Not provided
Not provided
Not provided
Not provided
Not provided
Substantial amendment to be implemented using another device
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Prevalence of lower urinary tract symptoms (LUTS) in patients with MS increases with disease duration. Current management of urinary clinical symptoms in MS is mainly conservative. Its long-term outcome is often poor because of the progressive disease course and the treatment related side effects. Alternative therapeutic options are botulinum toxin injections, electrical stimulation of dorsal penile/clitoral nerve, and sacral nerve modulation. Posterior tibial nerve stimulation (PTNS) is a second minimally-invasive method of electrical stimulation. Multiple benefits may derive from the development and validation of a dedicated protocol of a new self-activated neuromodulation therapy, which may improve therapy compliance/effectiveness, quality of life and social life in MS patients with refractory LUTS. Furthermore, it may contribute to reduce outpatient visits, health costs and work absenteeism.
To investigate the performance and safety of the medical device eCoinâ„¢ for the treatment of refractory LUTS in patients with MS over a period of 6 months.
This is a prospective, interventional, single arm, self-controlled pilot study in patients with multiple sclerosis and OAB symptoms with a 6-month treatment period of posterior tibial nerve stimulation with the medical device eCoin.
It is a pilot study to explore the effectiveness and safety of using this device to treat MS patients with OAB in daily clinical practice in. Based on feasibility considerations, we plan to include approximately 20 patients.
It consists of:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| eCoin | Experimental | Neuromodulation of posterior tibial nerve |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eCoin | Device | Implantation of device electrodes subcutaneous in lower tibia area; Stimulation of posterior tibial nerves: Regimen 1 (months 0-3): Six stimulation treatments per week, one stimulation per day, for duration of 30 minutes each Regimen 2 (months 3-6): Three stimulation treatments per week, one stimulation per day, for duration of 30 minutes each. Stimulation is activated by the patient. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in bladder volume (mL) | The patients will have their bladder filling volume measured during a urodynamic exam. | Baseline and Week 24 |
| Change from baseline of detrusor pressure amplitude (cmH2O) | The patients will have their detrusor pressure measured during an urodynamic exam. | Baseline and Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline of cystometric capacity (mL) | The patients will have their cystometric capacity measured during an urodynamic exam. | Baseline and Week 24 |
| Change from baseline of bladder compliance (mL/cmH2O) |
Not provided
Main Inclusion Criteria:
Main Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Chiara Zecca, PD, MD | Ospedale Regionale di Lugano | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Regionale di Lugano, Neurocenter of Southern Switzerland | Lugano | Canton Ticino | 6903 | Switzerland |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
The patients will have their bladder compliance assessed during an urodynamic exam.
| Baseline and Week 24 |
| Change from baseline of maximum detrusor pressure (cmH20) during storage phase | The patients will have their maximum detrusor pressure during storage phase measured during an urodynamic exam. | Baseline and Week 24 |
| Change from baseline of maximum detrusor pressure (cmH20) during voiding phase | The patients will have their maximum detrusor pressure during voiding phase measured during an urodynamic exam. | Baseline and Week 24 |
| Change from baseline of voided urine volume (mL) | The patients will have their voided urine volume measured during an urodynamic exam. | Baseline and Week 24 |
| Change from baseline of maximum urine flow rate (mL/s) | The patients will have the maximum urine flow rate measured during an urodynamic exam. | Baseline and Week 24 |
| Change from baseline of post void residual urine (mL) | The patients will have the post void residual urine measured during an urodynamic exam. | Baseline and Week 24 |
| Change from baseline of pelvic floor electromyographic activity | The patients will have presence or absence of pelvic floor activity recorded during an urodynamic exam. | Baseline and Week 24 |
| Change from baseline of vesico-uretero-renal reflux | The patients will have presence or absence of vesico-uretero-renal reflux assessed during an urodynamic exam. | Baseline and Week 24 |
| Change from baseline to 4, 12, and 24 weeks of bladder voiding assessed by means of a 3-day voiding diary | The patients will self-record their bladder voiding during three consecutive days at each time point including the number of voids/day, volume voided/void, number of leaks per day, degree of urgency prior to void (none, mild, moderate, severe, incontinence), number of self-catheterization needed through the day. | Baseline and Week 4, 12, 24 |
| Change from baseline to 4, 12, and 24 weeks of overactive bladder symptoms scores using the short form of the overactive bladder questionnaire OAB-q | The patients will rate their overactive bladder symptoms using the OAB-qSF questionnaire. It is self-administered and asks about how much a patients is bothered by selected bladder symptoms. It contains 6 questions about symptom severity and 13 on coping, sleeping, social life each to be rated on a 6-point scale (none of the time, a little of the time, some of the time, a good bit of the time, most of the time, all of the time). Symptom severity ranges from 6 (not bothered) to 36 (extremely bothered), impact on health related quality of life ranges from 13 (not bothered) to 78 (extremely bothered). | Baseline, Week 4, 12, 24 |
| Change from baseline to 4, 12, and 24 weeks of MSQOL54 scores. | The patients will assess their health related quality of life using the short form of the MSQOL 54 questionnaire. This is a self-administered multidimensional questionnaire on health-related quality of life with generic and multiple sclerosis specific questions on physical and mental health. The summary scores are derived from 12 subscales (physical function, physical role limitations, emotional role limitations, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, sexual function). A low score indicates bad quality of life, a higher score improved quality of life (range 0-100). | Week -8, 4, 12, 24 |
| Treatment satisfaction, as measured on a composite visual analogue scale (VAS) score ranging from 0-100 | The patients will mark a point on a 100 mm long line with a pencil to indicate their treatment satisfaction. 0 (not satisfied at all), 100 (very satisfied). | Week 24 |
| Incidence of adverse events | Number and proportion of patients experiencing device related adverse events during the study period will be recorded. | Week 0, 5, 12, 24 |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |