Testing a nerve stimulator for bladder, bowel, and sexual problems in MS

Plain-English translation of NCT05380856 on ClinicalTrials.gov ↗ · Source last updated July 2026 · Translation generated June 2026 · How we translate trials

This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.

What is this trial?

This trial is testing sacral neuromodulation, a reversible surgical procedure that uses a small implanted device to stimulate nerves in your lower spine. The goal is to help people with multiple sclerosis who are struggling with bladder leakage, bowel problems, or sexual dysfunction despite taking medications. Researchers will compare what happens when the device is turned on versus turned off to see if this treatment can provide real relief.

Many people with MS experience bladder, bowel, and sexual problems that don't improve with standard medications like antimuscarginics or beta-3 agonists. This trial exists to find out whether sacral neuromodulation can offer a new solution for people who haven't had success with these conventional treatments.

Do you qualify?

You likely qualify if…

you have multiple sclerosis with ongoing bladder, bowel, or sexual dysfunction that has not responded well to medications
you currently feel less than 50% satisfied with your current treatment for lower urinary tract problems
you have tried medications (such as antimuscarinics, beta-3 agonists, or alpha-blockers) without adequate improvement
your MS disability level is stable and not rapidly worsening (EDSS score below 5)
you are able to understand the study information and manage electronic devices

You likely don't qualify if…

you have severe MS progression or disability (EDSS score of 5 or higher)
you have had botulinum toxin injections into your bladder within the past 6 months
you have other bladder conditions like interstitial cystitis or bladder pain syndrome
you have a current pelvic cancer or significant pelvic mass
you have had prior pelvic radiation therapy

What participation looks like

If you qualify, you'll undergo a minor surgical procedure to have a small nerve-stimulating device implanted near your sacral nerves. You'll then participate in a 6-month randomized trial where your device will either be turned on (active stimulation) or turned off (no stimulation), and you won't know which group you're in. During the study, you'll track your bladder and bowel symptoms using daily diaries and complete questionnaires about your quality of life. After the 6-month study ends, you'll be followed for up to 5 years with check-ins every 6 months to monitor how you're doing.

AI-generated summary from trial data · Jun 19, 2026 · Not medical advice

Trial locations(1 site)

Denmark

Odense University Hospital, Odense, Fyn