Actively Recruiting
Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction
Led by Odense University Hospital · Updated on 2025-03-20
60
Participants Needed
1
Research Sites
178 weeks
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
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
CONDITIONS
Official Title
Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Refractory neurogenic lower urinary tract dysfunction with treatment satisfaction less than 50 on a visual analogue scale
- No effect of medical treatment including antimuscarinics, beta3-agonist, and alpha-blocker
- Intention to try sacral neuromodulation for symptom relief
- Expanded Disability Status Scale (EDSS) less than 5 with no neurological progression in the last 6 months
- Written informed consent
- Ability to understand study information
You will not qualify if you...
- EDSS greater than 5 or severe neurological progression within the last 6 months
- Inability to manage electronic devices
- Age under 18 years
- Any urological pathology other than neurogenic lower urinary tract dysfunction
- Bladder Pain Syndrome or Interstitial cystitis
- Any intestinal or gynecological pathology except neurological symptoms
- Current pelvic malignancy or significant pelvic mass
- Previous pelvic radiotherapy
- Bladder injections with botulinum neurotoxin type A within 6 months before inclusion
- Inability to give informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Odense University Hospital
Odense, Fyn, Denmark, 5000
Actively Recruiting
Research Team
H
Hanne Kobberø
CONTACT
M
Mads H Poulsen
CONTACT
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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