Perineal Rehabilitation: Efficacy of Transcutaneous Posterior Tibial Nerve Stimulation in Patients With Multiple Sclerosis Related Urge Incontinence

Status unknownNot a drug-phase studyRelapsing and progressiveNCT06314412

We could not find results for this trial

What it found

No results found

We found no results in the registry or in papers.

What was tested

Treatment tested

  • Stoller's Afferent Nerve Stimulation (SANS)

What it measured

Main measures

  • Measure of variation of incontinence.

    Baseline, at 3 weeks after the start of SANS, at 2 months after the end of SANS

    Bladder, bowel and sexual function
  • Measure of variation of urinary urgency

    Baseline, at 3 weeks after the start of SANS, at 2 months after the end of SANS

    Bladder, bowel and sexual function

Who could take part

Relapsing and progressive · 18 and over · EDSS 2 to 6.5

Show the full criteria

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;

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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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History

    1. Started

      Feb 2023

    2. Main results due

      Apr 2025

    3. Finished

      Jul 2025

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