RecruitingNot ApplicableNCT05380856

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.


Sponsor

Odense University Hospital

Enrollment

60 participants

Start Date

Sep 26, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a treatment called sacral neuromodulation (SNM) — a small implanted device that sends gentle electrical signals to nerves in the lower spine — can improve bladder, bowel, and sexual function in people with neurological conditions (such as multiple sclerosis or spinal cord injury). **You may be eligible if...** - You have neurogenic bladder dysfunction (bladder problems caused by a neurological condition) that has not responded to medications - Your condition is relatively stable (disability score below 5 on the EDSS scale, no progression in the past 6 months) - You are unhappy with your current treatment (satisfaction score below 50 out of 100) - You are willing to try neuromodulation therapy **You may NOT be eligible if...** - Your neurological disability is severe (EDSS above 5) - Your neurological condition is currently worsening or progressing - You have already tried and benefited from current drug treatments Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETurning ON the neuromodulator

IPG on

DEVICETurning OFF the neuromodulator

IPG OFF


Locations(1)

Odense University Hospital

Odense, Fyn, Denmark

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NCT05380856


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