NCT05380856Recruiting
Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction
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.
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 22 Dec 2021
- Start date
- 18 Aug 2023
- Primary completion date
- 1 Sept 2027
- Lead sponsor
- Odense University Hospital
- Diseases
- Multiple sclerosis
- NCT number
- NCT05380856
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 18 Aug 2023 to the primary completion date, 1 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous pelvis radiotherapy
- Bladder injections with botulinum neurotoxin type A within 6 months before inclusion in trial
Other illness
- 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
- Age \< 18 years
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Odense University Hospital Coordinator of this site? Confirm its status | Odense | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.