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

NCT06314412 | Recruiting

• 1 other identifier: 24C211
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Incontinence; Perineum; Stoller's Afferent Nerve Stimulation; Posterior tibial nerve stimulation

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Patients with Multiple Sclerosis

EXPERIMENTAL

Patients with Multiple Sclerosis

Other: Stoller's Afferent Nerve Stimulation (SANS)

Interventions

Stoller's Afferent Nerve Stimulation (SANS) OTHER

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

Patients with Multiple Sclerosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

Study Sites (1)

Istituto Auxologico Italiano

Milan, 20122, Italy

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Laura Perucca, MD

  Istituto Auxologico Italiano

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Perucca, MD

CONTACT

+39 02-619116151; l.perucca@auxologico.it

Calogero Malfitano, MD

CONTACT

calogero.malfitano@unimi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 18, 2024
• Study Start: February 13, 2023
• Primary Completion: April 1, 2025
• Study Completion: July 1, 2025
• Last Updated: March 18, 2024

Record last verified: 2024-03

Locations

IT (1)