Nerve stimulation for bladder control in multiple sclerosis patients
Perineal Rehabilitation: Efficacy of Transcutaneous Posterior Tibial Nerve Stimulation in Patients With Multiple Sclerosis Related Urge Incontinence
This study is testing a new nerve stimulation treatment to see if it can help people with multiple sclerosis who have trouble controlling their bladder.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Istituto Auxologico Italiano Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT06314412 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy of Stoller's Afferent Nerve Stimulation (SANS) in patients with multiple sclerosis who experience urge incontinence. It aims to assess the impact of this treatment on urinary urgency and incontinence through self-reported questionnaires. The study will follow participants over a short- and medium-term period to determine the effectiveness and duration of the treatment's benefits. The results will contribute to understanding how this protocol can be integrated into rehabilitation programs for MS patients.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with multiple sclerosis who have an Expanded Disability Status Scale (EDSS) score between 2 and 6.5.
Not a fit: Patients with EDSS scores of 7 or higher, recent MS relapses, or other significant medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve bladder control and quality of life for patients with multiple sclerosis.
How similar studies have performed: Previous studies have shown promise in using nerve stimulation for similar conditions, but this specific approach is still being evaluated for its efficacy in MS patients.
Eligibility criteria
Show full inclusion / exclusion 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;
Where this trial is running
Milan
- Istituto Auxologico Italiano — Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Laura Perucca, MD — Istituto Auxologico Italiano
- Study coordinator: Laura Perucca, MD
- Email: l.perucca@auxologico.it
- Phone: +39 02-619116151
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.