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Neurogenic Detrusor Overactivity Following Spinal Cord Injury or Multiple Sclerosis

Primary Purpose

Detrusor Muscle Hyperactivity

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Botulinum toxin type A
Placebo
Sponsored by
Ipsen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Detrusor Muscle Hyperactivity focused on measuring Detrusor Muscle Overactivity

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject, family member or care giver was willing and able to perform clean intermittent catheterisation (CIC) for the duration of the study
  • Inadequate response or refractory to anticholinergic medication
  • Botulinum Toxin naive for intradetrusor injections and with no previous treatment with Botulinum Toxin of any type, within 3 months prior to study entry for any other condition
  • Have a minimum of 2 incontinences per day calculated as the average daily incontinence episode frequency (IEF) over the 3 days preceding the baseline visit

Exclusion Criteria:

  • Significant Baseline renal and/or urinary tract pathology
  • Previous treatment with any endovesical pharmacology agent including detrusor Botulinum Toxin injection

Sites / Locations

  • Faculty Hospital Motol
  • THOMAYER Faculty Hospital
  • Hopital Raymond Poincaré
  • Hopital HURIET
  • Hôpital Lyon Sud -Hospices Civils de Lyon
  • Hopital de la conception
  • CHU Hotel Dieu
  • Groupe Hospitalier La Pitié Salpetriere
  • Hopital Tenon
  • CMRRF Kerpape
  • CHU Rouen - Hopital Charles Nicolle
  • Nouvel Hopital civil de Strasbourg
  • CHU Toulouse - Hopital Rangueil
  • Universitätsklinik Kiel
  • Städtisches Klinikum Neunkirchen
  • Ospedale Careggi
  • NZOZ Centrum Medyczne Mazovia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Dysport 750 U (15 injection sites)

Placebo (15 injection sites)

Dysport 750 U (30 injection sites)

Placebo (30 injection sites)

Arm Description

Outcomes

Primary Outcome Measures

Daily Incontinence Episode Frequency (IEF)

Secondary Outcome Measures

Urodynamics: Maximum Cystometric Capacity
Maximum Cystometric Capacity is an urodynamic parameter that indicates the volume at which a patient feels he (she) can no longer delay release of urine from the urinary bladder. Baseline urodynamics exams done at screening visit.
Urodynamics:Maximum Detrusor Pressure
Maximum Detrusor Pressure is an urodynamic parameter that is the maximum value of the pressure within the bladder which is measured during the filling phase of the urodynamic exam. Baseline urodynamics exams done at screening visit.
Physician's Global Assessment Score of Treatment Response
The subject's treatment response was assessed by the physician and graded as 'markedly worse', 'much worse', 'worse', 'slightly worse', 'no change', 'slightly improved', 'improved', 'much improved', or 'markedly improved'.
Physician's Global Assessment Score of Treatment Response
The subject's treatment response was assessed by the physician and graded as 'markedly worse', 'much worse', 'worse', 'slightly worse', 'no change', 'slightly improved', 'improved', 'much improved', or 'markedly improved'.
Physician's Global Assessment Score of Treatment Response
The subject's treatment response was assessed by the physician and graded as 'markedly worse', 'much worse', 'worse', 'slightly worse', 'no change', 'slightly improved', 'improved', 'much improved', or 'markedly improved'.
Quality of Life (QoL) Total Summary Score
Mean Change from Baseline in Short Form (SF)-Qualiveen Questionnaire Calculated Total Score. The SF-Qualiveen questionnaire is a specific health related QoL questionnaire validated for urinary disorders in subjects with neurological conditions containing 8 items looking at four scales: limitations (2 items); constraints (2 items); fears (2 items) and feelings (2 items). The 8 items each having a 5-point Likert-type scale ranging from 0="Not at all" to 4="Extremely" for the first 6 items, from 0="Never" to 4="Always" for item 7 and from 0="Always" to 4="Never" for item 8. The score per scale has been calculated as the mean of the two items. In case of one missing item among the 2 items for a given scale, the score has not been calculated. Total score has been calculated as the mean of all the items completed among the 8 items. Lower scores indicate a better QoL (i.e. no limitations, fears, constraints, or negative feelings) and higher scores indicate poorer QoL.
Pain Visual Analogue Scale (VAS) Score: Before Treatment Injection
Pain assessment using the VAS. The VAS is a 100-mm (10-cm) scoring scale. Score range on VAS is from 0 to 100 where zero [0] indicates no pain and 100 indicates worst possible pain.
Pain Visual Analogue Scale (VAS) Score: During Treatment Injection Procedure
Pain assessment using the VAS. The VAS is a 100-mm (10-cm) scoring scale. Score range on VAS is from 0 to 100 where zero [0] indicates no pain and 100 indicates worst possible pain.

Full Information

First Posted
May 17, 2011
Last Updated
September 15, 2022
Sponsor
Ipsen
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1. Study Identification

Unique Protocol Identification Number
NCT01357980
Brief Title
Neurogenic Detrusor Overactivity Following Spinal Cord Injury or Multiple Sclerosis
Official Title
A Phase IIa, Multicentre, Double Blind, Single Dose, Parallel Group, Placebo Controlled, Clinical Pilot Study to Assess the Efficacy and Safety of a Single Dose, Intra-Detrusor Injections of 750 Units of Dysport® in Subjects Suffering From Neurogenic Detrusor Overactivity Following Spinal Cord Injury or Multiple Sclerosis.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine the efficacy and safety of a single dose of 750 U of Dysport compared to placebo for the improvement in the daily incontinence episode frequency for each administration mode in subjects suffering from neurogenic detrusor overactivity following spinal cord injury or multiple sclerosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Detrusor Muscle Hyperactivity
Keywords
Detrusor Muscle Overactivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dysport 750 U (15 injection sites)
Arm Type
Experimental
Arm Title
Placebo (15 injection sites)
Arm Type
Placebo Comparator
Arm Title
Dysport 750 U (30 injection sites)
Arm Type
Experimental
Arm Title
Placebo (30 injection sites)
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
Botulinum toxin type A
Other Intervention Name(s)
AbobotulinumtoxinA (Dysport®)
Intervention Description
750 U intra detrusor injection on Day 1 (single dose)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Intra detrusor injection on Day 1 (single dose)
Primary Outcome Measure Information:
Title
Daily Incontinence Episode Frequency (IEF)
Time Frame
Baseline and Day 84
Secondary Outcome Measure Information:
Title
Urodynamics: Maximum Cystometric Capacity
Description
Maximum Cystometric Capacity is an urodynamic parameter that indicates the volume at which a patient feels he (she) can no longer delay release of urine from the urinary bladder. Baseline urodynamics exams done at screening visit.
Time Frame
Baseline, Days 14, 42 and 84
Title
Urodynamics:Maximum Detrusor Pressure
Description
Maximum Detrusor Pressure is an urodynamic parameter that is the maximum value of the pressure within the bladder which is measured during the filling phase of the urodynamic exam. Baseline urodynamics exams done at screening visit.
Time Frame
Baseline, Days 14, 42 and 84
Title
Physician's Global Assessment Score of Treatment Response
Description
The subject's treatment response was assessed by the physician and graded as 'markedly worse', 'much worse', 'worse', 'slightly worse', 'no change', 'slightly improved', 'improved', 'much improved', or 'markedly improved'.
Time Frame
Day 14
Title
Physician's Global Assessment Score of Treatment Response
Description
The subject's treatment response was assessed by the physician and graded as 'markedly worse', 'much worse', 'worse', 'slightly worse', 'no change', 'slightly improved', 'improved', 'much improved', or 'markedly improved'.
Time Frame
Day 42
Title
Physician's Global Assessment Score of Treatment Response
Description
The subject's treatment response was assessed by the physician and graded as 'markedly worse', 'much worse', 'worse', 'slightly worse', 'no change', 'slightly improved', 'improved', 'much improved', or 'markedly improved'.
Time Frame
Day 84
Title
Quality of Life (QoL) Total Summary Score
Description
Mean Change from Baseline in Short Form (SF)-Qualiveen Questionnaire Calculated Total Score. The SF-Qualiveen questionnaire is a specific health related QoL questionnaire validated for urinary disorders in subjects with neurological conditions containing 8 items looking at four scales: limitations (2 items); constraints (2 items); fears (2 items) and feelings (2 items). The 8 items each having a 5-point Likert-type scale ranging from 0="Not at all" to 4="Extremely" for the first 6 items, from 0="Never" to 4="Always" for item 7 and from 0="Always" to 4="Never" for item 8. The score per scale has been calculated as the mean of the two items. In case of one missing item among the 2 items for a given scale, the score has not been calculated. Total score has been calculated as the mean of all the items completed among the 8 items. Lower scores indicate a better QoL (i.e. no limitations, fears, constraints, or negative feelings) and higher scores indicate poorer QoL.
Time Frame
Baseline, 14, 42 and 84
Title
Pain Visual Analogue Scale (VAS) Score: Before Treatment Injection
Description
Pain assessment using the VAS. The VAS is a 100-mm (10-cm) scoring scale. Score range on VAS is from 0 to 100 where zero [0] indicates no pain and 100 indicates worst possible pain.
Time Frame
Baseline
Title
Pain Visual Analogue Scale (VAS) Score: During Treatment Injection Procedure
Description
Pain assessment using the VAS. The VAS is a 100-mm (10-cm) scoring scale. Score range on VAS is from 0 to 100 where zero [0] indicates no pain and 100 indicates worst possible pain.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject, family member or care giver was willing and able to perform clean intermittent catheterisation (CIC) for the duration of the study Inadequate response or refractory to anticholinergic medication Botulinum Toxin naive for intradetrusor injections and with no previous treatment with Botulinum Toxin of any type, within 3 months prior to study entry for any other condition Have a minimum of 2 incontinences per day calculated as the average daily incontinence episode frequency (IEF) over the 3 days preceding the baseline visit Exclusion Criteria: Significant Baseline renal and/or urinary tract pathology Previous treatment with any endovesical pharmacology agent including detrusor Botulinum Toxin injection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ipsen Study Director
Organizational Affiliation
Ipsen
Official's Role
Study Director
Facility Information:
Facility Name
Faculty Hospital Motol
City
Praha
Country
Czechia
Facility Name
THOMAYER Faculty Hospital
City
Praha
Country
Czechia
Facility Name
Hopital Raymond Poincaré
City
Garches
Country
France
Facility Name
Hopital HURIET
City
Lille
Country
France
Facility Name
Hôpital Lyon Sud -Hospices Civils de Lyon
City
Lyon
Country
France
Facility Name
Hopital de la conception
City
Marseille
Country
France
Facility Name
CHU Hotel Dieu
City
Nantes
Country
France
Facility Name
Groupe Hospitalier La Pitié Salpetriere
City
Paris
Country
France
Facility Name
Hopital Tenon
City
Paris
Country
France
Facility Name
CMRRF Kerpape
City
Ploemeur
Country
France
Facility Name
CHU Rouen - Hopital Charles Nicolle
City
Rouen
Country
France
Facility Name
Nouvel Hopital civil de Strasbourg
City
Strasbourg
Country
France
Facility Name
CHU Toulouse - Hopital Rangueil
City
Toulouse
Country
France
Facility Name
Universitätsklinik Kiel
City
Kiel
Country
Germany
Facility Name
Städtisches Klinikum Neunkirchen
City
Neunkirchen
Country
Germany
Facility Name
Ospedale Careggi
City
Firenze
Country
Italy
Facility Name
NZOZ Centrum Medyczne Mazovia
City
Warszawa
Country
Poland

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/
Citations:
PubMed Identifier
26756554
Citation
Denys P, Del Popolo G, Amarenco G, Karsenty G, Le Berre P, Padrazzi B, Picaut P; Dysport Study Group. Efficacy and safety of two administration modes of an intra-detrusor injection of 750 units dysport(R) (abobotulinumtoxinA) in patients suffering from refractory neurogenic detrusor overactivity (NDO): A randomised placebo-controlled phase IIa study. Neurourol Urodyn. 2017 Feb;36(2):457-462. doi: 10.1002/nau.22954. Epub 2016 Jan 12.
Results Reference
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Neurogenic Detrusor Overactivity Following Spinal Cord Injury or Multiple Sclerosis

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