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

Multiple Sclerosis Clinical Trial

— SANS-REHAB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06314412
• Other study ID #: 24C211
• Status: Recruiting
• Phase: N/A
• Start date: February 13, 2023
• Est. completion date: July 2025

Study information

• Verified date: March 2024
• Source: Istituto Auxologico Italiano
• Contact: Laura Perucca, MD
• Phone: +39 02-619116151
• Email: l.perucca[@]auxologico.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis
• Urinary Incontinence, Urge

Intervention

Other:
• Stoller's Afferent Nerve Stimulation (SANS)
15 sessions of SANS (5 sessions/week for 3 weeks)

Locations

Country	Name	City	State
Italy	Istituto Auxologico Italiano	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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