Transcutaneous Tibial Neuro-stimulation to Improve Voiding Dysfunction
Efficacy and Safety of Transcutaneous Tibial Neuro-stimulation to Improve Voiding Dysfunction in Multiple Sclerosis Patients.
What it found
No result yet.
What was tested
Treatment tested
- PTNS de verum
Placebo
- PTNS placebo
What it measured
Main measures
BVE ratio (Bladder Voiding Efficiency) = Ratio of urine volume / total bladder volume
At 12 weeks after randomization
Bladder, bowel and sexual function
Other measures (19)
Maximal flow rate (mL/s) on multi-channel urodynamic study
At baseline, At 12 weeks after randomization
Post-void residual volume (mL) on multi-channel urodynamic study
At 12 weeks after randomization
Bladder, bowel and sexual functionMaximal detrusor pressure during micturition (cmH2O) on multi-channel urodynamic study
At 12 weeks after randomization
Mean voided volume (mL) on a three-day ambulatory measure
At 12 weeks after randomization
Bladder, bowel and sexual functionMean maximal flow rate (mL/s) on a three-day ambulatory measure
At 12 weeks after randomization
Mean post-void residual volume (mL) on a three-day ambulatory measure
At 12 weeks after randomization
Bladder, bowel and sexual functionFrequency of patients who were able to stop clean intermittent self-catheterization (PVR < 100 mL)
At 12 weeks after randomization
Bladder, bowel and sexual functionUrinary symptoms self-reported questionnaire (USP)
At 12 weeks after randomization
Bladder, bowel and sexual functionQuality of life self-reported questionnaire (Qualiveen)
At 12 weeks after randomization
Quality of life (reported by participants)Difficulty to perform CISC self-reported questionnaire (ICDQ)
At 12 weeks after randomization
Who could take part
MS (type not specified) · 18 to 65
Show the full criteria
Inclusion criteria
* 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 * Socially insured patient * Patient willing to comply with all study procedures and study duration
Exclusion criteria
* 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 * Patient with uncontrolled detrusor hyperactivity * Patient with a bladder compliance disorder * Patient with tibial neuro-stimulation in the last 3 months * Patient treated with a sacral neuro-modulation * Patient who has received an intradermal injection of botulinum toxin A within the last 9 -months Patient who received alpha-blocker treatment within the last month Patient with benign prostatic hypertrophy (prostate volume > 40 cc) - Last ultrasound scan \< 6 months. 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
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
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.
Loading reviews and guidelines…
History
Started
Dec 2021
Main results due
Jun 2026
Finished
Jun 2026