Using sacral neuromodulation to treat urinary, bowel, and sexual dysfunction in patients with multiple sclerosis
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.
This study is testing if a treatment called sacral neuromodulation can help people with multiple sclerosis improve their urinary, bowel, and sexual functions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Odense University Hospital Academic / other |
| Locations | 1 site (Odense, Fyn) |
| Trial ID | NCT05380856 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of sacral neuromodulation (SNM) in improving urinary, bowel, and sexual functions in patients with multiple sclerosis who experience refractory neurogenic lower urinary tract dysfunction. Participants will be randomly assigned to receive either active SNM or a placebo treatment after an initial test period. The study will monitor changes in bladder diary variables, patient-reported outcomes, and safety over a six-month period, with follow-ups extending for five years. The goal is to determine if SNM can significantly enhance quality of life for these patients.
Who should consider this trial
Good fit: Ideal candidates are adults with multiple sclerosis experiencing refractory neurogenic lower urinary tract dysfunction and a satisfaction score of less than 50 on treatment.
Not a fit: Patients with severe neurological disease progression, those with other urological pathologies, or bladder pain syndrome may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide significant relief and improved quality of life for patients suffering from neurogenic dysfunction.
How similar studies have performed: Previous studies have shown promise in using sacral neuromodulation for similar conditions, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Odense, Fyn
- Odense University Hospital — Odense, Fyn, Denmark (Recruiting)
Study contacts
- Principal investigator: Hanne Kobberø — Odense University Hospital
- Study coordinator: Hanne Kobberø
- Email: hanne.kobberoe2@rsyd.dk
- Phone: 004565414400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.