Dysport® Treatment of Urinary Incontinence in Adults Subjects With Neurogenic Detrusor Overactivity (NDO) Due to Spinal Cord Injury or Multiple Sclerosis - Study 1
NCT ID: NCT02660138
Last Updated: 2022-09-28
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE3
227 participants
INTERVENTIONAL
2016-03-31
2019-02-14
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Dysport® Treatment of Urinary Incontinence in Adults Subjects With Neurogenic Detrusor Overactivity (NDO) Due to Spinal Cord Injury or Multiple Sclerosis - Study 2
NCT02660359
Neurogenic Detrusor Overactivity Following Spinal Cord Injury or Multiple Sclerosis
NCT01357980
Intravesical Injection of Botulinum Toxin A Versus Saline for Neurogenic Detrusor Overactivity
NCT01091727
Efficacy and Safety Study of Botulinum Toxin Type-A (Dysport®) in Continent Female Subjects Suffering From Idiopathic Overactive Bladder
NCT00578097
NEUROTOX: Two Dosages of Type A Botulinic Toxin in Neurogenic Overactive Bladder
NCT00213577
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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
Meet the organizations funding or collaborating on the study and learn about their roles.
Ipsen
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ipsen Medical Director
Role: STUDY_DIRECTOR
Ipsen
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UAB School of Medicine Spain Rehabilitation Center (SRC)
Birmingham, Alabama, United States
Urological Associates of Southern Arizona, P.C.
Tucson, Arizona, United States
Atlantic Urology Medical Group
Long Beach, California, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
UC Davis Medical Center
Sacramento, California, United States
University of Colorado Denver
Aurora, Colorado, United States
Women's Health Specialty Care
Farmington, Connecticut, United States
Gousse Urology - The Bladder Heath and Reconstructive Urology Institute
Miramar, Florida, United States
The Iowa Clinic, PC
West Des Moines, Iowa, United States
Chesapeake Urology Associates, PA
Owings Mills, Maryland, United States
University of Michigan Hospital
Ann Arbor, Michigan, United States
Weill Cornell Medical College
Denville, New Jersey, United States
Delaware Valley Urology,IIC
Voorhees Township, New Jersey, United States
Urology Group of New Mexico, PC
Albuquerque, New Mexico, United States
New York University Langone Medical Center and School of Medicine
New York, New York, United States
New York-Presbyterian Hospital/Weill Cornell Medical Center
New York, New York, United States
Advanced Urology Centers of New York
Plainview, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
University of North Carolina School of Medicine
Chapel Hill, North Carolina, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Louis Stokes Cleveland Veterans Affairs Medical Center
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Lancaster Urology
Lancaster, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Urology Clinics of North Texas
Dallas, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
Lahey Hospital & Medical Center
Burlington, Vermont, United States
Urology of Virginia, PLLC
Virginia Beach, Virginia, United States
Integrity Medical Research
Mountlake Terrace, Washington, United States
Medical College of Wisconsin - Freodert Hospital
Milwaukee, Wisconsin, United States
CHUS - Hôpital Fleurimont
Sherbrooke, , Canada
Sunnybrook Health Sciences Centre
Toronto, , Canada
UBC Hospital - Koerner Pavilion
Vancouver, , Canada
Spinal Cord Research Centre, University of Manitoba
Winnipeg, , Canada
Fakultní Nemocnice Brno
Brno, , Czechia
Karlovarska krajska nemocnice, a.s.
Karlovy Vary, , Czechia
Krajská Nemocnice Liberec, a.s.
Liberec, , Czechia
Uromedical Center s.r.o.
Olomouc, , Czechia
Fakultní nemocnice Královské Vinohrady
Prague, , Czechia
Všeobecná fakultní nemocnice v Praze
Prague, , Czechia
Thomayerova nemocnice
Prague, , Czechia
Fakultní Nemocnice v Motole
Prague, , Czechia
Urologicka Ordinace s.r.o.
Sternberk, , Czechia
Azienda Ospedaliero-Universitaria Careggi - Dipartimento Di Neuro-Urologia
Florence, , Italy
Farmacia Istituto Ospedaliero ICOT "Marco Pasquali"
Latina, , Italy
Azienda Ospedaliera di Perugia - Ospedale Santa Maria della Misericordia
Perugia, , Italy
Viale Oxford, 81
Roma, , Italy
Ospedale "Bolognini" di Seriate
Seriate, , Italy
Azienda Ospedaliera di Perugia - Ospedale Santa Maria della Misericordia
Udine, , Italy
VU University Medical Center
Amsterdam, , Netherlands
Radboud UMC
Nijmegen, , Netherlands
Erasmus MC
Rotterdam, , Netherlands
Wojewódzki Szpital Zespolony w Elblągu
Elblag, , Poland
Nzoz Neuro-Medic Poradnia Wielospecjalistyczna
Katowice, , Poland
NZOZ Heureka
Piaseczno, , Poland
Szpital Kliniczny Dzieciątka Jezus w Warszawie
Warsaw, , Poland
EuroMediCare Szpital Specjalistyczny z Przychodnią we Wrocławiu
Wroclaw, , Poland
Hospital de Braga
Braga, , Portugal
Centro Hospitalar do Alto Ave, EPE
Guimarães, , Portugal
British Hospital
Lisbon, , Portugal
Centro Hospitalar do Porto, EPE - Hospital Geral de Santo António
Porto, , Portugal
Centro Hospitalar de São João, EPE - Hospital de São João
Porto, , Portugal
Gnosis Evomed
Bucharest, , Romania
Spitalul Clinic Colentina
Bucharest, , Romania
Spitalul Clinic Fundeni Bucureşti
Bucharest, , Romania
Hifu Terramed Conformal S.R.L
Bucharest, , Romania
Spitalul Clinic Judeţean Mureş
Târgu Mureş, , Romania
88 Olympic-ro 43-gil, Songpa-gu
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Ulsan University Hospital (UUH)
Ulsan, , South Korea
Ankara Üniversitesi Tıp Fakültesi
Ankara, , Turkey (Türkiye)
Medipol Mega University Hospital
Bağcılar, , Turkey (Türkiye)
Uludag Universitesi Tip Fakultesi, Uroloji Anabilim Dali, Gorukle
Bursa, , Turkey (Türkiye)
Marmara Üniversitesi Eğitim ve Araştırma Hastanesi
Istanbul, , Turkey (Türkiye)
Istanbul Medeniyet Universitesi Goztepe Egitim ve Arastirma Hastanesi Merdivenköy Mah
Istanbul, , Turkey (Türkiye)
Erciyes Üniversitesi Tıp Fakültesi
Kayseri, , Turkey (Türkiye)
Kocaeli Üniversitesi Tıp Fakültesi
Kocaeli, , Turkey (Türkiye)
Celal Bayar Universitesi Hafsa Sultan Hastanesi
Manisa, , Turkey (Türkiye)
Ondokuz Mayıs Üniversitesi Tıp Fakültesi
Samsun, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2015-003471-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D-FR-52120-222
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.