Hop Claude Huriez Chu Lille
Lille, 59037, France
Location status: Recruiting
Location contact
CONTACT
NCT Number: NCT04573673
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Lille, 59037, France
Location status: Recruiting
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patient with one or more bladder diverticulum(s) Patient with unilateral or bilateral renal Patient with unilateral or bilateral vesico-ureteral reflux Patient with impaired renal function (GFR according to CKD-EPI < 60 ml/min/1.73m2) Patient with a metallic prosthesis on the lower limb Patient with a Pacemaker Pregnant patient
The 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.
Other names: Peristim Pro (CEFAR-COMPEX®)
The 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
Other names: Peristim Pro (CEFAR-COMPEX®
Time frame: At 12 weeks after randomization
BVE will be measured during the multi-channel urodynamic study
Time frame: At baseline, At 12 weeks after randomization
Maximal flow rate will be measured during the multi-channel urodynamic study
Time frame: At 12 weeks after randomization
Post-void residual volume will be measured during the multi-channel urodynamic study
Time frame: At 12 weeks after randomization
Maximal detrusor pressure during micturition will be measured during the multi-channel urodynamic study
Time frame: At 12 weeks after randomization
Mean voided volume will be measured using an ambulatory flowmeter (Homeflow®) during three consecutive days
Time frame: At 12 weeks after randomization
Mean maximal flow rate will be measured using an ambulatory flowmeter (Homeflow®) during three consecutive days
Time frame: At 12 weeks after randomization
Mean post-void residual volume will be measured using an ambulatory flowmeter (Homeflow®) during three consecutive days.
Time frame: At 12 weeks after randomization
Mean post-void residual volume will be measured using an ambulatory flowmeter (Homeflow®) during three consecutive days
Time frame: At 12 weeks after randomization
USP : Urinary Symptom Profile
Time frame: At 12 weeks after randomization
Qualiveen
Time frame: At 12 weeks after randomization
ICDQ : Intermittent Catheterization Difficulty Questionnaire
Time frame: At 12 weeks after randomization
NBD : Neurogenic Bowel Dysfunction
Time frame: At 12 weeks after randomization
Wexner questionnaire
Time frame: At 12 weeks after randomization
FSFI (female) : Female Sexual Function Index
Time frame: At 12 weeks after randomization
MSHQ (male) : Male Sexual Health Questionnaire
Time frame: At 12 weeks after randomization
Detrusor overactivity will be objectify during the multi-channel urodynamic study
Time frame: At 12 weeks after randomization
Filling volume at first detrusor unhibited contraction will be measured during the multi-channel urodynamic study.
Time frame: At 12 weeks after randomization
Maximal detrusor pressure will be measured during the multi-channel urodynamic study
Time frame: At 12 weeks after randomization
Maximal cystomanometric capacity will be measured during the multi-channel urodynamic study
Time frame: Measured 12 weeks after randomization
Adverse events will be exhaustively listed
Contact information is provided by the study sponsor or research team.
University Hospital, Lille
Other
Efficacy and Safety of Transcutaneous Tibial Neuro-stimulation to Improve Voiding Dysfunction in Multiple Sclerosis Patients.
Acronym: NEUROSTIM-SEP1
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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