Using sacral neuromodulation to treat urinary, bowel, and sexual dysfunction in patients with multiple sclerosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.