Trials / Completed
CompletedNCT04567264
Wireless, Implantable Tibial Nerve Stimulator System for the Treatment of Refractory Lower Urinary Tract Symptoms in Patients With Multiple Sclerosis
Prospective Single Centre Trial of Percutaneous Tibial Nerve Stimulation With the Implantable StimRouter Neuromodulation System for the Treatment of Refractory Lower Urinary Tract Symptoms in Patients With Multiple Sclerosis
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 23 (actual)
- Sponsor
- Chiara Zecca · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | StimRouter®, Self-activated and self-controlled neuromodulation device (Bioness Inc, CE0086). | Regimen 1 (weeks 0-12): one stimulation every 2 days, for a duration of 30 minutes each. Regimen 2 (weeks 12-24): Three stimulation treatments per week, for a duration of 30 minutes each. |
Timeline
- Start date
- 2020-08-26
- Primary completion
- 2022-06-30
- Completion
- 2022-06-30
- First posted
- 2020-09-28
- Last updated
- 2023-09-07
Locations
1 site across 1 country: Switzerland
Source: ClinicalTrials.gov record NCT04567264. Inclusion in this directory is not an endorsement.