Lower Urinary Tract Symptoms, Multiple Sclerosis
Conditions
Keywords
Multiple sclerosis, Voiding dysfunction, Bladder-sphincter dyssinergia, Tibial neuro-stimulation
Brief summary
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.
Interventions
DEVICEPTNS de verum
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.
DEVICEPTNS placebo
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
Sponsors
University Hospital, Lille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BVE ratio (Bladder Voiding Efficiency) = Ratio of urine volume / total bladder volume | At 12 weeks after randomization | BVE will be measured during the multi-channel urodynamic study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of patients with detrusor overactivity on multi-channel urodynamic study | At 12 weeks after randomization | Detrusor overactivity will be objectify during the multi-channel urodynamic study |
| Post-void residual volume (mL) on multi-channel urodynamic study | At 12 weeks after randomization | Post-void residual volume will be measured during the multi-channel urodynamic study |
| Filling volume (mL) at first detrusor unhibited contraction on multi-channel urodynamic study - If detrusor overactivity. | At 12 weeks after randomization | Filling volume at first detrusor unhibited contraction will be measured during the multi-channel urodynamic study. |
| Maximal detrusor pressure (cmH2O) on multi-channel urodynamic study - If detrusor overactivity. | At 12 weeks after randomization | Maximal detrusor pressure will be measured during the multi-channel urodynamic study |
| Maximal detrusor pressure during micturition (cmH2O) on multi-channel urodynamic study | At 12 weeks after randomization | Maximal detrusor pressure during micturition will be measured during the multi-channel urodynamic study |
| Mean voided volume (mL) on a three-day ambulatory measure | At 12 weeks after randomization | Mean voided volume will be measured using an ambulatory flowmeter (Homeflow®) during three consecutive days |
| Mean maximal flow rate (mL/s) on a three-day ambulatory measure | At 12 weeks after randomization | Mean maximal flow rate will be measured using an ambulatory flowmeter (Homeflow®) during three consecutive days |
| Mean post-void residual volume (mL) on a three-day ambulatory measure | At 12 weeks after randomization | Mean post-void residual volume will be measured using an ambulatory flowmeter (Homeflow®) during three consecutive days. |
| Frequency of patients who were able to stop clean intermittent self-catheterization (PVR < 100 mL) | At 12 weeks after randomization | Mean post-void residual volume will be measured using an ambulatory flowmeter (Homeflow®) during three consecutive days |
| Maximal flow rate (mL/s) on multi-channel urodynamic study | At baseline, At 12 weeks after randomization | Maximal flow rate will be measured during the multi-channel urodynamic study |
| Quality of life self-reported questionnaire (Qualiveen) | At 12 weeks after randomization | Qualiveen |
| Difficulty to perform CISC self-reported questionnaire (ICDQ) | At 12 weeks after randomization | ICDQ : Intermittent Catheterization Difficulty Questionnaire |
| Digestive symptoms self-reported questionnaire (NBD) | At 12 weeks after randomization | NBD : Neurogenic Bowel Dysfunction |
| Digestive symptoms self-reported questionnaire (Wexner) | At 12 weeks after randomization | Wexner questionnaire |
| Sexual symptoms self-reported questionnaire (FSFI) | At 12 weeks after randomization | FSFI (female) : Female Sexual Function Index |
| Sexual symptoms self-reported questionnaire ( MSHQ) | At 12 weeks after randomization | MSHQ (male) : Male Sexual Health Questionnaire |
| Maximal cystomanometric capacity (cmH2O) on multi-channel urodynamic study | At 12 weeks after randomization | Maximal cystomanometric capacity will be measured during the multi-channel urodynamic study |
| Frequency of adverse events occurring during the 12-week follow-up | Measured 12 weeks after randomization | Adverse events will be exhaustively listed |
| Urinary symptoms self-reported questionnaire (USP) | At 12 weeks after randomization | USP : Urinary Symptom Profile |
Countries
France
Contacts
Primary ContactXavier Biardeau, MD
Outcome results
None listed