Study Stopped
Slow recruitment of patients
Dysport® Treatment of Urinary Incontinence in Adults Subjects With Neurogenic Detrusor Overactivity (NDO) Due to Spinal Cord Injury or Multiple Sclerosis - Study 2
CONTENT2
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
2 other identifiers
interventional
258
16 countries
82
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2016
Typical duration for phase_3
82 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 14, 2016
CompletedFirst Posted
Study publicly available on registry
January 21, 2016
CompletedStudy Start
First participant enrolled
July 8, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 9, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 4, 2019
CompletedResults Posted
Study results publicly available
June 16, 2021
CompletedSeptember 28, 2022
September 1, 2022
2.3 years
January 14, 2016
May 21, 2021
September 15, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Mean Change From Baseline in Weekly Number of UI Episodes at Week 6 of DBPC Cycle
The weekly number of UI episodes was measured using a 7-day bladder diary. Bladder diaries that contained data recorded on at least 5 days were included in the analysis. The least square (LS) mean of the change in weekly number of UI episodes at 6 weeks after the first study treatment was calculated using a mixed model repeated measures (MMRM) analysis.
Baseline and Week 6 of DBPC Cycle
Secondary Outcomes (8)
Percentage of Subjects With No Episodes of UI at Week 6 of DBPC Cycle
Baseline and Week 6 of DBPC Cycle
Percentage of Subjects With a UI Response at Improvement Levels ≥30%, ≥50%, and ≥75% at Week 6 of the DBPC Cycle
Baseline and Week 6 of DBPC Cycle
Median Time Between Treatments
Day of first treatment (baseline) to day of retreatment, up to 2 years
Mean Change From Baseline in Volume Per Void at Week 6 of DBPC Cycle
Baseline and Week 6 of DBPC Cycle
Mean Change From Baseline in Maximum Cystometric Capacity (MCC) at Week 6 of DBPC Cycle
Baseline and Week 6 of DBPC Cycle
- +3 more secondary outcomes
Study Arms (4)
600 U Dysport® Group
EXPERIMENTAL600 U Dysport® Placebo Group
PLACEBO COMPARATOR800 U Dysport® Group
EXPERIMENTAL800 U Dysport® Placebo Group
PLACEBO COMPARATORInterventions
600 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points.
AbobotulinumtoxinA Placebo 600 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (82)
Instituto Urológico Buenos Aires
Buenos Aires, 1060, Argentina
Centro de Urologia
Buenos Aires, C1120AAS, Argentina
Centro Urológico Profesor Bengió
Córdoba, X5000, Argentina
Hospital Privado - Centro Médico de Córdoba
Córdoba, X5016KEH, Argentina
Instituto Médico Rodriguez Alfici
Godoy Cruz, M5501AAP, Argentina
Prince of Wales Hospital (POWH)
Sydney, 2031, Australia
Westmead Hospital
Westmead, 2145, Australia
Antwerp University hospital
Antwerp, Belgium
Hôpital Erasme
Brussels, 1070, Belgium
Ourthe-Amblève
Esneux, 4130, Belgium
Universidade Estadual de Campinas - Cidade Universitária Zeferino Vaz
Campinas, 13083-970, Brazil
Hospital de Clinicas, Federal University of Paraná
Curitiba, 80060-900, Brazil
Hospital São Vicente de Paulo
Passo Fundo, 99010-080, Brazil
Santa Casa de Misericórdia de Porto Alegre - Hospital Santa Clara
Porto Alegre, 90020-090, Brazil
Hospital Moinhos de Vento
Pôrto Alegre, 90560-030, Brazil
Hospital São Lucas da PUCRS
Pôrto Alegre, 90610-000, Brazil
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Ribeirão Preto, 14048-900, Brazil
Faculdade de Medicina do ABC
Santo André, 09060-650, Brazil
Hospital Alemão Oswaldo Cruz
São Paulo, 01323-020, Brazil
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, 05422-970, Brazil
Clínica Uromed
Santiago, 7500787, Chile
Hospital del Trabajador
Santiago, 7501241, Chile
Clínica Las Condes
Santiago, 7591046, Chile
Solano & Terront Servicios Medicos LTDA- Unidad Integral de Endocrinologia
Bogotá, 110221, Colombia
Fundación Valle del Lili
Cali, 760032, Colombia
Centro Medico Imbanaco
Cali, 760042, Colombia
Asociacion IPS Medicos Internistas de Caldas
Manizales, 170004, Colombia
Centro de Investigaciones Clinicas - CIC
Medellín, 5001000, 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, 53127, Germany
Kliniken Maria Hilf GmbH - Krankenhaus St. Franziskus
Mönchengladbach, Germany
Universitätsklinikum Münster
Münster, 48149, Germany
Rambam Medical Center
Haifa, 31096, Israel
Carmel Medical Center
Haifa, 34362, Israel
Meir Medical Center
Kfar Saba, 44281, Israel
Rabin Medical Center - Davidoff Center
Petah Tikva, 49100, Israel
The Chaim Sheba Medical Center
Ramat Gan, 52621, Israel
Estetines Chirurgijos Centas, UAB
Kaunas, 49476, Lithuania
Vilnius University Hospital Santariskiu Klinikos
Vilnius, 8661, Lithuania
Centro Medico Puerta de Hierro - Colima
Colima, 28018, Mexico
Clinstile, S.A. de C.V.
Cuauhtémoc, 06700, Mexico
Hospital Universitario "Dr. José Eleuterio González"
Monterrey, 64460, Mexico
Consultorio Privado
Zapopan, 45040, Mexico
Clínica San Pablo Surco
Lima, 15023, Peru
Clinica Good Hope
Lima, Lima18, Peru
Clinica Internacional Sede Lima
Lima, Lima1, Peru
Clínica Anglo Americana
Lima, Lima27, Peru
Instituto de Ginecología y Reproducción
Lima, Lima33, Peru
Unidad de Investigación de la Clínica Internacional Sede San Borja
Lima, Lima41, Peru
Scientific research institute of urology and interventional radiology n. a. N. A. Lopatkin
Moscow, 105425, Russia
Ministry of healthcare of the Russian Federation
Moscow, 129226, Russia
Penza Regional Clinical Hospital n.a. N.N.Burdenko
Penza, 440026, Russia
Rostov State Medical University
Rostov-on-Don, 344022, Russia
St. Petersburg Research Institute of Phthisiopulmonology
Saint Petersburg, 194064, Russia
Pavlov First Saint Petersburg State Medical University
Saint Petersburg, 197089, Russia
City Hospital No. 40
Saint Petersburg, 197706, Russia
Hospital Orkli
Saint Petersburg, Russia
Complexo Hospitalario Universitario A Coruña
A Coruña, Spain
Fundacio Puigvert
Barcelona, 08025, 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, 61037, Ukraine
Kiev City Clinical Hospital No. 3
Kiev, 02125, Ukraine
NHS Grampian - Aberdeen Royal Infirmary
Aberdeen, AB25 2ZN, United Kingdom
Bedford Hospital
Bedford, MK42 9DJ, United Kingdom
National Hospital for Neurology and Neurosurgery - UCL
London, WC1N 3BG, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust - Royal Hallamshire Hospital
Sheffield, S10 2JF, United Kingdom
Royal National Orthopaedic Hospital Trust
Stanmore, HA7 4LP, United Kingdom
The Mid Yorkshire Hospitals NHS Trust - Pinderfields Hospital
Wakefield, WF1 4DG, United Kingdom
Related Publications (1)
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.
PMID: 35400537DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
This study was terminated early by the sponsor on 04 October 2018, due to slow subject recruitment (258 subjects randomised compared to 330 planned subjects). Only primary and key secondary efficacy analyses were performed.
Results Point of Contact
- Title
- Medical Director
- Organization
- Ipsen
Study Officials
- STUDY DIRECTOR
Ipsen Medical Director
Ipsen
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2016
First Posted
January 21, 2016
Study Start
July 8, 2016
Primary Completion
November 9, 2018
Study Completion
July 4, 2019
Last Updated
September 28, 2022
Results First Posted
June 16, 2021
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
- Access Criteria
- Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of study participants. Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.