Neurogenic Detrusor Overactivity Following Spinal Cord Injury or Multiple Sclerosis

Ipsen47 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Detrusor Muscle Hyperactivity

Interventions

Botulinum toxin type ABIOLOGICAL

750 U intra detrusor injection on Day 1 (single dose)

PlaceboDRUG

Intra detrusor injection on Day 1 (single dose)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (17)

Faculty Hospital Motol

Prague, Czechia

THOMAYER Faculty Hospital

Prague, Czechia

Hopital Raymond Poincaré

Garches, France

Outcomes

Primary Outcomes

Daily Incontinence Episode Frequency (IEF)

Time frame: Baseline and Day 84

Secondary Outcomes

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.

Time frame: Baseline, Days 14, 42 and 84

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.

Time frame: Baseline, Days 14, 42 and 84

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'.

Time frame: Day 14

Physician's Global Assessment Score of Treatment Response

Time frame: Day 42

Physician's Global Assessment Score of Treatment Response

Data from ClinicalTrials.gov

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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.

Time frame: Baseline, 14, 42 and 84