Clinical trial NCT02660359: Dysport® Treatment of Urinary Incontinence in Adults Subjects With Neurogenic Detrusor Overactivity (NDO) Due to Spinal Cord Injury or Multiple Sclerosis - Study 2
Official title: A Phase III, Multicentre, Randomised, Double Blind, Parallel Group, Placebo Controlled Study To Assess The Efficacy And Safety Of One Or More Intradetrusor Treatments Of 600 Or 800 Units Of Dysport® For The Treatment Of Urinary Incontinence In Subjects With Neurogenic Detrusor Overactivity Due To Spinal Cord Injury Or Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Urinary Incontinence
Overactive Bladder
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2016-01-21
Enrollment: 258
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to provide confirmatory evidence of the safety and efficacy of two Dysport® 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: Key Inclusion Criteria:

* Urinary Incontinence for at least 3 months prior to Screening as a result of Neurogenic Detrusor Overactivity due to Spinal Cord Injury or Multiple Sclerosis.
* 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.

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 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.

Primary outcomes:
measure: Mean Change From Baseline in Weekly Number of UI Episodes at Week 6 of DBPC Cycle
timeFrame: Baseline and Week 6 of DBPC Cycle
Secondary outcomes:
measure: Percentage of Subjects With No Episodes of UI at Week 6 of DBPC Cycle
timeFrame: Baseline and Week 6 of DBPC Cycle
measure: Percentage of Subjects With a UI Response at Improvement Levels ≥30%, ≥50%, and ≥75% at Week 6 of the DBPC Cycle
timeFrame: Baseline and Week 6 of DBPC Cycle
measure: Median Time Between Treatments
timeFrame: Day of first treatment (baseline) to day of retreatment, up to 2 years
measure: Mean Change From Baseline in Volume Per Void at Week 6 of DBPC Cycle
timeFrame: Baseline and Week 6 of DBPC Cycle
measure: Mean Change From Baseline in Maximum Cystometric Capacity (MCC) at Week 6 of DBPC Cycle
timeFrame: Baseline and Week 6 of DBPC Cycle
measure: Mean Change From Baseline in Maximum Detrusor Pressure (MDP) During Storage at Week 6 of DBPC Cycle
timeFrame: Baseline and Week 6 of DBPC Cycle
measure: Mean Change From Baseline in Volume at First Involuntary Detrusor Contraction (Vol@1stIDC) at Week 6 of DBPC Cycle
timeFrame: Baseline and Week 6 of DBPC Cycle
measure: Percentage of Subjects With No Involuntary Detrusor Contraction (IDCs) During Storage at Week 6 of DBPC Cycle
timeFrame: Baseline and Week 6 of DBPC Cycle
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Instituto Urológico Buenos Aires
city: Buenos Aires
country: Argentina
facility: Centro de Urologia
city: Córdoba
country: Argentina
facility: Centro Urológico Profesor Bengió
city: Córdoba
country: Argentina
facility: Hospital Privado - Centro Médico de Córdoba
city: Godoy Cruz
country: Argentina
facility: Instituto Médico Rodriguez Alfici
city: Sydney
country: Australia
facility: Prince of Wales Hospital (POWH)
city: Westmead
country: Australia
facility: Westmead Hospital
city: Antwerp
country: Belgium
facility: Antwerp University hospital
city: Brussels
country: Belgium
facility: Hôpital Erasme
city: Esneux
country: Belgium
facility: Ourthe-Amblève
city: Campinas
country: Brazil
facility: Universidade Estadual de Campinas - Cidade Universitária Zeferino Vaz
city: Curitiba
country: Brazil
facility: Hospital de Clinicas, Federal University of Paraná
city: Passo Fundo
country: Brazil
facility: Hospital São Vicente de Paulo
city: Porto Alegre
country: Brazil
facility: Santa Casa de Misericórdia de Porto Alegre - Hospital Santa Clara
city: Pôrto Alegre
country: Brazil
facility: Hospital Moinhos de Vento
city: Pôrto Alegre
country: Brazil
facility: Hospital São Lucas da PUCRS
city: Ribeirao Preto
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
city: Santo André
country: Brazil
facility: Faculdade de Medicina do ABC
city: Sao Paulo
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
city: São Paulo
country: Brazil
facility: Hospital Alemão Oswaldo Cruz
city: Santiago
country: Chile
facility: Clínica Uromed
city: Santiago
country: Chile
facility: Hospital del Trabajador
city: Santiago
country: Chile
facility: Clínica Las Condes
city: Bogotá
country: Colombia
facility: Solano & Terront Servicios Medicos LTDA- Unidad Integral de Endocrinologia
city: Cali
country: Colombia
facility: Fundación Valle del Lili
city: Cali
country: Colombia
facility: Centro Medico Imbanaco
city: Manizales
country: Colombia
facility: Asociacion IPS Medicos Internistas de Caldas
city: Medellin
country: Colombia
facility: Centro de Investigaciones Clinicas - CIC
city: Garches
country: France
facility: Hôpital Raymond-Poincaré
city: Lille Cedex
country: France
facility: Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez
city: Marseille CEDEX 5
country: France
facility: Hôpital de la Conception
city: Nimes Cedex 9
country: France
facility: Groupe Hospitalo-Universitaire Pierre Caremau
city: Orleans
country: France
facility: Hopital de la Source
city: Paris Cedex 20
country: France
facility: Hôpital Tenon
city: Paris
country: France
facility: Hopital Pitie-Salpetriere
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon-Sud
city: Rennes
country: France
facility: CHU de Rennes - Hôpital Pontchaillou
city: Rouen Cedex
country: France
facility: CHU de ROUEN - Hôpital Charles Nicolle
city: Toulouse Cedex 9
country: France
facility: Hôpital Rangueil
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn Klinik und Poliklinik für Urologie
city: Monchengladbach
country: Germany
facility: Kliniken Maria Hilf GmbH - Krankenhaus St. Franziskus
city: Münster
country: Germany
facility: Universitätsklinikum Münster
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Haifa
country: Israel
facility: Carmel Medical Center
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Petah Tikva
country: Israel
facility: Rabin Medical Center - Davidoff Center
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center
city: Kaunas
country: Lithuania
facility: Estetines Chirurgijos Centas, UAB
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santariskiu Klinikos
city: Colima
country: Mexico
facility: Centro Medico Puerta de Hierro - Colima
city: Cuauhtémoc
country: Mexico
facility: Clinstile, S.A. de C.V.
city: Monterrey
country: Mexico
facility: Hospital Universitario "Dr. José Eleuterio González"
city: Zapopan
country: Mexico
facility: Consultorio Privado
city: Lima
country: Peru
facility: Clínica San Pablo Surco
city: Lima
country: Peru
facility: Clinica Good Hope
city: Lima
country: Peru
facility: Clinica Internacional Sede Lima
city: Lima
country: Peru
facility: Clínica Anglo Americana
city: Lima
country: Peru
facility: Instituto de Ginecología y Reproducción
city: Lima
country: Peru
facility: Unidad de Investigación de la Clínica Internacional Sede San Borja
city: Moscow
country: Russian Federation
facility: Scientific research institute of urology and interventional radiology n. a. N. A. Lopatkin
city: Moscow
country: Russian Federation
facility: Ministry of healthcare of the Russian Federation
city: Penza
country: Russian Federation
facility: Penza Regional Clinical Hospital n.a. N.N.Burdenko
city: Rostov-on-Don
country: Russian Federation
facility: Rostov State Medical University
city: Saint Petersburg
country: Russian Federation
facility: St. Petersburg Research Institute of Phthisiopulmonology
city: Saint Petersburg
country: Russian Federation
facility: Pavlov First Saint Petersburg State Medical University
city: Saint Petersburg
country: Russian Federation
facility: City Hospital No. 40
city: Saint Petersburg
country: Russian Federation
facility: Hospital Orkli
city: A Coruña
country: Spain
facility: Complexo Hospitalario Universitario A Coruña
city: Barcelona
country: Spain
facility: Fundacio Puigvert
city: Barcelona
country: Spain
facility: Fundació GAEM
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Valencia
country: Spain
facility: Hospital Universitari i Politècnic La Fe
city: Kharkiv
country: Ukraine
facility: Municipal Healthcare Institution "Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval", Urology Department
city: Kiev
country: Ukraine
facility: Kiev City Clinical Hospital No. 3
city: Aberdeen
country: United Kingdom
facility: NHS Grampian - Aberdeen Royal Infirmary
city: Bedford
country: United Kingdom
facility: Bedford Hospital
city: London
country: United Kingdom
facility: National Hospital for Neurology and Neurosurgery - UCL
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Foundation Trust - Royal Hallamshire Hospital
city: Stanmore
country: United Kingdom
facility: Royal National Orthopaedic Hospital Trust
city: Wakefield
country: United Kingdom
facility: The Mid Yorkshire Hospitals NHS Trust - Pinderfields Hospital
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: