AIMS: We present results of a two-arm pilot study assessing the feasibility of conducting a double-blind randomized controlled trial (RCT) to evaluate the efficacy of sacral neuromodulation (SNM) in patients with multiple sclerosis (MS) suffering from neurogenic lower urinary tract dysfunction (NLUTD). METHODS: Eligible subjects with refractory NLUTD and EDSS < 5 underwent SNM test phase. Those showing more than a 50% improvement of bladder variables, received implantable pulse generators (IPG) and were randomized to either treatment group (IPG ON) or to sham group (IPG OFF) for 1 month. During second month, all patients had the IPG ON until the end of the trial. The primary endpoints were trial feasibility, recruitment potential, and response rate at the end of SNM test phase. Secondary endpoint was safety. Changes in key bladder diary-derived variables and patient reported outcomes were recorded as well. RESULTS: Thirty-two patients were screened, 17 were eligible and 13 were included in the SNM test phase. Eleven were considered responders and were implanted with IPG. Subsequently, six patients were randomized to the treatment group and five to the sham group. No serious adverse events were reported. In the intervention phase, both objective and subjective improvements were seen in the treatment group, while the symptoms in the sham group remained mostly unchanged. At study completion, six patients reported being completely satisfied, three were mostly satisfied, and two were indifferent to the treatment. CONCLUSIONS: This pilot trial demonstrated feasibility of double-blind RCT assessing safety and efficacy of SNM in MS patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT05380856.

BRIDGE Brain Research Inter Disciplinary Guided Excellence University of Southern Denmark Odense Denmark

Department of Clinical Medicine University of Copenhagen Copenhagen Denmark

Department of Clinical Research Research Unit of Urology University of Southern Denmark Odense Denmark

Department of Neurology Odense University Hospital Odense Denmark

Department of Regional Health Research University of Southern Denmark Odense Denmark

Department of Surgical Studies Ostrava University Ostrava Czech Republic

Department of Urology Copenhagen University Hospital Herlev and Gentofte Hospital Copenhagen Denmark

Department of Urology Esbjerg and Grindsted Hospital University Hospital of Southern Denmark Esbjerg Denmark

Department of Urology Odense University Hospital Odense Denmark

Department of Urology University Hospital Ostrava Ostrava Czech Republic

Institute of Molecular Medicine Neurobiology Research University of Southern Denmark Odense Denmark

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ClinicalTrials.gov
NCT05380856