Condition: Neurogenic Dysfunction of the Urinary Bladder · Multiple Sclerosis · Sacral Neuromodulation · Sponsor: Odense University Hospital
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
This description comes directly from the study's public registry record.
Hanne Kobberø · 004565414400 · hanne.kobberoe2@rsyd.dk
Mads H Poulsen · 004565414400 · mads.poulsen@rsyd.dk
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| Odense University Hospital | Odense, Fyn, Denmark | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05380856