Study Stopped
Low 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 1
CONTENT1
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
227
10 countries
81
Brief Summary
The purpose of this study is to provide confirmatory evidence of the safety and efficacy of two Dysport® (AbobotulinumtoxinA) 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 P25-P50 for phase_3
Started Mar 2016
Typical duration for phase_3
81 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
March 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 9, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 14, 2019
CompletedResults Posted
Study results publicly available
June 16, 2021
CompletedSeptember 28, 2022
September 1, 2022
2.7 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 (9)
Mean Change From Baseline in Maximum Cystometric Capacity (MCC) at Week 6 of DBPC Cycle
Baseline and Week 6 of DBPC Cycle
Mean Change From Baseline in Maximum Detrusor Pressure (MDP) at Week 6 of DBPC Cycle
Baseline and Week 6 of DBPC Cycle
Mean Change From Baseline in Volume at First Involuntary Detrusor Contraction (Vol@1stIDC) at Week 6 of DBPC Cycle
Baseline and Week 6 of DBPC Cycle
Number of Subjects With No Episodes of UI at Week 6 of DBPC Cycle
Baseline and Week 6 of DBPC Cycle
Number of Subjects With No IDCs During Storage at Week 6 of DBPC Cycle
Baseline and Week 6 of DBPC Cycle
- +4 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 (81)
UAB School of Medicine Spain Rehabilitation Center (SRC)
Birmingham, Alabama, 35249, United States
Urological Associates of Southern Arizona, P.C.
Tucson, Arizona, 85715-3808, United States
Atlantic Urology Medical Group
Long Beach, California, 90806, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90089, United States
UC Davis Medical Center
Sacramento, California, 95817-2307, United States
University of Colorado Denver
Aurora, Colorado, 80045-2527, United States
Women's Health Specialty Care
Farmington, Connecticut, 06032-1933, United States
Gousse Urology - The Bladder Heath and Reconstructive Urology Institute
Miramar, Florida, 33029-5593, United States
The Iowa Clinic, PC
West Des Moines, Iowa, 50266, United States
Chesapeake Urology Associates, PA
Owings Mills, Maryland, 21117, United States
University of Michigan Hospital
Ann Arbor, Michigan, 48109, United States
Weill Cornell Medical College
Denville, New Jersey, 07834, United States
Delaware Valley Urology,IIC
Voorhees Township, New Jersey, 08043, United States
Urology Group of New Mexico, PC
Albuquerque, New Mexico, 87109, United States
New York University Langone Medical Center and School of Medicine
New York, New York, 10016, United States
New York-Presbyterian Hospital/Weill Cornell Medical Center
New York, New York, 10065, United States
Advanced Urology Centers of New York
Plainview, New York, 11783, United States
Montefiore Medical Center
The Bronx, New York, 10461, United States
University of North Carolina School of Medicine
Chapel Hill, North Carolina, 27599, United States
Levine Cancer Institute
Charlotte, North Carolina, 28207, United States
Louis Stokes Cleveland Veterans Affairs Medical Center
Cleveland, Ohio, 44106, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Lancaster Urology
Lancaster, Pennsylvania, 17601, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Urology Clinics of North Texas
Dallas, Texas, 75231, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
Lahey Hospital & Medical Center
Burlington, Vermont, 01805-0001, United States
Urology of Virginia, PLLC
Virginia Beach, Virginia, 23462-1815, United States
Integrity Medical Research
Mountlake Terrace, Washington, 98043, United States
Medical College of Wisconsin - Freodert Hospital
Milwaukee, Wisconsin, 53226, United States
CHUS - Hôpital Fleurimont
Sherbrooke, 02114-2621, Canada
Sunnybrook Health Sciences Centre
Toronto, 02115-6110, Canada
UBC Hospital - Koerner Pavilion
Vancouver, V6T 2B5, Canada
Spinal Cord Research Centre, University of Manitoba
Winnipeg, R3A 1M4, Canada
Fakultní Nemocnice Brno
Brno, 62500, Czechia
Karlovarska krajska nemocnice, a.s.
Karlovy Vary, 360 01, Czechia
Krajská Nemocnice Liberec, a.s.
Liberec, 46063, Czechia
Uromedical Center s.r.o.
Olomouc, 77900, Czechia
Fakultní nemocnice Královské Vinohrady
Prague, 100 34, Czechia
Všeobecná fakultní nemocnice v Praze
Prague, 12808, Czechia
Thomayerova nemocnice
Prague, 14059, Czechia
Fakultní Nemocnice v Motole
Prague, 15006, Czechia
Urologicka Ordinace s.r.o.
Sternberk, 785 01, Czechia
Azienda Ospedaliero-Universitaria Careggi - Dipartimento Di Neuro-Urologia
Florence, 50134, Italy
Farmacia Istituto Ospedaliero ICOT "Marco Pasquali"
Latina, 04100, Italy
Azienda Ospedaliera di Perugia - Ospedale Santa Maria della Misericordia
Perugia, 06132, Italy
Viale Oxford, 81
Roma, 00133, Italy
Ospedale "Bolognini" di Seriate
Seriate, 24068, Italy
Azienda Ospedaliera di Perugia - Ospedale Santa Maria della Misericordia
Udine, 33100, Italy
VU University Medical Center
Amsterdam, 1081 HV, Netherlands
Radboud UMC
Nijmegen, 6525 GA, Netherlands
Erasmus MC
Rotterdam, 3015 CE, Netherlands
Wojewódzki Szpital Zespolony w Elblągu
Elblag, 82-300, Poland
Nzoz Neuro-Medic Poradnia Wielospecjalistyczna
Katowice, 40-752, Poland
NZOZ Heureka
Piaseczno, 05-500, Poland
Szpital Kliniczny Dzieciątka Jezus w Warszawie
Warsaw, 02-005, Poland
EuroMediCare Szpital Specjalistyczny z Przychodnią we Wrocławiu
Wroclaw, 54-144, Poland
Hospital de Braga
Braga, 4700-001, Portugal
Centro Hospitalar do Alto Ave, EPE
Guimarães, 4835-044, Portugal
British Hospital
Lisbon, 1600-209, Portugal
Centro Hospitalar do Porto, EPE - Hospital Geral de Santo António
Porto, 4099-001, Portugal
Centro Hospitalar de São João, EPE - Hospital de São João
Porto, 4200-319, Portugal
Gnosis Evomed
Bucharest, 031864, Romania
Spitalul Clinic Colentina
Bucharest, 20125, Romania
Spitalul Clinic Fundeni Bucureşti
Bucharest, 22328, Romania
Hifu Terramed Conformal S.R.L
Bucharest, 31864, Romania
Spitalul Clinic Judeţean Mureş
Târgu Mureş, 540103, Romania
88 Olympic-ro 43-gil, Songpa-gu
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 6351, South Korea
Ulsan University Hospital (UUH)
Ulsan, 44033, South Korea
Ankara Üniversitesi Tıp Fakültesi
Ankara, 6100, Turkey (Türkiye)
Medipol Mega University Hospital
Bağcılar, 34200, Turkey (Türkiye)
Uludag Universitesi Tip Fakultesi, Uroloji Anabilim Dali, Gorukle
Bursa, 16059, Turkey (Türkiye)
Marmara Üniversitesi Eğitim ve Araştırma Hastanesi
Istanbul, 34670, Turkey (Türkiye)
Istanbul Medeniyet Universitesi Goztepe Egitim ve Arastirma Hastanesi Merdivenköy Mah
Istanbul, 34732, Turkey (Türkiye)
Erciyes Üniversitesi Tıp Fakültesi
Kayseri, 38039, Turkey (Türkiye)
Kocaeli Üniversitesi Tıp Fakültesi
Kocaeli, 41380, Turkey (Türkiye)
Celal Bayar Universitesi Hafsa Sultan Hastanesi
Manisa, 45040, Turkey (Türkiye)
Ondokuz Mayıs Üniversitesi Tıp Fakültesi
Samsun, 55139, Turkey (Türkiye)
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 01 October 2018, due to low subject recruitment.
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
March 1, 2016
Primary Completion
November 9, 2018
Study Completion
February 14, 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.