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Dysport® Treatment of Urinary Incontinence in Adults Subjects With Neurogenic Detrusor Overactivity (NDO) Due to Spinal Cord Injury or Multiple Sclerosis - Study 2 (CONTENT2)

Primary Purpose

Urinary Incontinence, Overactive Bladder

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Botulinum toxin type A
Botulinum toxin type A
Placebo
Placebo
Sponsored by
Ipsen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Instituto Urológico Buenos Aires
  • Centro de Urologia
  • Centro Urológico Profesor Bengió
  • Hospital Privado - Centro Médico de Córdoba
  • Instituto Médico Rodriguez Alfici
  • Prince of Wales Hospital (POWH)
  • Westmead Hospital
  • Antwerp University hospital
  • Hôpital Erasme
  • Ourthe-Amblève
  • Universidade Estadual de Campinas - Cidade Universitária Zeferino Vaz
  • Hospital de Clinicas, Federal University of Paraná
  • Hospital São Vicente de Paulo
  • Santa Casa de Misericórdia de Porto Alegre - Hospital Santa Clara
  • Hospital Moinhos de Vento
  • Hospital São Lucas da PUCRS
  • Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
  • Faculdade de Medicina do ABC
  • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
  • Hospital Alemão Oswaldo Cruz
  • Clínica Uromed
  • Hospital del Trabajador
  • Clínica Las Condes
  • Solano & Terront Servicios Medicos LTDA- Unidad Integral de Endocrinologia
  • Fundación Valle del Lili
  • Centro Medico Imbanaco
  • Asociacion IPS Medicos Internistas de Caldas
  • Centro de Investigaciones Clinicas - CIC
  • Hôpital Raymond-Poincaré
  • Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez
  • Hôpital de la Conception
  • Groupe Hospitalo-Universitaire Pierre Caremau
  • Hopital de la Source
  • Hôpital Tenon
  • Hopital Pitie-Salpetriere
  • Centre Hospitalier Lyon-Sud
  • CHU de Rennes - Hôpital Pontchaillou
  • CHU de ROUEN - Hôpital Charles Nicolle
  • Hôpital Rangueil
  • Universitätsklinikum Bonn Klinik und Poliklinik für Urologie
  • Kliniken Maria Hilf GmbH - Krankenhaus St. Franziskus
  • Universitätsklinikum Münster
  • Rambam Medical Center
  • Carmel Medical Center
  • Meir Medical Center
  • Rabin Medical Center - Davidoff Center
  • The Chaim Sheba Medical Center
  • Estetines Chirurgijos Centas, UAB
  • Vilnius University Hospital Santariskiu Klinikos
  • Centro Medico Puerta de Hierro - Colima
  • Clinstile, S.A. de C.V.
  • Hospital Universitario "Dr. José Eleuterio González"
  • Consultorio Privado
  • Clínica San Pablo Surco
  • Clinica Good Hope
  • Clinica Internacional Sede Lima
  • Clínica Anglo Americana
  • Instituto de Ginecología y Reproducción
  • Unidad de Investigación de la Clínica Internacional Sede San Borja
  • Scientific research institute of urology and interventional radiology n. a. N. A. Lopatkin
  • Ministry of healthcare of the Russian Federation
  • Penza Regional Clinical Hospital n.a. N.N.Burdenko
  • Rostov State Medical University
  • St. Petersburg Research Institute of Phthisiopulmonology
  • Pavlov First Saint Petersburg State Medical University
  • City Hospital No. 40
  • Hospital Orkli
  • Complexo Hospitalario Universitario A Coruña
  • Fundacio Puigvert
  • Fundació GAEM
  • Hospital Universitario Vall d'Hebron
  • Hospital Universitario La Paz
  • Hospital Universitario Virgen del Rocío
  • Hospital Universitari i Politècnic La Fe
  • Municipal Healthcare Institution "Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval", Urology Department
  • Kiev City Clinical Hospital No. 3
  • NHS Grampian - Aberdeen Royal Infirmary
  • Bedford Hospital
  • National Hospital for Neurology and Neurosurgery - UCL
  • Sheffield Teaching Hospitals NHS Foundation Trust - Royal Hallamshire Hospital
  • Royal National Orthopaedic Hospital Trust
  • The Mid Yorkshire Hospitals NHS Trust - Pinderfields Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

600 U Dysport® Group

600 U Dysport® Placebo Group

800 U Dysport® Group

800 U Dysport® Placebo Group

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percentage of Subjects With No Episodes of UI 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 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
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.
Median Time Between Treatments
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 Volume Per Void at 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 Maximum Cystometric Capacity (MCC) at 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).
Mean Change From Baseline in Maximum Detrusor Pressure (MDP) During Storage at 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.
Mean Change From Baseline in Volume at First Involuntary Detrusor Contraction (Vol@1stIDC) at 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.
Percentage of Subjects With No Involuntary Detrusor Contraction (IDCs) During Storage at 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.

Full Information

First Posted
January 14, 2016
Last Updated
September 15, 2022
Sponsor
Ipsen
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1. Study Identification

Unique Protocol Identification Number
NCT02660359
Brief Title
Dysport® Treatment of Urinary Incontinence in Adults Subjects With Neurogenic Detrusor Overactivity (NDO) Due to Spinal Cord Injury or Multiple Sclerosis - Study 2
Acronym
CONTENT2
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

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Terminated
Why Stopped
Slow recruitment of patients
Study Start Date
July 8, 2016 (Actual)
Primary Completion Date
November 9, 2018 (Actual)
Study Completion Date
July 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ipsen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Overactive Bladder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
258 (Actual)

8. Arms, Groups, and Interventions

Arm Title
600 U Dysport® Group
Arm Type
Experimental
Arm Title
600 U Dysport® Placebo Group
Arm Type
Placebo Comparator
Arm Title
800 U Dysport® Group
Arm Type
Experimental
Arm Title
800 U Dysport® Placebo Group
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
Botulinum toxin type A
Other Intervention Name(s)
AbobotulinumtoxinA (Dysport®), Clostridium BTX-A-haemagglutinin complex
Intervention Description
600 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points.
Intervention Type
Biological
Intervention Name(s)
Botulinum toxin type A
Other Intervention Name(s)
AbobotulinumtoxinA (Dysport®), Clostridium BTX-A-haemagglutinin complex
Intervention Description
800 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
AbobotulinumtoxinA Placebo 600 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
AbobotulinumtoxinA Placebo 800 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points
Primary Outcome Measure Information:
Title
Mean Change From Baseline in Weekly Number of UI Episodes at Week 6 of DBPC Cycle
Description
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.
Time Frame
Baseline and Week 6 of DBPC Cycle
Secondary Outcome Measure Information:
Title
Percentage of Subjects With No Episodes of UI at Week 6 of DBPC Cycle
Description
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.
Time Frame
Baseline and Week 6 of DBPC Cycle
Title
Percentage of Subjects With a UI Response at Improvement Levels ≥30%, ≥50%, and ≥75% at Week 6 of the DBPC Cycle
Description
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.
Time Frame
Baseline and Week 6 of DBPC Cycle
Title
Median Time Between Treatments
Description
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.
Time Frame
Day of first treatment (baseline) to day of retreatment, up to 2 years
Title
Mean Change From Baseline in Volume Per Void at Week 6 of DBPC Cycle
Description
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.
Time Frame
Baseline and Week 6 of DBPC Cycle
Title
Mean Change From Baseline in Maximum Cystometric Capacity (MCC) at Week 6 of DBPC Cycle
Description
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).
Time Frame
Baseline and Week 6 of DBPC Cycle
Title
Mean Change From Baseline in Maximum Detrusor Pressure (MDP) During Storage at Week 6 of DBPC Cycle
Description
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.
Time Frame
Baseline and Week 6 of DBPC Cycle
Title
Mean Change From Baseline in Volume at First Involuntary Detrusor Contraction (Vol@1stIDC) at Week 6 of DBPC Cycle
Description
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.
Time Frame
Baseline and Week 6 of DBPC Cycle
Title
Percentage of Subjects With No Involuntary Detrusor Contraction (IDCs) During Storage at Week 6 of DBPC Cycle
Description
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.
Time Frame
Baseline and Week 6 of DBPC Cycle

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ipsen Medical Director
Organizational Affiliation
Ipsen
Official's Role
Study Director
Facility Information:
Facility Name
Instituto Urológico Buenos Aires
City
Buenos Aires
ZIP/Postal Code
1060
Country
Argentina
Facility Name
Centro de Urologia
City
Buenos Aires
ZIP/Postal Code
C1120AAS
Country
Argentina
Facility Name
Centro Urológico Profesor Bengió
City
Córdoba
ZIP/Postal Code
X5000
Country
Argentina
Facility Name
Hospital Privado - Centro Médico de Córdoba
City
Córdoba
ZIP/Postal Code
X5016KEH
Country
Argentina
Facility Name
Instituto Médico Rodriguez Alfici
City
Godoy Cruz
ZIP/Postal Code
M5501AAP
Country
Argentina
Facility Name
Prince of Wales Hospital (POWH)
City
Sydney
ZIP/Postal Code
2031
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
ZIP/Postal Code
2145
Country
Australia
Facility Name
Antwerp University hospital
City
Antwerp
Country
Belgium
Facility Name
Hôpital Erasme
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Ourthe-Amblève
City
Esneux
ZIP/Postal Code
4130
Country
Belgium
Facility Name
Universidade Estadual de Campinas - Cidade Universitária Zeferino Vaz
City
Campinas
ZIP/Postal Code
13083-970
Country
Brazil
Facility Name
Hospital de Clinicas, Federal University of Paraná
City
Curitiba
ZIP/Postal Code
80060-900
Country
Brazil
Facility Name
Hospital São Vicente de Paulo
City
Passo Fundo
ZIP/Postal Code
99010-080
Country
Brazil
Facility Name
Santa Casa de Misericórdia de Porto Alegre - Hospital Santa Clara
City
Porto Alegre
ZIP/Postal Code
90020-090
Country
Brazil
Facility Name
Hospital Moinhos de Vento
City
Pôrto Alegre
ZIP/Postal Code
90560-030
Country
Brazil
Facility Name
Hospital São Lucas da PUCRS
City
Pôrto Alegre
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
City
Ribeirao Preto
ZIP/Postal Code
14048-900
Country
Brazil
Facility Name
Faculdade de Medicina do ABC
City
Santo André
ZIP/Postal Code
09060-650
Country
Brazil
Facility Name
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
City
Sao Paulo
ZIP/Postal Code
05422-970
Country
Brazil
Facility Name
Hospital Alemão Oswaldo Cruz
City
São Paulo
ZIP/Postal Code
01323-020
Country
Brazil
Facility Name
Clínica Uromed
City
Santiago
ZIP/Postal Code
7500787
Country
Chile
Facility Name
Hospital del Trabajador
City
Santiago
ZIP/Postal Code
7501241
Country
Chile
Facility Name
Clínica Las Condes
City
Santiago
ZIP/Postal Code
7591046
Country
Chile
Facility Name
Solano & Terront Servicios Medicos LTDA- Unidad Integral de Endocrinologia
City
Bogotá
ZIP/Postal Code
110221
Country
Colombia
Facility Name
Fundación Valle del Lili
City
Cali
ZIP/Postal Code
760032
Country
Colombia
Facility Name
Centro Medico Imbanaco
City
Cali
ZIP/Postal Code
760042
Country
Colombia
Facility Name
Asociacion IPS Medicos Internistas de Caldas
City
Manizales
ZIP/Postal Code
170004
Country
Colombia
Facility Name
Centro de Investigaciones Clinicas - CIC
City
Medellin
ZIP/Postal Code
5001000
Country
Colombia
Facility Name
Hôpital Raymond-Poincaré
City
Garches
Country
France
Facility Name
Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez
City
Lille Cedex
Country
France
Facility Name
Hôpital de la Conception
City
Marseille CEDEX 5
Country
France
Facility Name
Groupe Hospitalo-Universitaire Pierre Caremau
City
Nimes Cedex 9
Country
France
Facility Name
Hopital de la Source
City
Orleans
Country
France
Facility Name
Hôpital Tenon
City
Paris Cedex 20
Country
France
Facility Name
Hopital Pitie-Salpetriere
City
Paris
Country
France
Facility Name
Centre Hospitalier Lyon-Sud
City
Pierre-Bénite
Country
France
Facility Name
CHU de Rennes - Hôpital Pontchaillou
City
Rennes
Country
France
Facility Name
CHU de ROUEN - Hôpital Charles Nicolle
City
Rouen Cedex
Country
France
Facility Name
Hôpital Rangueil
City
Toulouse Cedex 9
Country
France
Facility Name
Universitätsklinikum Bonn Klinik und Poliklinik für Urologie
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Kliniken Maria Hilf GmbH - Krankenhaus St. Franziskus
City
Monchengladbach
Country
Germany
Facility Name
Universitätsklinikum Münster
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Carmel Medical Center
City
Haifa
ZIP/Postal Code
34362
Country
Israel
Facility Name
Meir Medical Center
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
Facility Name
Rabin Medical Center - Davidoff Center
City
Petah Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
The Chaim Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Estetines Chirurgijos Centas, UAB
City
Kaunas
ZIP/Postal Code
49476
Country
Lithuania
Facility Name
Vilnius University Hospital Santariskiu Klinikos
City
Vilnius
ZIP/Postal Code
8661
Country
Lithuania
Facility Name
Centro Medico Puerta de Hierro - Colima
City
Colima
ZIP/Postal Code
28018
Country
Mexico
Facility Name
Clinstile, S.A. de C.V.
City
Cuauhtémoc
ZIP/Postal Code
06700
Country
Mexico
Facility Name
Hospital Universitario "Dr. José Eleuterio González"
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Consultorio Privado
City
Zapopan
ZIP/Postal Code
45040
Country
Mexico
Facility Name
Clínica San Pablo Surco
City
Lima
ZIP/Postal Code
15023
Country
Peru
Facility Name
Clinica Good Hope
City
Lima
ZIP/Postal Code
Lima18
Country
Peru
Facility Name
Clinica Internacional Sede Lima
City
Lima
ZIP/Postal Code
Lima1
Country
Peru
Facility Name
Clínica Anglo Americana
City
Lima
ZIP/Postal Code
Lima27
Country
Peru
Facility Name
Instituto de Ginecología y Reproducción
City
Lima
ZIP/Postal Code
Lima33
Country
Peru
Facility Name
Unidad de Investigación de la Clínica Internacional Sede San Borja
City
Lima
ZIP/Postal Code
Lima41
Country
Peru
Facility Name
Scientific research institute of urology and interventional radiology n. a. N. A. Lopatkin
City
Moscow
ZIP/Postal Code
105425
Country
Russian Federation
Facility Name
Ministry of healthcare of the Russian Federation
City
Moscow
ZIP/Postal Code
129226
Country
Russian Federation
Facility Name
Penza Regional Clinical Hospital n.a. N.N.Burdenko
City
Penza
ZIP/Postal Code
440026
Country
Russian Federation
Facility Name
Rostov State Medical University
City
Rostov-on-Don
ZIP/Postal Code
344022
Country
Russian Federation
Facility Name
St. Petersburg Research Institute of Phthisiopulmonology
City
Saint Petersburg
ZIP/Postal Code
194064
Country
Russian Federation
Facility Name
Pavlov First Saint Petersburg State Medical University
City
Saint Petersburg
ZIP/Postal Code
197089
Country
Russian Federation
Facility Name
City Hospital No. 40
City
Saint Petersburg
ZIP/Postal Code
197706
Country
Russian Federation
Facility Name
Hospital Orkli
City
Saint Petersburg
Country
Russian Federation
Facility Name
Complexo Hospitalario Universitario A Coruña
City
A Coruña
Country
Spain
Facility Name
Fundacio Puigvert
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Fundació GAEM
City
Barcelona
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebron
City
Barcelona
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocío
City
Sevilla
Country
Spain
Facility Name
Hospital Universitari i Politècnic La Fe
City
Valencia
Country
Spain
Facility Name
Municipal Healthcare Institution "Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval", Urology Department
City
Kharkiv
ZIP/Postal Code
61037
Country
Ukraine
Facility Name
Kiev City Clinical Hospital No. 3
City
Kiev
ZIP/Postal Code
02125
Country
Ukraine
Facility Name
NHS Grampian - Aberdeen Royal Infirmary
City
Aberdeen
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
Facility Name
Bedford Hospital
City
Bedford
ZIP/Postal Code
MK42 9DJ
Country
United Kingdom
Facility Name
National Hospital for Neurology and Neurosurgery - UCL
City
London
ZIP/Postal Code
WC1N 3BG
Country
United Kingdom
Facility Name
Sheffield Teaching Hospitals NHS Foundation Trust - Royal Hallamshire Hospital
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom
Facility Name
Royal National Orthopaedic Hospital Trust
City
Stanmore
ZIP/Postal Code
HA7 4LP
Country
United Kingdom
Facility Name
The Mid Yorkshire Hospitals NHS Trust - Pinderfields Hospital
City
Wakefield
ZIP/Postal Code
WF1 4DG
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing 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.
IPD Sharing Access Criteria
Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
IPD Sharing URL
https://vivli.org/members/ourmembers/

Learn more about this trial

Dysport® Treatment of Urinary Incontinence in Adults Subjects With Neurogenic Detrusor Overactivity (NDO) Due to Spinal Cord Injury or Multiple Sclerosis - Study 2

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