdomSite Not Available
Royal National Orthopaedic Hospital Trust
Stanmore, HA7 4LP
United KingdomSite Not Available
The Mid Yorkshire Hospitals NHS Trust - Pinderfields Hospital
Wakefield, WF1 4DG
United KingdomSite Not Available

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