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Central Nervous System Changes Following OnabotulinumtoxinA Injection in the Bladder

A Prospective Study of Higher Neural Control Changes Following Intra-detrusor Injection of Onabotulinumtoxin-A in Patients With Multiple Sclerosis and Lower Urinary Tract Symptoms.
CompletedMS (type not specified)NCT03033355

What it found

Met its main goal

The main measure showed a statistically significant benefit.

MeasureEstimate95% CIp
Change in Blood Oxygen Level Dependent (BOLD) Signals in the Brain After Treatment 0.001
Change in Blood Oxygen Level Dependent (BOLD) Signals in the Brain After Treatment 0.0012
Change in Blood Oxygen Level Dependent (BOLD) Signals in the Brain After Treatment 0.0015
Change in Blood Oxygen Level Dependent (BOLD) Signals in the Brain After Treatment 0.0015
Change in Blood Oxygen Level Dependent (BOLD) Signals in the Brain After Treatment 0.0138
Change in Blood Oxygen Level Dependent (BOLD) Signals in the Brain After Treatment 0.015
Change in Blood Oxygen Level Dependent (BOLD) Signals in the Brain After Treatment 0.02
Change in Blood Oxygen Level Dependent (BOLD) Signals in the Brain After Treatment 0.026
Change in Blood Oxygen Level Dependent (BOLD) Signals in the Brain After Treatment 0.026
Change in Blood Oxygen Level Dependent (BOLD) Signals in the Brain After Treatment 0.049

Statistical analysis as posted on ClinicalTrials.gov.

What was tested

Treatment tested

Results by group

Change in Blood Oxygen Level Dependent (BOLD) Signals in the Brain After Treatment

Baseline (pre-OnabotA) and 6-10 weeks post-OnabotA treatment

GroupValueIntervalNumber analysed
Pre and Post BTX-A Injection2.6 BOLD Signal Change Derived T-Value-3.9–3.512
Pre and Post BTX-A Injection2.6 BOLD Signal Change Derived T-Value-3.9–3.512
Pre and Post BTX-A Injection3.5 BOLD Signal Change Derived T-Value-3.9–3.512
Pre and Post BTX-A Injection2.6 BOLD Signal Change Derived T-Value-3.9–3.512
Pre and Post BTX-A Injection2.6 BOLD Signal Change Derived T-Value-3.9–3.512
Pre and Post BTX-A Injection2.4 BOLD Signal Change Derived T-Value-3.9–3.512
Pre and Post BTX-A Injection-3.9 BOLD Signal Change Derived T-Value-3.9–3.512
Pre and Post BTX-A Injection-3.1 BOLD Signal Change Derived T-Value-3.9–3.512
Pre and Post BTX-A Injection-2.1 BOLD Signal Change Derived T-Value-3.9–3.512
Pre and Post BTX-A Injection-2.6 BOLD Signal Change Derived T-Value-3.9–3.512
Pre and Post BTX-A Injection-2.0 BOLD Signal Change Derived T-Value-3.9–3.512

p = 0.0012

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

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Pre and Post BTX-A Injection120 (0.0%)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

  • Change in Blood Oxygen Level Dependent (BOLD) Signals in the Brain After Treatment

    Baseline (pre-OnabotA) and 6-10 weeks post-OnabotA treatment

    MRI lesionsNerve conduction testsBladder, bowel and sexual function

Other measures (6)

  • Changes in Urodynamic (UDS) Parameters Following OnabotA Treatment

    Baseline (Pre-OnabotA) and 6-10 Weeks Post-OnabotA Treatment

    MRI lesionsNerve conduction testsBladder, bowel and sexual function

  • Number of Participants Presenting With Neurogenic Detrusor Overactivity (NDO) Events During Urodynamic Studies (UDS) Before and After OnabotA Treatment

    Baseline (Pre-OnabotA) and 6-10 Weeks Post-OnabotA Treatment

    Nerve conduction testsBladder, bowel and sexual function

  • Changes in Subjective Clinical Outcomes Following Treatment - Urogenital Distress Inventory, Short Form (UDI-6)

    Baseline (Pre-OnabotA) and 6-10 Weeks Post-OnabotA Treatment

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

  • Changes in Subjective Clinical Outcomes Following Treatment - Incontinence Impact Questionnaire Short Form (IIQ-7)

    Baseline (Pre-OnabotA) and 6-10 Weeks Post-OnabotA Treatment

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

  • Changes in Voiding Diary Metrics - Urge Urinary Incontinence (UUI) Events Per Day

    Baseline (Pre-OnabotA) and 6-10 Weeks Post-OnabotA Treatment

    Bladder, bowel and sexual function

  • Changes in Voiding Diary Metrics - Number of Participants Requiring Clean Intermittent Catheterization(CIC)

    Baseline (Pre-OnabotA) and 6-10 Weeks Post-OnabotA Treatment

    Bladder, bowel and sexual function

Who could take part

MS (type not specified) · 18 and over

Inclusion Criteria: * Patients with clinical diagnosis of neurogenic bladder. * History of any neurologic illness or injury (including but not limited to spinal cord injury, Multiple Sclerosis, spina bifida, Parkinson's, major spine surgery). * 18 years or older. * Female patients. Exclusion Criteria: * Male * History of any incontinence surgery (sling, Marshall-Marchetti-Krantz Procedure, Burch). * History of any lower urinary tract surgery or manipulation (urethral dilation). * Positive urine pregnancy test at enrollment .

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 research study is to evaluate higher neural changes following intra-detrusor injection of Onabotulinumtoxin-A (BTX-A) in patients with Multiple Sclerosis (MS). We will use our prospectively collected cohort of patients. Concurrent Urodynamic and Functional Magnetic Resonance (fMRI) data will be recorded pre- and post-intravesical injection of BTX-A in patients with Multiple Sclerosis (MS) and neurogenic detrusor activity (NDO).

Papers

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    History

      1. Started

        Feb 2014

      2. Main results due

        Mar 2019

      3. Finished

        Mar 2019

      4. Results posted

        Aug 2025

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