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Recently, several studies have investigated the safety and efficacy of the Stoller afferent nerve stimulation (SANS) treatment in Multiple Sclerosis (MS) patients. However, because of the differences among the published protocols (percutaneous versus transcutaneous stimulation, stimulation site, total number of sessions), and the absence of data on the duration of the effect, this treatment is not yet currently included in the rehabilitation programs. The present study aims at evaluating the efficacy of a protocol of SANS in the short- and medium-term follow-up.
The efficacy of the proposed stimulation protocol on the physiological parameters of bladder function will be also investigated.
The primary outcome will be the variation of urinary urgency and incontinence. It will be evaluated by self-reported measuring scales, such as the Overactive Bladder Questionnaire (OAB-q) and the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) in their Italian forms.
The expected outcome is that the treatment of posterior tibial nerve stimulation will reduce the frequency and the urgency of urination, and urinary incontinence. Moreover, results from the follow-up will allow estimating the duration of the expected outcome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Multiple Sclerosis | Experimental | Patients with Multiple Sclerosis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stoller's Afferent Nerve Stimulation (SANS) | Other | 15 sessions of SANS (5 sessions/week for 3 weeks) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measure of variation of incontinence. | Evaluated by the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) in the Italian language. | Baseline, at 3 weeks after the start of SANS, at 2 months after the end of SANS |
| Measure of variation of urinary urgency | Evaluated by the Overactive Bladder Questionnaire (OAB-q) in the Italian language. | Baseline, at 3 weeks after the start of SANS, at 2 months after the end of SANS |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laura Perucca, MD | Contact | +39 02-619116151 | l.perucca@auxologico.it | |
| Calogero Malfitano, MD | Contact | calogero.malfitano@unimi.it |
| Name | Affiliation | Role |
|---|---|---|
| Laura Perucca, MD | Istituto Auxologico Italiano | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Auxologico Italiano | Recruiting | Milan | 20122 | Italy |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| 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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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |