NCT06314412

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Istituto Auxologico Italiano · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
OTHER	Stoller's Afferent Nerve Stimulation (SANS)	15 sessions of SANS (5 sessions/week for 3 weeks)

Timeline

• Start date: 2023-02-13
• Primary completion: 2025-04-01
• Completion: 2025-07-01
• First posted: 2024-03-18
• Last updated: 2024-03-18

Locations

1 site across 1 country: Italy