Transcutaneous Posterior Tibial Nerve Stimulation in Patients With Multiple Sclerosis Related Urge Incontinence

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-13

Study Completion Date

2025-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patients with Multiple Sclerosis

Group Type EXPERIMENTAL

Stoller's Afferent Nerve Stimulation (SANS)

Intervention Type OTHER

15 sessions of SANS (5 sessions/week for 3 weeks)

Interventions

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Stoller's Afferent Nerve Stimulation (SANS)

15 sessions of SANS (5 sessions/week for 3 weeks)

Intervention Type OTHER

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No