Multiple Sclerosis
Conditions
Keywords
Incontinence, Perineum, Stoller's Afferent Nerve Stimulation, Posterior tibial nerve stimulation
Brief summary
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.
Detailed description
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.
Interventions
OTHERStoller's Afferent Nerve Stimulation (SANS)
15 sessions of SANS (5 sessions/week for 3 weeks)
Sponsors
Istituto Auxologico Italiano
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* MS diagnosis according to the revised McDonalds criteria. Relapsing-remitting, primary and secondary progressive MS forms are allowed; * Expanded Disability Status Scale (EDSS) between 2 and 6.5 included; * MiniMental State Examination ≥ cut off 24/84 by sex/age
Exclusion criteria
* Any of the following in the month before enrolment: an MS relapse; current corticosteroids therapy because of MS; change in medicines prescribed against fatigue; attending an intensive physical therapy program; * New or active lesions on a brain or spinal cord MRI scan in the 12 months before the study enrolment; * Any musculoskeletal disease or any additional neurological disorder * Urinary infections or surgery in perineal regions * Skin lesions or carcinoma in situ * Pregnancy * Expanded Disability Status Scale (EDSS) ≥ 7;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure of variation of incontinence. | Baseline, at 3 weeks after the start of SANS, at 2 months after the end of SANS | Evaluated by the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) in the Italian language. |
| Measure of variation of urinary urgency | Baseline, at 3 weeks after the start of SANS, at 2 months after the end of SANS | Evaluated by the Overactive Bladder Questionnaire (OAB-q) in the Italian language. |
Countries
Italy
Contacts
Primary ContactLaura Perucca, MD
Backup ContactCalogero Malfitano, MD
Outcome results
None listed