Clinical trial NCT01357980: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Detrusor Muscle Hyperactivity
Keywords: Detrusor Muscle Overactivity
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2011-05-23
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
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 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.


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

Primary outcomes:
measure: Daily Incontinence Episode Frequency (IEF)
timeFrame: Baseline and Day 84
Secondary outcomes:
measure: Urodynamics: Maximum Cystometric Capacity
timeFrame: Baseline, Days 14, 42 and 84
measure: Urodynamics:Maximum Detrusor Pressure
timeFrame: Baseline, Days 14, 42 and 84
measure: Physician's Global Assessment Score of Treatment Response
timeFrame: Day 14
measure: Physician's Global Assessment Score of Treatment Response
timeFrame: Day 42
measure: Physician's Global Assessment Score of Treatment Response
timeFrame: Day 84
measure: Quality of Life (QoL) Total Summary Score
timeFrame: Baseline, 14, 42 and 84
measure: Pain Visual Analogue Scale (VAS) Score: Before Treatment Injection
timeFrame: Baseline
measure: Pain Visual Analogue Scale (VAS) Score: During Treatment Injection Procedure
timeFrame: Baseline
Other outcomes:
Locations:
city: Praha
country: Czechia
facility: Faculty Hospital Motol
city: Praha
country: Czechia
facility: THOMAYER Faculty Hospital
city: Garches
country: France
facility: Hopital Raymond Poincaré
city: Lille
country: France
facility: Hopital HURIET
city: Lyon
country: France
facility: Hôpital Lyon Sud -Hospices Civils de Lyon
city: Marseille
country: France
facility: Hopital de la conception
city: Nantes
country: France
facility: CHU Hotel Dieu
city: Paris
country: France
facility: Groupe Hospitalier La Pitié Salpetriere
city: Paris
country: France
facility: Hopital Tenon
city: Ploemeur
country: France
facility: CMRRF Kerpape
city: Rouen
country: France
facility: CHU Rouen - Hopital Charles Nicolle
city: Strasbourg
country: France
facility: Nouvel Hopital civil de Strasbourg
city: Toulouse
country: France
facility: CHU Toulouse - Hopital Rangueil
city: Kiel
country: Germany
facility: Universitätsklinik Kiel
city: Neunkirchen
country: Germany
facility: Städtisches Klinikum Neunkirchen
city: Firenze
country: Italy
facility: Ospedale Careggi
city: Warszawa
country: Poland
facility: NZOZ Centrum Medyczne Mazovia
Study officials:
affiliation: Ipsen
name: Ipsen Study Director
role: STUDY_DIRECTOR
References:
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.