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NCT04567264: Stimrouter
Wireless, Implantable Tibial Nerve Stimulator System for the Treatment of Refractory Lower Urinary Tract Symptoms in Patients With Multiple Sclerosis
NA trial testing StimRouter®, Self-activated and self-controlled neuromodulation device (Bioness Inc, CE0086). in Multiple Sclerosis, Relapsing-Remitting in 23 participants. Completed in 30 June 2022.
30 June 2022
Quick facts
| Lead sponsor | Chiara Zecca |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 23 |
| Start date | 26 August 2020 |
| Primary completion | 30 June 2022 |
| Estimated completion | 30 June 2022 |
| Sites | 1 location across Switzerland |
Drugs / interventions tested
- StimRouter®, Self-activated and self-controlled neuromodulation device (Bioness Inc, CE0086).
Conditions studied
- Multiple Sclerosis, Relapsing-Remitting — all drugs for Multiple Sclerosis, Relapsing-Remitting →
Sponsor
Chiara Zecca
Who can join
Adults 18 to 80, any sex, with Multiple Sclerosis, Relapsing-Remitting. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04567264
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Multiple Sclerosis, Relapsing-Remitting
Currently open trials in the same condition.
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- NCT06569550 — Fatigue Alleviation Through Neuromodulating Therapy in Multiple Sclerosis · NA · recruiting
- NCT06389968 — Light Stimulation to Improve Visual Function After Optic Neuritis in Persons with Multiple Sclerosis · NA · recruiting
- NCT06345157 — ITAKOS - Italian Observation, Multicenter, Prospective Study of Ofatumumab in RRMS Patients · active not recruiting
- NCT06715436 — Multiple Sclerosis and the Effects of Ketogenic Diet Therapy · NA · recruiting
Other Chiara Zecca trials
Trials by the same sponsor.
- NCT03753698 — Wireless, Implantable Tibial Nerve Stimulator System (eCoin™) for the Treatment of Refractory Lower Urinary Tract Sympto · NA · withdrawn
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04567264 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Chiara Zecca
- Last refreshed: 7 September 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04567264.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing