PMID- 36125509
OWN - NLM
STAT- MEDLINE
DCOM- 20230605
LR  - 20230713
IS  - 1433-3023 (Electronic)
IS  - 0937-3462 (Linking)
VI  - 34
IP  - 6
DP  - 2023 Jun
TI  - Peroneal electrical transcutaneous neuromodulation in the home treatment of the 
      refractory overactive bladder.
PG  - 1253-1260
LID - 10.1007/s00192-022-05359-3 [doi]
AB  - INTRODUCTION AND HYPOTHESIS: The aim of this prospective, open-label, 
      multicenter, noncomparative study was to evaluate the efficacy and safety of 
      peroneal electrical transcutaneous neuromodulation (peroneal eTNM((R))) using the 
      URIS((R)) neuromodulation system as a home treatment for refractory overactive 
      bladder (OAB). METHODS: The patients were treated with daily peroneal eTNM((R)) for 
      30 min over a 6-week period. The primary endpoint was defined as the proportion 
      of responders, i.e., participants with >/= 50% reduction in the average daily sum 
      of severe urgency episodes (defined as "I could not postpone voiding but had to 
      rush to the toilet in order not to wet myself") and urgency incontinence 
      episodes. In addition, bladder diary variables, symptom severity (OAB V8 
      questionnaire), treatment satisfaction (visual analog scale), and pain perception 
      (visual analog scale) were evaluated at baseline (BL), at week 4 (W4), and at the 
      end of treatment (EoT). Safety evaluations included monitoring of the incidence 
      and severity of adverse events (AEs). Changes in time were analyzed using the 
      nonparametric one-way ANOVA Friedman test for categorical variables and the 
      Wilcoxon rank-sum test for the noncategorical variables. RESULTS: In total, 40 
      subjects were screened and 29 were included in the full analysis set. The 
      proportion of responders was 86% at W4 and 79% at EoT. There was a significant 
      reduction in frequency (p<0.001), number of severe urgency episodes (p< 0.001), 
      number of urgency incontinence episodes (p=0.001), and number of nocturia 
      episodes (p=0.002). There was a significant improvement in the OAB V8 score and 
      treatment satisfaction (both p<0.001). Two mild treatment-related AEs were 
      recorded. Both patients recovered without sequelae and completed the study. 
      CONCLUSIONS: Peroneal eTNM((R)) proved to be a highly effective and safe method for 
      the home treatment of OAB, providing a therapeutic response in approximately 80% 
      of patients.
CI  - (c) 2022. The International Urogynecological Association.
FAU - Krhut, Jan
AU  - Krhut J
AUID- ORCID: 0000-0003-4205-5926
AD  - Department of Urology, University Hospital, Tr. 17. Listopadu 1790, 708 52, 
      Ostrava, Czech Republic. jan.krhut@fno.cz.
AD  - Department of Surgical Studies, Medical Faculty, Ostrava University, Ostrava, 
      Czech Republic. jan.krhut@fno.cz.
FAU - Rejchrt, Michal
AU  - Rejchrt M
AD  - Department of Urology, 2nd Faculty of Medicine of Charles University and Motol 
      University Hospital, Prague, Czech Republic.
FAU - Slovak, Martin
AU  - Slovak M
AD  - STIMVIA(R), Ostrava, Czech Republic.
FAU - Dvorak, Roman V
AU  - Dvorak RV
AD  - STIMVIA(R), Ostrava, Czech Republic.
FAU - Grepl, Michal
AU  - Grepl M
AD  - Department of Urology, University Hospital, Tr. 17. Listopadu 1790, 708 52, 
      Ostrava, Czech Republic.
AD  - Department of Surgical Studies, Medical Faculty, Ostrava University, Ostrava, 
      Czech Republic.
FAU - Zvara, Peter
AU  - Zvara P
AD  - Biomedical Laboratory and Research Unit of Urology, Department of Clinical 
      Research, University of Southern Denmark, Odense, Denmark.
AD  - Department of Urology, Odense University Hospital, Odense, Denmark.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
DEP - 20220920
PL  - England
TA  - Int Urogynecol J
JT  - International urogynecology journal
JID - 101567041
SB  - IM
MH  - Humans
MH  - *Urinary Bladder, Overactive/drug therapy
MH  - Prospective Studies
MH  - Treatment Outcome
MH  - *Urinary Incontinence
MH  - Urination/physiology
OTO - NOTNLM
OT  - Home-based therapy
OT  - Overactive bladder
OT  - Peroneal electrical transcutaneous neuromodulation
OT  - Peroneal nerve
OT  - Urgency
EDAT- 2022/09/21 06:00
MHDA- 2023/06/05 06:42
CRDT- 2022/09/20 11:12
PHST- 2022/06/16 00:00 [received]
PHST- 2022/08/25 00:00 [accepted]
PHST- 2023/06/05 06:42 [medline]
PHST- 2022/09/21 06:00 [pubmed]
PHST- 2022/09/20 11:12 [entrez]
AID - 10.1007/s00192-022-05359-3 [pii]
AID - 10.1007/s00192-022-05359-3 [doi]
PST - ppublish
SO  - Int Urogynecol J. 2023 Jun;34(6):1253-1260. doi: 10.1007/s00192-022-05359-3. Epub 
      2022 Sep 20.