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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-A03045-50 | Other Identifier | ID-RCB number, ANSM |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PTNS verum | Experimental | Patients will be treated with transcutaneous tibial neuro-stimulation with one 30-minute session daily for a period of 12 weeks. |
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| PTNS placebo | Sham Comparator | Patients will be treated with placebo (i.e. no current) transcutaneous tibial neuro-stimulation for 30 consecutive minutes daily for 12 weeks (same treatment regimen as the experimental group). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PTNS de verum | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| BVE ratio (Bladder Voiding Efficiency) = Ratio of urine volume / total bladder volume | BVE will be measured during the multi-channel urodynamic study | At 12 weeks after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Maximal flow rate (mL/s) on multi-channel urodynamic study | Maximal flow rate will be measured during the multi-channel urodynamic study | At baseline, At 12 weeks after randomization |
| Post-void residual volume (mL) on multi-channel urodynamic study |
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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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xavier Biardeau, MD | Contact | 03.20.44.41.73 | +33 | xavier.biardeau@chru-lille.fr |
| Name | Affiliation | Role |
|---|---|---|
| Xavier Biardeau, MD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hop Claude Huriez Chu Lille | Recruiting | Lille | 59037 | France |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D059411 | Lower Urinary Tract Symptoms |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| PTNS placebo | Device | 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 |
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Post-void residual volume will be measured during the multi-channel urodynamic study
| At 12 weeks after randomization |
| 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 | At 12 weeks after randomization |
| 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 | At 12 weeks after randomization |
| Mean maximal flow rate (mL/s) on a three-day ambulatory measure | Mean maximal flow rate will be measured using an ambulatory flowmeter (Homeflow®) during three consecutive days | At 12 weeks after randomization |
| Mean post-void residual volume (mL) on a three-day ambulatory measure | Mean post-void residual volume will be measured using an ambulatory flowmeter (Homeflow®) during three consecutive days. | At 12 weeks after randomization |
| Frequency of patients who were able to stop clean intermittent self-catheterization (PVR < 100 mL) | Mean post-void residual volume will be measured using an ambulatory flowmeter (Homeflow®) during three consecutive days | At 12 weeks after randomization |
| Urinary symptoms self-reported questionnaire (USP) | USP : Urinary Symptom Profile | At 12 weeks after randomization |
| Quality of life self-reported questionnaire (Qualiveen) | Qualiveen | At 12 weeks after randomization |
| Difficulty to perform CISC self-reported questionnaire (ICDQ) | ICDQ : Intermittent Catheterization Difficulty Questionnaire | At 12 weeks after randomization |
| Digestive symptoms self-reported questionnaire (NBD) | NBD : Neurogenic Bowel Dysfunction | At 12 weeks after randomization |
| Digestive symptoms self-reported questionnaire (Wexner) | Wexner questionnaire | At 12 weeks after randomization |
| Sexual symptoms self-reported questionnaire (FSFI) | FSFI (female) : Female Sexual Function Index | At 12 weeks after randomization |
| Sexual symptoms self-reported questionnaire ( MSHQ) | MSHQ (male) : Male Sexual Health Questionnaire | At 12 weeks after randomization |
| Frequency of patients with detrusor overactivity on multi-channel urodynamic study | Detrusor overactivity will be objectify during the multi-channel urodynamic study | At 12 weeks after randomization |
| Filling volume (mL) at first detrusor unhibited contraction on multi-channel urodynamic study - If detrusor overactivity. | Filling volume at first detrusor unhibited contraction will be measured during the multi-channel urodynamic study. | At 12 weeks after randomization |
| Maximal detrusor pressure (cmH2O) on multi-channel urodynamic study - If detrusor overactivity. | Maximal detrusor pressure will be measured during the multi-channel urodynamic study | At 12 weeks after randomization |
| Maximal cystomanometric capacity (cmH2O) on multi-channel urodynamic study | Maximal cystomanometric capacity will be measured during the multi-channel urodynamic study | At 12 weeks after randomization |
| Frequency of adverse events occurring during the 12-week follow-up | Adverse events will be exhaustively listed | Measured 12 weeks after randomization |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |