Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction

Launched by ODENSE UNIVERSITY HOSPITAL · May 15, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Sacral Neuromodulation (SNM) to help people with Multiple Sclerosis (MS) who have ongoing problems with bladder control, bowel function, and sexual health. The goal is to see if SNM can improve these issues better than a placebo (a fake treatment that looks like the real one). Participants will be divided into two groups: one group will receive the actual treatment, while the other will receive the placebo. If patients show significant improvement after an initial trial period with the treatment, they will have a device implanted to help manage their symptoms.

To join the study, participants must be between 18 and 75 years old and have had little to no relief from current medications for their bladder issues. They should also have a certain level of physical ability and be able to give informed consent to participate. During the trial, participants will be monitored for four months to assess how well the treatment works. This trial is important as it aims to improve the quality of life for those struggling with these challenging conditions related to MS.

Gender

ALL

Eligibility 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