Tests sacral nerve stimulation for bladder problems in multiple sclerosis
Tests a device turned on or off in adults with multiple sclerosis and bladder problems.
Plain-language title generated from the registry record
Registry title: Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction
Key facts
- Where
- Odense, DenmarkSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT05380856, who can take part
Where in Denmark
- Odense University HospitalOdense, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Odense University Hospital
- Trial code
- NCT05380856
- Record updated
- 16 October 2026
- Original description
A multi-center double-blinded placebo-controlled randomized clinical trial.Read full original descriptionShow less
Sacral Neuromodulation for Patients With Multiple Sclerosis With Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction. A Multicenter Double-blind, Placebo-controlled Randomized Clinical Trial.
A multi-center double-blinded placebo-controlled randomized clinical trial.
The patients will be randomized into two groups.
To investigate the efficacy of SNM to improve the key bladder diary variables compared to placebo (i.e. sham) for patients with MS having refractory neurogenic lower urinary tract dysfunction (NLUTD).
After first step SNM-procedure and a 3-4 weeks test period patients with more than 50% improvement in the key bladder diary variables will have the IPG implanted. After a month of optimization patients will into two groups: IPG ON or IPG OFF.
Period of randomization: four months. Number anticipated to be included: 60 patients
Inclusion: 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: Previous pelvis radiotherapy; Bladder injections with botulinum neurotoxin type A within 6 months before inclusion in trial; EDSS > 5, neurological disease with severe progression within the last 6 months and/or unable to manage the electronic devices; Bladder Pain Syndrome/Interstitial cystitis; Current pelvic malignancy or clinically significant pelvic mass; Age < 18 years; Any other urological pathology but nLUTD; Any other intestinal or gynecological pathology but neurological conditional symptoms; Unable to manage the electronic devices; Inability to give an informed consent.