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Nerve zapper may offer relief for MS-related bladder, bowel, and sexual issues — trial puts it to the test

NCT ID NCT05380856

Symptom relief Sponsor: Odense University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time

Summary

This trial tests whether a device called sacral neuromodulation (InterStim X) can improve bladder, bowel, and sexual function in people with multiple sclerosis who have not responded to standard treatments. Participants who show at least 50% improvement during a test period will have the device implanted and then be randomly assigned to have it turned on or off for four months. The goal is to see if the active stimulation leads to better bladder control, fewer leaks, and improved quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sacral neuromodulation (InterStim X system) — a device that sends mild electrical pulses to the sacral nerves to improve bladder, bowel, and sexual function
What this could lead to
If it works, this could offer a new, non-drug option for managing bladder, bowel, and sexual problems in people with multiple sclerosis.
What could go wrong
This is a small, early-stage trial with only 60 participants. The placebo-controlled design means some may not benefit, and device implantation carries surgical risks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2023

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Refractory neurogenic lower urinary tract dysfunction (nLUTD) defined by visual analogue scale on treatment satisfaction ranging from 0 to 100 (100 means maximal satisfaction with the current treatment). All patients indicating satisfaction less than 50 are considered non-responders/having refractory overactive bladder (OAB) to current treatment * No effect of medical treatment defined by antimuscarinics, beta3-agonist and alpha-blocker. * Patients having refractory nLUTD who intend to try SNM for relief of their symptoms * Expanded Disability Status Scale (EDSS) \< 5 and no progression of neurological disease within 6 months * Written informed consent * Able to understand the information given about the project Exclusion Criteria: * EDSS \> 5, neurological disease with severe progression within the last 6 months and/or unable to manage the electronic devices * Age \< 18 years * Any other urological pathology but nLUTD * Bladder Pain Syndrome/Interstitial cystitis * Any other intestinal or gynecological pathology but neurological conditional symptoms * Current pelvic malignancy or clinically significant pelvic mass * Previous pelvis radiotherapy * Bladder injections with botulinum neurotoxin type A within 6 months before inclusion in trial * Unable to manage the electronic devices * Inability to give an informed consent

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Conditions

The condition(s) this trial relates to.

bowel dysfunction intestinal disorder multiple sclerosis physiological sexual disorder Urinary Bladder, Neurogenic

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bowel dysfunction Multiple sclerosis Neurogenic dysfunction of the urinary bladder Quality of life Sacral neuromodulation Sexual dysfunction

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Odense University Hospital

    RECRUITING

    Odense, Fyn, 5000, Denmark

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