PMID- 37975785
OWN - NLM
STAT- MEDLINE
DCOM- 20240113
LR  - 20240113
IS  - 1468-1331 (Electronic)
IS  - 1351-5101 (Linking)
VI  - 31
IP  - 2
DP  - 2024 Feb
TI  - 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.
PG  - e16146
LID - 10.1111/ene.16146 [doi]
AB  - BACKGROUND AND PURPOSE: Lower 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. METHODS: 
      This 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. RESULTS: Of 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; beta = 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 
      (beta = -0.50, p < 0.001 and beta = 0.47, p < 0.001, respectively), whereas MSQoL-54 
      scores did not significantly change (beta = 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. CONCLUSIONS: StimRouter 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.
CI  - (c) 2023 The Authors. European Journal of Neurology published by John Wiley & Sons 
      Ltd on behalf of European Academy of Neurology.
FAU - Sacco, Rosaria
AU  - Sacco R
AUID- ORCID: 0000-0002-6623-4649
AD  - Department of Neurology, Multiple Sclerosis Center, Neurocenter of Southern 
      Switzerland, Regional Hospital (EOC) of Lugano, Lugano, Switzerland.
FAU - Maino, Paolo
AU  - Maino P
AD  - Anestesiologia, Neurocenter of Southern Switzerland, Regional Hospital (EOC) of 
      Lugano, Lugano, Switzerland.
AD  - Faculty of Biomedical Sciences, Universita della Svizzera Italiana (USI), Lugano, 
      Switzerland.
FAU - Koetsier, Eva
AU  - Koetsier E
AD  - Anestesiologia, Neurocenter of Southern Switzerland, Regional Hospital (EOC) of 
      Lugano, Lugano, Switzerland.
FAU - Disanto, Giulio
AU  - Disanto G
AUID- ORCID: 0000-0002-8512-6096
AD  - Department of Neurology, Multiple Sclerosis Center, Neurocenter of Southern 
      Switzerland, Regional Hospital (EOC) of Lugano, Lugano, Switzerland.
FAU - Renard, Julien
AU  - Renard J
AD  - Urology Service, Ospedale Regionale di Bellinzona e Valli (EOC), Bellinzona, 
      Switzerland.
FAU - Digesu, Alex
AU  - Digesu A
AD  - Department of Urogynaecology, Imperial College Healthcare NHS Trust, London, UK.
FAU - Gobbi, Claudio
AU  - Gobbi C
AUID- ORCID: 0000-0002-7554-0664
AD  - Department of Neurology, Multiple Sclerosis Center, Neurocenter of Southern 
      Switzerland, Regional Hospital (EOC) of Lugano, Lugano, Switzerland.
AD  - Faculty of Biomedical Sciences, Universita della Svizzera Italiana (USI), Lugano, 
      Switzerland.
FAU - Zecca, Chiara
AU  - Zecca C
AUID- ORCID: 0000-0002-9990-3431
AD  - Department of Neurology, Multiple Sclerosis Center, Neurocenter of Southern 
      Switzerland, Regional Hospital (EOC) of Lugano, Lugano, Switzerland.
AD  - Faculty of Biomedical Sciences, Universita della Svizzera Italiana (USI), Lugano, 
      Switzerland.
LA  - eng
GR  - Research Advisory Board of Ente Ospedaliero Cantonale (EOC)/
GR  - the Swiss Multiple Sclerosis Society/
PT  - Clinical Trial
PT  - Journal Article
DEP - 20231117
PL  - England
TA  - Eur J Neurol
JT  - European journal of neurology
JID - 9506311
SB  - IM
MH  - Humans
MH  - *Lower Urinary Tract Symptoms/etiology/therapy
MH  - *Multiple Sclerosis/complications/therapy
MH  - Prospective Studies
MH  - Quality of Life
MH  - Treatment Outcome
MH  - *Urinary Bladder, Neurogenic/drug therapy
MH  - *Urinary Bladder, Overactive/drug therapy
MH  - Urodynamics/physiology
OTO - NOTNLM
OT  - StimRouter neuromodulation
OT  - detrusor sphincter dyssynergia
OT  - lower urinary tract symptoms
OT  - multiple sclerosis
OT  - neurogenic detrusor overactivity
EDAT- 2023/11/17 15:31
MHDA- 2024/01/10 06:42
CRDT- 2023/11/17 09:53
PHST- 2023/09/29 00:00 [revised]
PHST- 2023/06/15 00:00 [received]
PHST- 2023/10/26 00:00 [accepted]
PHST- 2024/01/10 06:42 [medline]
PHST- 2023/11/17 15:31 [pubmed]
PHST- 2023/11/17 09:53 [entrez]
AID - 10.1111/ene.16146 [doi]
PST - ppublish
SO  - Eur J Neurol. 2024 Feb;31(2):e16146. doi: 10.1111/ene.16146. Epub 2023 Nov 17.