Clinical trial NCT02660138: Dysport® Treatment of Urinary Incontinence in Adults Subjects With Neurogenic Detrusor Overactivity (NDO) Due to Spinal Cord Injury or Multiple Sclerosis - Study 1
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: 227
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® (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).


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: 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) 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: Number of Subjects With No Episodes of UI at Week 6 of DBPC Cycle
timeFrame: Baseline and Week 6 of DBPC Cycle
measure: Number of Subjects With No IDCs During Storage at Week 6 of DBPC Cycle
timeFrame: Baseline and Week 6 of DBPC Cycle
measure: Mean Change From Baseline in Incontinence Quality of Life (I-QoL) Questionnaire Total Summary Score at Week 6 of DBPC Cycle
timeFrame: Baseline and Week 6 of DBPC Cycle
measure: Number 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: Mean Change From Baseline in Volume Per Void at Week 6 of DBPC Cycle
timeFrame: Baseline and Week 6 of DBPC Cycle
measure: Median Time Between Treatments
timeFrame: Day of first treatment (baseline) and day of retreatment, up to 2 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB School of Medicine Spain Rehabilitation Center (SRC)
state: Alabama
city: Tucson
country: United States
facility: Urological Associates of Southern Arizona, P.C.
state: Arizona
city: Long Beach
country: United States
facility: Atlantic Urology Medical Group
state: California
city: Los Angeles
country: United States
facility: USC Norris Comprehensive Cancer Center
state: California
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: Farmington
country: United States
facility: Women's Health Specialty Care
state: Connecticut
city: Miramar
country: United States
facility: Gousse Urology - The Bladder Heath and Reconstructive Urology Institute
state: Florida
city: West Des Moines
country: United States
facility: The Iowa Clinic, PC
state: Iowa
city: Owings Mills
country: United States
facility: Chesapeake Urology Associates, PA
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan Hospital
state: Michigan
city: Denville
country: United States
facility: Weill Cornell Medical College
state: New Jersey
city: Voorhees
country: United States
facility: Delaware Valley Urology,IIC
state: New Jersey
city: Albuquerque
country: United States
facility: Urology Group of New Mexico, PC
state: New Mexico
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: New York University Langone Medical Center and School of Medicine
state: New York
city: New York
country: United States
facility: New York-Presbyterian Hospital/Weill Cornell Medical Center
state: New York
city: Plainview
country: United States
facility: Advanced Urology Centers of New York
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina School of Medicine
state: North Carolina
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
city: Cleveland
country: United States
facility: Louis Stokes Cleveland Veterans Affairs Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Lancaster
country: United States
facility: Lancaster Urology
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina (MUSC)
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Urology Clinics of North Texas
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Burlington
country: United States
facility: Lahey Hospital & Medical Center
state: Vermont
city: Virginia Beach
country: United States
facility: Urology of Virginia, PLLC
state: Virginia
city: Mountlake Terrace
country: United States
facility: Integrity Medical Research
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin - Freodert Hospital
state: Wisconsin
city: Sherbrooke
country: Canada
facility: CHUS - Hôpital Fleurimont
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
city: Vancouver
country: Canada
facility: UBC Hospital - Koerner Pavilion
city: Winnipeg
country: Canada
facility: Spinal Cord Research Centre, University of Manitoba
city: Brno
country: Czechia
facility: Fakultní Nemocnice Brno
city: Karlovy Vary
country: Czechia
facility: Karlovarska krajska nemocnice, a.s.
city: Liberec
country: Czechia
facility: Krajská Nemocnice Liberec, a.s.
city: Olomouc
country: Czechia
facility: Uromedical Center s.r.o.
city: Praha 10
country: Czechia
facility: Fakultní nemocnice Královské Vinohrady
city: Praha 2
country: Czechia
facility: Všeobecná fakultní nemocnice v Praze
city: Praha 5
country: Czechia
facility: Fakultní Nemocnice v Motole
city: Praha
country: Czechia
facility: Thomayerova nemocnice
city: Sternberk
country: Czechia
facility: Urologicka Ordinace s.r.o.
city: Firenze
country: Italy
facility: Azienda Ospedaliero-Universitaria Careggi - Dipartimento Di Neuro-Urologia
city: Latina
country: Italy
facility: Farmacia Istituto Ospedaliero ICOT "Marco Pasquali"
city: Perugia
country: Italy
facility: Azienda Ospedaliera di Perugia - Ospedale Santa Maria della Misericordia
city: Roma
country: Italy
facility: Viale Oxford, 81
city: Seriate
country: Italy
facility: Ospedale "Bolognini" di Seriate
city: Udine
country: Italy
facility: Azienda Ospedaliera di Perugia - Ospedale Santa Maria della Misericordia
city: Seoul
country: Korea, Republic of
facility: 88 Olympic-ro 43-gil, Songpa-gu
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital (UUH)
city: Amsterdam
country: Netherlands
facility: VU University Medical Center
city: Nijmegen
country: Netherlands
facility: Radboud UMC
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Elblag
country: Poland
facility: Wojewódzki Szpital Zespolony w Elblągu
city: Katowice
country: Poland
facility: Nzoz Neuro-Medic Poradnia Wielospecjalistyczna
city: Piaseczno
country: Poland
facility: NZOZ Heureka
city: Warszawa
country: Poland
facility: Szpital Kliniczny Dzieciątka Jezus w Warszawie
city: Wroclaw
country: Poland
facility: EuroMediCare Szpital Specjalistyczny z Przychodnią we Wrocławiu
city: Braga
country: Portugal
facility: Hospital de Braga
city: Guimarães
country: Portugal
facility: Centro Hospitalar do Alto Ave, EPE
city: Lisboa
country: Portugal
facility: British Hospital
city: Porto
country: Portugal
facility: Centro Hospitalar do Porto, EPE - Hospital Geral de Santo António
city: Porto
country: Portugal
facility: Centro Hospitalar de São João, EPE - Hospital de São João
city: Bucharest
country: Romania
facility: Gnosis Evomed
city: Bucharest
country: Romania
facility: Spitalul Clinic Colentina
city: Bucharest
country: Romania
facility: Spitalul Clinic Fundeni Bucureşti
city: Bucharest
country: Romania
facility: Hifu Terramed Conformal S.R.L
city: Târgu-Mureş
country: Romania
facility: Spitalul Clinic Judeţean Mureş
city: Ankara
country: Turkey
facility: Ankara Üniversitesi Tıp Fakültesi
city: Bagcilar
country: Turkey
facility: Medipol Mega University Hospital
city: Bursa
country: Turkey
facility: Uludag Universitesi Tip Fakultesi, Uroloji Anabilim Dali, Gorukle
city: Istanbul
country: Turkey
facility: Marmara Üniversitesi Eğitim ve Araştırma Hastanesi
city: Istanbul
country: Turkey
facility: Istanbul Medeniyet Universitesi Goztepe Egitim ve Arastirma Hastanesi Merdivenköy Mah
city: Kayseri
country: Turkey
facility: Erciyes Üniversitesi Tıp Fakültesi
city: Kocaeli
country: Turkey
facility: Kocaeli Üniversitesi Tıp Fakültesi
city: Manisa
country: Turkey
facility: Celal Bayar Universitesi Hafsa Sultan Hastanesi
city: Samsun
country: Turkey
facility: Ondokuz Mayıs Üniversitesi Tıp Fakültesi
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: