Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction in Patients With Multiple Sclerosis: A Pilot Trial.
Hanne Kobberø, Jan Krhut, Peter Zvara...
https://pubmed.ncbi.nlm.nih.gov/40223778Actively Recruiting
Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID05380856
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
Led by Odense University Hospital · Updated on 2025-03-20
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
O
Odense University Hospital
Lead Sponsor
U
University of Copenhagen
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating sacral neuromodulation (SNM) to improve bladder, bowel, and sexual function in patients with multiple sclerosis (MS) who have refractory neurogenic lower urinary tract dysfunction (NLUTD). This multi-center, double-blinded, placebo-controlled randomized clinical trial aims to compare the effects of SNM to a placebo (sham) group. The study focuses on key bladder diary variables and overall changes in pelvic organ function while assessing safety and device characteristics. The trial begins with a SNM procedure followed by a 3-4 week test period. Patients showing more than 50% improvement in bladder diary variables will have an implantable pulse generator (IPG) implanted. After a month of optimization, participants are randomized into two groups: one with the IPG turned ON (active treatment) and the other with the IPG turned OFF (placebo). The randomized phase lasts four months, and participants are followed for six months with additional long-term follow-up every six months for a total of five years. Participants will undergo evaluations at baseline, after the test period, at randomization, and at the end of the study. Data collected include bladder, bowel, and sexual function assessments using patient-reported outcome measures, quality of life questionnaires, urodynamic testing, and monitoring of implantation and reprogramming needs. The main outcome is the success of SNM measured by improvements in bladder function at six months, along with safety assessments and long-term follow-up over five years.
CONDITIONS
Brief Title
Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 80 years
- Refractory neurogenic lower urinary tract dysfunction defined by a treatment satisfaction score less than 50
- No effect of medical treatments like antimuscarinics, beta3-agonists, and alpha-blockers
- Expanded Disability Status Scale (EDSS) less than 5 with no progression of neurological disease within 6 months
- Written informed consent and ability to understand study information
You will not qualify if you...
- EDSS greater than 5 or severe neurological progression within last 6 months
- Age under 18 years
- Any urological pathology other than neurogenic lower urinary tract dysfunction
- Bladder Pain Syndrome or Interstitial cystitis
- Other intestinal or gynecological pathologies not related to neurological symptoms
- Current pelvic cancer or significant pelvic mass
- Previous pelvic radiotherapy
- Bladder injections with botulinum neurotoxin type A within 6 months before enrollment
- Inability to manage electronic devices
- Inability to give informed consent
AI-Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 6 months
Participants receive sacral neuromodulation with the neuromodulator device turned ON or OFF to assess its effect on neurogenic lower urinary tract, bowel, and sexual dysfunction.
Baseline visit followed by visits at 3 weeks, randomization, and end of study
Follow-up
Duration - Up to 5 years
Participants are followed up every 6 months for up to 5 years to monitor long-term outcomes and safety.
Visits every 6 months
Trial Site Locations
Total: 1 location
1
Odense University Hospital
Odense, Fyn, Denmark, 5000
Actively Recruiting
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Research Team
H
Hanne Kobberø
M
Mads H Poulsen
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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