Evidence map›Paper›PMID 37975785›Full record

Trial reportEuropean journal of neurology2024

Efficacy and safety of the implantable, magnetic resonance imaging-compatible StimRouter neuromodulation system in the treatment of refractory lower urinary tract symptoms in multiple sclerosis patients.

Rosaria Sacco, Paolo Maino, Eva Koetsier, Giulio Disanto, Julien Renard, Alex Digesu, Claudio Gobbi, Chiara Zecca

Open access · hybridAbstract readClinical Trial
In one paragraph

Trial report in European journal of neurology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
2.4field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 8 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
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  5. Article
  6. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 4 institutions in 2 countries.

Rosaria SaccoDepartment of Neurology, Multiple Sclerosis Center, Neurocenter of Southern Switzerland, Regional Hospital (EOC) of Lugano, Lugano, Switzerland.ORCID 0000-0002-6623-4649
Paolo MainoAnestesiologia, Neurocenter of Southern Switzerland, Regional Hospital (EOC) of Lugano, Lugano, Switzerland.
Eva KoetsierAnestesiologia, Neurocenter of Southern Switzerland, Regional Hospital (EOC) of Lugano, Lugano, Switzerland.
Giulio DisantoDepartment of Neurology, Multiple Sclerosis Center, Neurocenter of Southern Switzerland, Regional Hospital (EOC) of Lugano, Lugano, Switzerland.ORCID 0000-0002-8512-6096
Julien RenardUrology Service, Ospedale Regionale di Bellinzona e Valli (EOC), Bellinzona, Switzerland.
Alex DigesuDepartment of Urogynaecology, Imperial College Healthcare NHS Trust, London, UK.
Claudio GobbiDepartment of Neurology, Multiple Sclerosis Center, Neurocenter of Southern Switzerland, Regional Hospital (EOC) of Lugano, Lugano, Switzerland.ORCID 0000-0002-7554-0664
Chiara ZeccaDepartment of Neurology, Multiple Sclerosis Center, Neurocenter of Southern Switzerland, Regional Hospital (EOC) of Lugano, Lugano, Switzerland.ORCID 0000-0002-9990-3431
Ospedale regionale di Lugano · CHLaboratory for Biomedical Neurosciences · CHImperial College Healthcare NHS Trust · GBOspedale Regionale di Bellinzona e Valli · CH

Funding

Research Advisory Board of Ente Ospedaliero Cantonale (EOC)the Swiss Multiple Sclerosis Society
6 · The paper itself

Abstract

background and purposeLower urinary tract symptoms (LUTS) significantly affect quality of life (QoL) of multiple sclerosis (MS) patients, and pharmacotherapy has limited efficacy. We investigated efficacy and safety of the implantable StimRouter neuromodulation system for treating refractory LUTS in MS.

methodsThis prospective, single-center, clinical trial was conducted at the Multiple Sclerosis Center of Lugano, Switzerland, involving MS patients treated with self-administered percutaneous tibial nerve stimulation delivered by StimRouter over 24 weeks. Changes in video-urodynamic parameters as well as LUTS severity were measured by Overactive Bladder Questionnaire (OAB-q), QoL using the Multiple Sclerosis Quality of Life (MSQoL-54), and treatment satisfaction using a 1-10 visual analogue scale. Adverse events were also recorded.

resultsOf 23 MS patients recruited, six had neurogenic detrusor overactivity (NDO), five had detrusor sphincter dyssynergia (DSD), and 12 had both NDO and DSD. Of patients with NDO, median bladder volume at first uninhibited contraction significantly increased from baseline to week 24 (median = 136 mL, interquartile range [IQR] = 101-244 mL vs. 343 mL, IQR = 237-391 mL; β = 138.2, p = 0.001). No significant changes of urodynamic parameters were found in patients with DSD. OAB-q symptom scores progressively decreased, and OAB-q quality of life scores increased (β = -0.50, p < 0.001 and β = 0.47, p < 0.001, respectively), whereas MSQoL-54 scores did not significantly change (β = 0.24, p = 0.084) in the overall population. Treatment satisfaction was overall high (median = 8, IQR = 6-9). No serious adverse events were recorded.

conclusionsStimRouter represents a minimally invasive, magnetic resonance imaging-compatible, self-administered neuromodulation device leading to objective and subjective improvements of OAB symptoms and related QoL in MS patients with refractory LUTS.

Indexed as

Lower Urinary Tract SymptomsMultiple SclerosisUrinary Bladder, NeurogenicUrinary Bladder, OveractiveHumansProspective StudiesQuality of LifeTreatment OutcomeUrodynamicsdetrusor sphincter dyssynergialower urinary tract symptomsmultiple sclerosisneurogenic detrusor overactivityStimRouter neuromodulation

Identifiers

PMID37975785
PMCPMC11235585
OpenAlexW4388783399

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.