Dysport® Treatment of Urinary Incontinence in Adults Subjects With Neurogenic Detrusor Overactivity (NDO) Due to Spinal Cord Injury or Multiple Sclerosis - Study 2
- Conditions
- Urinary IncontinenceOveractive Bladder
- Interventions
- Biological: Botulinum toxin type ADrug: Placebo
- Registration Number
- NCT02660359
- Lead Sponsor
- Ipsen
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 258
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 600 U Dysport® Group Botulinum toxin type A - 600 U Dysport® Placebo Group Placebo - 800 U Dysport® Group Botulinum toxin type A - 800 U Dysport® Placebo Group Placebo -
- Primary Outcome Measures
Name Time Method Mean Change From Baseline in Weekly Number of UI Episodes at Week 6 of DBPC Cycle Baseline and 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.
- Secondary Outcome Measures
Name Time Method Mean Change From Baseline in Maximum Detrusor Pressure (MDP) During Storage at Week 6 of DBPC Cycle Baseline and Week 6 of DBPC Cycle Subjects included in the urodynamic subset (84.9% of randomised subjects) had a standardised urodynamic filling cystometry assessment at baseline (Screening) and again at Week 6 to determine the MDP. The LS mean of the change in MDP at 6 weeks after the first study treatment was calculated using an ANCOVA.
Percentage of Subjects With No Episodes of UI at Week 6 of DBPC Cycle Baseline and 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 number of subjects with no UI episodes at 6 weeks after the first study treatment was recorded. Percentage of subjects with no episodes of UI (≥100% Improvement) was calculated as: Total number of subjects with no weekly number of UI episodes at Week 6 / Total number of subjects with any number of UI events at Week 6.
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 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 percentage of subjects showing an improvement of ≥30%, ≥50% and ≥75% was calculated as: Total number of subjects with UI response level \>=30% or \>=50% or \>=75% improvement at Week 6 / Total number of subjects with any UI response at Week 6.
Mean Change From Baseline in Volume Per Void at Week 6 of DBPC Cycle Baseline and Week 6 of DBPC Cycle The volume per void was measured during one 24-hour period of the 7-day bladder diary. The LS mean of the change in volume per void at 6 weeks after the first study treatment was calculated using a MMRM analysis.
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 Subjects included in the urodynamic subset (84.9% of randomised subjects) had a standardised urodynamic filling cystometry assessment at baseline (Screening) and again at Week 6 to determine the Vol@1stIDC which is the instilled volume when first IDC commences. Subjects who did not exhibit a post-treatment IDC at Week 6 had Vol@1stIDC imputed using the recorded corrected MCC volume at Week 6. The LS mean of the change in Vol@1stIDC at 6 weeks after the first study treatment was calculated using an ANCOVA.
Median Time Between Treatments Day of first treatment (baseline) to day of retreatment, up to 2 years Duration of effect for time between treatments was calculated by: (the date of the first retreatment visit - date of first treatment administration in the DBPC cycle). The median number of days between treatments was determined and subjects with no retreatment were censored at the last visit.
Mean Change From Baseline in Maximum Cystometric Capacity (MCC) at Week 6 of DBPC Cycle Baseline and Week 6 of DBPC Cycle Subjects included in the urodynamic subset (84.9% of randomised subjects) had a standardised urodynamic filling cystometry assessment at baseline (Screening) and again at Week 6 to determine the MCC. The LS mean of the change in MCC at 6 weeks after the first study treatment was calculated using an analysis of covariance (ANCOVA).
Percentage of Subjects With No Involuntary Detrusor Contraction (IDCs) During Storage at Week 6 of DBPC Cycle Baseline and Week 6 of DBPC Cycle Subjects included in the urodynamic subset (84.9% of randomised subjects) had a standardised urodynamic filling cystometry assessment at baseline (Screening) and again at Week 6 to determine the occurrence of IDCs. The percentage of subjects without IDCs at 6 weeks after the first study treatment was recorded.
Trial Locations
- Locations (82)
Asociacion IPS Medicos Internistas de Caldas
🇨🇴Manizales, Colombia
Clínica Uromed
🇨🇱Santiago, Chile
Solano & Terront Servicios Medicos LTDA- Unidad Integral de Endocrinologia
🇨🇴Bogotá, Colombia
Centro Medico Puerta de Hierro - Colima
🇲🇽Colima, Mexico
Instituto de Ginecología y Reproducción
🇵🇪Lima, Peru
Kiev City Clinical Hospital No. 3
🇺🇦Kiev, Ukraine
Hospital Privado - Centro Médico de Córdoba
🇦🇷Córdoba, Argentina
Instituto Urológico Buenos Aires
🇦🇷Buenos Aires, Argentina
Antwerp University hospital
🇧🇪Antwerp, Belgium
Prince of Wales Hospital (POWH)
🇦🇺Sydney, Australia
Universidade Estadual de Campinas - Cidade Universitária Zeferino Vaz
🇧🇷Campinas, Brazil
Westmead Hospital
🇦🇺Westmead, Australia
Hospital de Clinicas, Federal University of Paraná
🇧🇷Curitiba, Brazil
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
🇧🇷Sao Paulo, Brazil
Centro Medico Imbanaco
🇨🇴Cali, Colombia
Meir Medical Center
🇮🇱Kfar Saba, Israel
Hôpital de la Conception
🇫🇷Marseille CEDEX 5, France
Rambam Medical Center
🇮🇱Haifa, Israel
Rabin Medical Center - Davidoff Center
🇮🇱Petah Tikva, Israel
Scientific research institute of urology and interventional radiology n. a. N. A. Lopatkin
🇷🇺Moscow, Russian Federation
Vilnius University Hospital Santariskiu Klinikos
🇱🇹Vilnius, Lithuania
Consultorio Privado
🇲🇽Zapopan, Mexico
Fundacio Puigvert
🇪🇸Barcelona, Spain
Fundació GAEM
🇪🇸Barcelona, Spain
Hospital Universitario Virgen del Rocío
🇪🇸Sevilla, Spain
Royal National Orthopaedic Hospital Trust
🇬🇧Stanmore, United Kingdom
Centro de Urologia
🇦🇷Buenos Aires, Argentina
Hôpital Erasme
🇧🇪Brussels, Belgium
Instituto Médico Rodriguez Alfici
🇦🇷Godoy Cruz, Argentina
Ourthe-Amblève
🇧🇪Esneux, Belgium
Hospital São Vicente de Paulo
🇧🇷Passo Fundo, Brazil
Hospital São Lucas da PUCRS
🇧🇷Pôrto Alegre, Brazil
Hospital Alemão Oswaldo Cruz
🇧🇷São Paulo, Brazil
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
🇧🇷Ribeirao Preto, Brazil
Clínica Las Condes
🇨🇱Santiago, Chile
Fundación Valle del Lili
🇨🇴Cali, Colombia
Centro de Investigaciones Clinicas - CIC
🇨🇴Medellin, Colombia
Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez
🇫🇷Lille Cedex, France
Groupe Hospitalo-Universitaire Pierre Caremau
🇫🇷Nimes Cedex 9, France
Hopital de la Source
🇫🇷Orleans, France
Hôpital Tenon
🇫🇷Paris Cedex 20, France
Hopital Pitie-Salpetriere
🇫🇷Paris, France
CHU de Rennes - Hôpital Pontchaillou
🇫🇷Rennes, France
Centre Hospitalier Lyon-Sud
🇫🇷Pierre-Bénite, France
CHU de ROUEN - Hôpital Charles Nicolle
🇫🇷Rouen Cedex, France
Hôpital Rangueil
🇫🇷Toulouse Cedex 9, France
Kliniken Maria Hilf GmbH - Krankenhaus St. Franziskus
🇩🇪Monchengladbach, Germany
Universitätsklinikum Münster
🇩🇪Münster, Germany
Carmel Medical Center
🇮🇱Haifa, Israel
The Chaim Sheba Medical Center
🇮🇱Ramat Gan, Israel
Estetines Chirurgijos Centas, UAB
🇱🇹Kaunas, Lithuania
Clinica Internacional Sede Lima
🇵🇪Lima, Peru
Hospital Universitario "Dr. José Eleuterio González"
🇲🇽Monterrey, Mexico
Clínica San Pablo Surco
🇵🇪Lima, Peru
Clinstile, S.A. de C.V.
🇲🇽Cuauhtémoc, Mexico
Clinica Good Hope
🇵🇪Lima, Peru
Clínica Anglo Americana
🇵🇪Lima, Peru
Ministry of healthcare of the Russian Federation
🇷🇺Moscow, Russian Federation
Unidad de Investigación de la Clínica Internacional Sede San Borja
🇵🇪Lima, Peru
Rostov State Medical University
🇷🇺Rostov-on-Don, Russian Federation
Hospital Orkli
🇷🇺Saint Petersburg, Russian Federation
Complexo Hospitalario Universitario A Coruña
🇪🇸A Coruña, Spain
St. Petersburg Research Institute of Phthisiopulmonology
🇷🇺Saint Petersburg, Russian Federation
City Hospital No. 40
🇷🇺Saint Petersburg, Russian Federation
Hospital Universitario Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Universitari i Politècnic La Fe
🇪🇸Valencia, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
National Hospital for Neurology and Neurosurgery - UCL
🇬🇧London, United Kingdom
Bedford Hospital
🇬🇧Bedford, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust - Royal Hallamshire Hospital
🇬🇧Sheffield, United Kingdom
The Mid Yorkshire Hospitals NHS Trust - Pinderfields Hospital
🇬🇧Wakefield, United Kingdom
Centro Urológico Profesor Bengió
🇦🇷Córdoba, Argentina
Hospital Moinhos de Vento
🇧🇷Pôrto Alegre, Brazil
Hôpital Raymond-Poincaré
🇫🇷Garches, France
Faculdade de Medicina do ABC
🇧🇷Santo André, Brazil
Universitätsklinikum Bonn Klinik und Poliklinik für Urologie
🇩🇪Bonn, Germany
Santa Casa de Misericórdia de Porto Alegre - Hospital Santa Clara
🇧🇷Porto Alegre, Brazil
Penza Regional Clinical Hospital n.a. N.N.Burdenko
🇷🇺Penza, Russian Federation
Pavlov First Saint Petersburg State Medical University
🇷🇺Saint Petersburg, Russian Federation
NHS Grampian - Aberdeen Royal Infirmary
🇬🇧Aberdeen, United Kingdom
Hospital del Trabajador
🇨🇱Santiago, Chile
Municipal Healthcare Institution "Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval", Urology Department
🇺🇦Kharkiv, Ukraine