Transcutaneous Tibial Neuro-stimulation to Improve Voiding Dysfunction in Multiple Sclerosis.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity Hospital, Lille
About this trial
The present trial is designed to assess the efficacy and safety of transcutaneous tibial neuro-stimulation (TTNS) in improving bladder emptying in multiple sclerosis (MS) patients.
Patients presenting with MS and performing clean intermittent self-catheterization (CISC) to empty the bladder in the context of voiding dysfunction, will be eligible.
Included patients will be randomly assigned to two distinct arms
* PTNS de verum : patients will be treated with transcutaneous tibial neuro-stimulation at a rate of one session of 30 consecutive minutes daily for a period of 12 weeks. * PTNS placebo : Patients will be treated with placebo (i.e. no current) transcutaneous tibial neuro-stimulation for 30 consecutive minutes daily for a period of 12 weeks (same treatment regimen as the experimental group).
Efficacy in improving voiding dysfunction will be assessed 12 weeks after randomization using the BVE ratio (Bladder Voiding Efficiency) = Ratio of urine volume / total bladder volume.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient with a diagnosis of multiple sclerosis
Patient with bladder-sphincter dyssinergia
Patient using clean intermittent self-catheterization as exclusive bladder management
Patient who has given written consent
Disqualifiers
Patient with other associated neurological pathology
Patient with an Expanded Disability Status Scale (EDSS) score ≥ 6
Patient with recurrent urinary tract infections (> 3 episodes / year)
Patient with uncontrolled overactive bladder
Trial design
Design model
Parallel
Treatments tested in this trial
PTNS de verum
DeviceThe device will be set to program P-4: Frequency 20Htz, Pulse duration = 200 µs. The amplitude (Volt) will be adjusted by the patient according to the feeling.
PTNS placebo
DeviceThe device will be set to program P-4: Frequency 20Htz, Pulse duration = 200 µs. A resistor will be incorporated in the device to block the passage of electric current
Treatment groups
68 Participants
are divided into 2 treatment groupsGroup A: PTNS verumExperimental treatment 1 intervention
Group B: PTNS placeboSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
BVE ratio (Bladder Voiding Efficiency) = Ratio of urine volume / total bladder volume
BVE will be measured during the multi-channel urodynamic study
Time frame
At 12 weeks after randomizationSecondary outcomes
1
Maximal flow rate (mL/s) on multi-channel urodynamic study
Maximal flow rate will be measured during the multi-channel urodynamic study
Time frame
At baseline, At 12 weeks after randomization2
Post-void residual volume (mL) on multi-channel urodynamic study
Post-void residual volume will be measured during the multi-channel urodynamic study
Time frame
At 12 weeks after randomization3
Maximal detrusor pressure during micturition (cmH2O) on multi-channel urodynamic study
Maximal detrusor pressure during micturition will be measured during the multi-channel urodynamic study
Time frame
At 12 weeks after randomization4
Mean voided volume (mL) on a three-day ambulatory measure
Mean voided volume will be measured using an ambulatory flowmeter (Homeflow®) during three consecutive days
Time frame
At 12 weeks after randomizationSponsors and contacts
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Source ClinicalTrials.gov