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Neurogenic Detrusor Overactivity Following Spinal Cord Injury or Multiple Sclerosis

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.
CompletedPhase 2MS (type not specified)NCT013579802010-023210-31

What it found

Missed its main goal

The main measure did not show a significant benefit.

MeasureEstimate95% CIp
Daily Incontinence Episode Frequency (IEF)Mean Treatment Difference -0.61-1.27–0.050.07
Daily Incontinence Episode Frequency (IEF)Mean Treatment Difference -1.54-3.47–0.390.11

Statistical analysis as posted on ClinicalTrials.gov.

What was tested

Treatment tested

  • Botulinum toxin type a

    Synaptosomal nerve-associated protein 25 (SNAP-25) hydrolytic enzyme

  • Onabotulinumtoxina

    Synaptosomal nerve-associated protein 25 (SNAP-25) inhibitor

Placebo or sham

  • Placebo

Results by group

Daily Incontinence Episode Frequency (IEF)

Baseline and Day 84

GroupValueIntervalNumber analysed
Dysport 750 U (15 Injection Sites)4.21 episodes per day2.32 (Standard Deviation)14
Placebo (15 Injection Sites)3.33 episodes per day2.87 (Standard Deviation)6
Dysport 750 U (30 Injection Sites)3.23 episodes per day1.26 (Standard Deviation)16
Placebo (30 Injection Sites)4.40 episodes per day1.55 (Standard Deviation)6
Dysport 750 U (15 Injection Sites)-3.51 episodes per day2.8 (Standard Deviation)14
Placebo (15 Injection Sites)-1.05 episodes per day2.95 (Standard Deviation)6
Dysport 750 U (30 Injection Sites)-2.86 episodes per day1.43 (Standard Deviation)16
Placebo (30 Injection Sites)-3.40 episodes per day1.49 (Standard Deviation)6

p = 0.11; Mean Treatment Difference -1.54 (95% CI -3.47–0.39)

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Dysport 750 U (15 Injection Sites)165 (31.3%)
Placebo (15 Injection Sites)70 (0.0%)
Dysport 750 U (30 Injection Sites)171 (5.9%)
Placebo (30 Injection Sites)70 (0.0%)

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Daily Incontinence Episode Frequency (IEF)

    Baseline and Day 84

    Bladder, bowel and sexual function

  • Mean change from baseline in the averaged daily frequency of episodes of urinary incontinence (calculated as the average daily IEF over the 3 days preceding each visit).

    Bladder, bowel and sexual function

Other measures (9)

  • Urodynamics: Maximum Cystometric Capacity

    Baseline, Days 14, 42 and 84

    Bladder, bowel and sexual function

  • Urodynamics:Maximum Detrusor Pressure

    Baseline, Days 14, 42 and 84

    Bladder, bowel and sexual function

  • Physician's Global Assessment Score of Treatment Response

    Day 14

  • Physician's Global Assessment Score of Treatment Response

    Day 42

  • Physician's Global Assessment Score of Treatment Response

    Day 84

  • Quality of Life (QoL) Total Summary Score

    Baseline, 14, 42 and 84

    Bladder, bowel and sexual functionQuality of life (reported by participants)

  • Pain Visual Analogue Scale (VAS) Score: Before Treatment Injection

    Baseline

    Pain

  • Pain Visual Analogue Scale (VAS) Score: During Treatment Injection Procedure

    Baseline

    Pain

  • - Urodynamic examination: manocystometric measurements.

Who could take part

MS (type not specified) · 18 to 70

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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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History

    1. Started

      May 2011

    2. Main results due

      Mar 2013

    3. Finished

      Mar 2013

    4. Results posted

      Sept 2014

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