Neurogenic Detrusor Overactivity Following Spinal Cord Injury or Multiple Sclerosis

Phase 2

Completed

• Conditions: Detrusor Muscle Hyperactivity
• Interventions: Drug: Placebo; Biological: Botulinum toxin type A

• Registration Number: NCT01357980
• Lead Sponsor: Ipsen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-17
• Study First Submitted QC: 2011-05-20
• Study First Posted: 2011-05-23
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Results First Submitted: 2014-03-27
• Results First Submitted QC: 2014-08-21
• Results First Posted: 2014-09-01
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-15
• Last Update Posted: 2022-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo (30 injection sites)	Placebo	-
Dysport 750 U (15 injection sites)	Botulinum toxin type A	-
Placebo (15 injection sites)	Placebo	-
Dysport 750 U (30 injection sites)	Botulinum toxin type A	-

Primary Outcome Measures

Name	Time	Method
Daily Incontinence Episode Frequency (IEF)	Baseline and Day 84

Secondary Outcome Measures

Name	Time	Method
Urodynamics:Maximum Detrusor Pressure	Baseline, Days 14, 42 and 84	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	Day 84	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'.
Pain Visual Analogue Scale (VAS) Score: During Treatment Injection Procedure	Baseline	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.
Urodynamics: Maximum Cystometric Capacity	Baseline, Days 14, 42 and 84	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.
Quality of Life (QoL) Total Summary Score	Baseline, 14, 42 and 84	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	Baseline	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.

Trial Locations

Locations (17)

Hopital Tenon; 🇫🇷 Paris, France

Hôpital Lyon Sud -Hospices Civils de Lyon; 🇫🇷 Lyon, France

NZOZ Centrum Medyczne Mazovia; 🇵🇱 Warszawa, Poland

Städtisches Klinikum Neunkirchen; 🇩🇪 Neunkirchen, Germany

CMRRF Kerpape; 🇫🇷 Ploemeur, France

CHU Toulouse - Hopital Rangueil; 🇫🇷 Toulouse, France

CHU Hotel Dieu; 🇫🇷 Nantes, France

THOMAYER Faculty Hospital; 🇨🇿 Praha, Czechia

Hopital HURIET; 🇫🇷 Lille, France

Hopital de la conception; 🇫🇷 Marseille, France

CHU Rouen - Hopital Charles Nicolle; 🇫🇷 Rouen, France

Groupe Hospitalier La Pitié Salpetriere; 🇫🇷 Paris, France

Universitätsklinik Kiel; 🇩🇪 Kiel, Germany

Faculty Hospital Motol; 🇨🇿 Praha, Czechia

Ospedale Careggi; 🇮🇹 Firenze, Italy

Hopital Raymond Poincaré; 🇫🇷 Garches, France

Nouvel Hopital civil de Strasbourg; 🇫🇷 Strasbourg, France