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Clinical Trial Summary

Prevalence of lower urinary tract symptoms (LUTS) in patients with 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. To investigate the performance and safety of the medical device eCoin™ for the treatment of refractory LUTS in patients with MS over a period of 6 months.


Clinical Trial Description

This is a prospective, interventional, single arm, self-controlled pilot study in patients with multiple sclerosis and OAB symptoms with a 6-month treatment period of posterior tibial nerve stimulation with the medical device eCoin. It is a pilot study to explore the effectiveness and safety of using this device to treat MS patients with OAB in daily clinical practice in. Based on feasibility considerations, we plan to include approximately 20 patients. It consists of: 1. wash-out period from PTNS treatment of at least 2 months; 2. baseline assessments; 3. implantation of eCoin; 4. system activation; and 5. treatment and follow-up visits for a 6-month period post implant activation. Seven Visits are foreseen during the trial. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03753698
Study type Interventional
Source Ente Ospedaliero Cantonale, Bellinzona
Contact
Status Withdrawn
Phase N/A
Start date July 1, 2020
Completion date December 31, 2022

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