Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction
Recruiting · NCT05380856 · Interventional (participants receive a specific treatment) · Lead sponsor: Odense University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
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
Who can take part
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
Where it is running
1 location listed.
- Odense University Hospital - Odense, Fyn, Denmark