Dysport® Treatment of Urinary Incontinence in Adults Subjects With Neurogenic Detrusor Overactivity (NDO) Due to Spinal Cord Injury or Multiple Sclerosis - Study 2
NCT ID: NCT02660359
Last Updated: 2022-09-28
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
258 participants
INTERVENTIONAL
2016-07-08
2019-07-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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600 U Dysport® Group
Botulinum toxin type A
600 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points.
600 U Dysport® Placebo Group
Placebo
AbobotulinumtoxinA Placebo 600 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points
800 U Dysport® Group
Botulinum toxin type A
800 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points
800 U Dysport® Placebo Group
Placebo
AbobotulinumtoxinA Placebo 800 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points
Interventions
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Botulinum toxin type A
600 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points.
Botulinum toxin type A
800 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points
Placebo
AbobotulinumtoxinA Placebo 600 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points
Placebo
AbobotulinumtoxinA Placebo 800 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects with Spinal Cord Injury must have a stable neurological injury at T1 level or below which occurred at least 6 months prior to Screening.
* Subjects with Multiple Sclerosis must be clinically stable in the investigator's opinion, with no exacerbation (relapse) of MS for at least 3 months prior to Screening.
* Subjects must have had an inadequate response after at least 4 weeks of oral medications 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 adequate bladder emptying.
* An average of at least two episodes per day of Urinary Incontinence recorded on the screening bladder diary.
Exclusion Criteria
* 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 less than 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 off at least 4 weeks prior to Screening.
18 Years
80 Years
ALL
No
Sponsors
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Ipsen
INDUSTRY
Responsible Party
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Principal Investigators
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Ipsen Medical Director
Role: STUDY_DIRECTOR
Ipsen
Locations
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Instituto Urológico Buenos Aires
Buenos Aires, , Argentina
Centro de Urologia
Buenos Aires, , Argentina
Centro Urológico Profesor Bengió
Córdoba, , Argentina
Hospital Privado - Centro Médico de Córdoba
Córdoba, , Argentina
Instituto Médico Rodriguez Alfici
Godoy Cruz, , Argentina
Prince of Wales Hospital (POWH)
Sydney, , Australia
Westmead Hospital
Westmead, , Australia
Antwerp University hospital
Antwerp, , Belgium
Hôpital Erasme
Brussels, , Belgium
Ourthe-Amblève
Esneux, , Belgium
Universidade Estadual de Campinas - Cidade Universitária Zeferino Vaz
Campinas, , Brazil
Hospital de Clinicas, Federal University of Paraná
Curitiba, , Brazil
Hospital São Vicente de Paulo
Passo Fundo, , Brazil
Santa Casa de Misericórdia de Porto Alegre - Hospital Santa Clara
Porto Alegre, , Brazil
Hospital Moinhos de Vento
Pôrto Alegre, , Brazil
Hospital São Lucas da PUCRS
Pôrto Alegre, , Brazil
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Ribeirão Preto, , Brazil
Faculdade de Medicina do ABC
Santo André, , Brazil
Hospital Alemão Oswaldo Cruz
São Paulo, , Brazil
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, , Brazil
Clínica Uromed
Santiago, , Chile
Hospital del Trabajador
Santiago, , Chile
Clínica Las Condes
Santiago, , Chile
Solano & Terront Servicios Medicos LTDA- Unidad Integral de Endocrinologia
Bogotá, , Colombia
Fundación Valle del Lili
Cali, , Colombia
Centro Medico Imbanaco
Cali, , Colombia
Asociacion IPS Medicos Internistas de Caldas
Manizales, , Colombia
Centro de Investigaciones Clinicas - CIC
Medellín, , Colombia
Hôpital Raymond-Poincaré
Garches, , France
Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez
Lille, , France
Hôpital de la Conception
Marseille, , France
Groupe Hospitalo-Universitaire Pierre Caremau
Nîmes, , France
Hopital de la Source
Orléans, , France
Hopital Pitie-Salpetriere
Paris, , France
Hôpital Tenon
Paris, , France
Centre Hospitalier Lyon-Sud
Pierre-Bénite, , France
CHU de Rennes - Hôpital Pontchaillou
Rennes, , France
CHU de ROUEN - Hôpital Charles Nicolle
Rouen, , France
Hôpital Rangueil
Toulouse, , France
Universitätsklinikum Bonn Klinik und Poliklinik für Urologie
Bonn, , Germany
Kliniken Maria Hilf GmbH - Krankenhaus St. Franziskus
Mönchengladbach, , Germany
Universitätsklinikum Münster
Münster, , Germany
Rambam Medical Center
Haifa, , Israel
Carmel Medical Center
Haifa, , Israel
Meir Medical Center
Kfar Saba, , Israel
Rabin Medical Center - Davidoff Center
Petah Tikva, , Israel
The Chaim Sheba Medical Center
Ramat Gan, , Israel
Estetines Chirurgijos Centas, UAB
Kaunas, , Lithuania
Vilnius University Hospital Santariskiu Klinikos
Vilnius, , Lithuania
Centro Medico Puerta de Hierro - Colima
Colima, , Mexico
Clinstile, S.A. de C.V.
Cuauhtémoc, , Mexico
Hospital Universitario "Dr. José Eleuterio González"
Monterrey, , Mexico
Consultorio Privado
Zapopan, , Mexico
Clínica San Pablo Surco
Lima, , Peru
Clinica Good Hope
Lima, , Peru
Clinica Internacional Sede Lima
Lima, , Peru
Clínica Anglo Americana
Lima, , Peru
Instituto de Ginecología y Reproducción
Lima, , Peru
Unidad de Investigación de la Clínica Internacional Sede San Borja
Lima, , Peru
Scientific research institute of urology and interventional radiology n. a. N. A. Lopatkin
Moscow, , Russia
Ministry of healthcare of the Russian Federation
Moscow, , Russia
Penza Regional Clinical Hospital n.a. N.N.Burdenko
Penza, , Russia
Rostov State Medical University
Rostov-on-Don, , Russia
St. Petersburg Research Institute of Phthisiopulmonology
Saint Petersburg, , Russia
Pavlov First Saint Petersburg State Medical University
Saint Petersburg, , Russia
City Hospital No. 40
Saint Petersburg, , Russia
Hospital Orkli
Saint Petersburg, , Russia
Complexo Hospitalario Universitario A Coruña
A Coruña, , Spain
Fundacio Puigvert
Barcelona, , Spain
Fundació GAEM
Barcelona, , Spain
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Virgen del Rocío
Seville, , Spain
Hospital Universitari i Politècnic La Fe
Valencia, , Spain
Municipal Healthcare Institution "Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval", Urology Department
Kharkiv, , Ukraine
Kiev City Clinical Hospital No. 3
Kiev, , Ukraine
NHS Grampian - Aberdeen Royal Infirmary
Aberdeen, , United Kingdom
Bedford Hospital
Bedford, , United Kingdom
National Hospital for Neurology and Neurosurgery - UCL
London, , United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust - Royal Hallamshire Hospital
Sheffield, , United Kingdom
Royal National Orthopaedic Hospital Trust
Stanmore, , United Kingdom
The Mid Yorkshire Hospitals NHS Trust - Pinderfields Hospital
Wakefield, , United Kingdom
Countries
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References
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Kennelly M, Cruz F, Herschorn S, Abrams P, Onem K, Solomonov VK, Del Rosario Figueroa Coz E, Manu-Marin A, Giannantoni A, Thompson C, Vilain C, Volteau M, Denys P; Dysport CONTENT Program Group. Efficacy and Safety of AbobotulinumtoxinA in Patients with Neurogenic Detrusor Overactivity Incontinence Performing Regular Clean Intermittent Catheterization: Pooled Results from Two Phase 3 Randomized Studies (CONTENT1 and CONTENT2). Eur Urol. 2022 Aug;82(2):223-232. doi: 10.1016/j.eururo.2022.03.010. Epub 2022 Apr 7.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2015-000507-44
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D-FR-52120-223
Identifier Type: -
Identifier Source: org_study_id
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