Status:
RECRUITING
Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction
Lead Sponsor:
Odense University Hospital
Collaborating Sponsors:
University of Copenhagen
Université de Nantes
Conditions:
Neurogenic Dysfunction of the Urinary Bladder
Multiple Sclerosis
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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 varia...
Detailed Description
Patients with MS often suffer from pelvic-organ dysfunctions, i.e. lower urinary tract (LUT), bowel and sexual dysfunction, aside their cerebral affection. Sacral neuromodulation (SNM) is a reversible...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 26 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05380856
Start Date
September 26 2023
End Date
March 1 2027
Last Update
March 20 2025
Active Locations (1)
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1
Odense University Hospital
Odense, Fyn, Denmark, 5000