Multiple SclerosisSANS-REHABNCT06314412
Transcutaneous Posterior Tibial Nerve Stimulation in Patients With Multiple Sclerosis Related Urge Incontinence
A study testing Stoller's Afferent Nerve Stimulation (SANS) in people with Multiple Sclerosis, run by Istituto Auxologico Italiano at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Stoller's Afferent Nerve Stimulation (SANS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 13 Feb 2023to Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
Calogero Malfitano, MD contact
Italy1 site, 1 recruiting
- Recruiting
Istituto Auxologico Italiano
Milan, 20122
Laura Perucca, MD, +3902619116247, l.perucca@auxologico.it
Nicole Bompani, MD, +3902619116151, n.bompani@auxologico.it
About this study
Official title: Perineal Rehabilitation: Efficacy of Transcutaneous Posterior Tibial Nerve Stimulation in Patients With Multiple Sclerosis Related Urge Incontinence
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.
Read the 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
- Being tested
- Stoller's Afferent Nerve Stimulation (SANS)
- Keywords
- Incontinence, Perineum, Stoller's Afferent Nerve Stimulation, Posterior tibial nerve stimulation
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stoller's Afferent Nerve Stimulation (SANS)Other
15 sessions of SANS (5 sessions/week for 3 weeks)
| Study group | Role | What they receive |
|---|---|---|
| Patients with Multiple Sclerosis | Experimental | Patients with Multiple Sclerosis Receives: Other: Stoller's Afferent Nerve Stimulation (SANS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of variation of incontinence.
Evaluated by the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) in the Italian language.
Measured: 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.
Measured: Baseline, at 3 weeks after the start of SANS, at 2 months after the end of SANS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start13 Feb 2023
- Primary completionApr 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Perucca, MD, Principal investigator, Istituto Auxologico Italiano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06314412
- Sponsor's protocol ID
- 24C211
- Acronym
- SANS-REHAB
- Status last verified
- Mar 2024
- First submitted
- 4 Mar 2024
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perineal Rehabilitation: Efficacy of Transcutaneous Posterior Tibial Nerve Stimulation in Patients With Multiple Sclerosis Related Urge Incontinence
- ClinicalTrials.gov ID
- NCT06314412
- Acronym / sponsor ID
- SANS-REHAB / 24C211
- Conditions
- Multiple Sclerosis
- Keywords
- Incontinence, Perineum, Stoller's Afferent Nerve Stimulation, Posterior tibial nerve stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 13 Feb 2023 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 18 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Multiple Sclerosis | Experimental | Other: Stoller's Afferent Nerve Stimulation (SANS)Patients with Multiple Sclerosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stoller's Afferent Nerve Stimulation (SANS)15 sessions of SANS (5 sessions/week for 3 weeks) | Other | Patients with Multiple Sclerosis |
Primary outcome
Measure of variation of incontinence.
Time frame: Baseline, at 3 weeks after the start of SANS, at 2 months after the end of SANS
Evaluated by the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) in the Italian language.
Measure of variation of urinary urgency
Time frame: Baseline, at 3 weeks after the start of SANS, at 2 months after the end of SANS
Evaluated by the Overactive Bladder Questionnaire (OAB-q) in the Italian language.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Calogero Malfitano, MD contact
Laura Perucca, MD principal investigator
Istituto Auxologico Italiano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stoller's Afferent Nerve Stimulation (SANS) in people with Multiple Sclerosis, run by Istituto Auxologico Italiano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laura Perucca, MD (+39 02-619116151, l.perucca@auxologico.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of variation of incontinence. (time frame: Baseline, at 3 weeks after the start of SANS, at 2 months after the end of SANS). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.