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
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
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
Odense University Hospital
Lead sponsor
University of Copenhagen
Collaborator
Université de Nantes
Collaborator
University of Ostrava
Collaborator