Clinical trial of percutaneous tibial nerve stimulation with the implantable StimRouter neuromodulation system was started

Photo by John Jackson

Deputy Head of Multiple Sclerosis Center Chiara Zecca from Ente Ospedaliero Cantonale, Bellinzona is commencing recruitment for the clinical trial of the Wireless, Implantable Tibial Nerve Stimulator System for the Treatment of Refractory Lower Urinary Tract Symptoms in Patients With Multiple Sclerosis.

The condition is Multiple Sclerosis, Relapsing-Remitting.

A new clinical trial is recruiting patients in the following locations: Switzerland.

The trial officially began on the August 26, 2020 and is planned to complete on December 31, 2021.

Prevalence of lower urinary tract symptoms (LUTS) in patients with multiple sclerosis (MS) increases with disease duration. Current management of urinary clinical symptoms in MS is mainly conservative. Its long-term outcome is often poor because of the progressive disease course and the treatment related side effects. Alternative therapeutic options are botulinum toxin injections, electrical stimulation of dorsal penile/clitoral nerve, and sacral nerve modulation. Posterior tibial nerve stimulation (PTNS) is a second minimally invasive method of electrical stimulation. Multiple benefits may derive from the development and validation of a dedicated protocol of a new self-activated neuromodulation therapy, which may improve therapy compliance/effectiveness, quality of life and social life in MS patients with refractory LUTS. Furthermore, it may contribute to reduce outpatient visits, health costs and work absenteeism.

Change in bladder volume is primary outcome measure.

ABREOC is the collaborator in this clinical trial.

The link to the complete study profile: https://ichgcp.net/clinical-trials-registry/NCT04567264.