Prospective, Randomized, Multicenter Trial of Peroneal Electrical Transcutaneous NeuroModulation versus Solifenacin in Treatment of Naïve Patients with Overactive Bladder
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064203%3A_____%2F23%3A10452826" target="_blank" >RIV/00064203:_____/23:10452826 - isvavai.cz</a>
Alternative codes found
RIV/00216208:11130/23:10452826
Result on the web
<a href="https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=Rvnw1K0pQ" target="_blank" >https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=Rvnw1K0pQ</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1097/JU.0000000000003141" target="_blank" >10.1097/JU.0000000000003141</a>
Alternative languages
Result language
angličtina
Original language name
Prospective, Randomized, Multicenter Trial of Peroneal Electrical Transcutaneous NeuroModulation versus Solifenacin in Treatment of Naïve Patients with Overactive Bladder
Original language description
PURPOSE: To investigate the safety and efficacy of peroneal electrical Transcutaneous NeuroModulation (peroneal eTNM) using the URISneuromodulation system in a home-based setting in comparison with standard treatment using solifenacin, in treatment-naïve female patients with overactive bladder. MATERIALS AND METHODS: A total of 120 patients were screened, of whom 77 were randomized in a 2:1 ratio to 12 weeks of treatment with daily peroneal eTNM or solifenacin 5 mg. The primary endpoint was safety, efficacy assessments included proportion of responders, defined as subjects with>=50% reduction in bladder diary-derived variables; OAB V8 questionnaire, and EQ-5D-5L questionnaire; and treatment satisfaction after 12 weeks of therapy. RESULTS: Seventy one out of 77 randomized patients completed the study. In the peroneal eTNM group 6/51 (12%), in the solifenacin group 12/25 (48%) patients reported a treatment-related adverse event, respectively (P<.001). No clinically significant changes were observed in any other safety endpoint. The proportions of responders in the peroneal eTNM group vs the solifenacin group were, respectively, 87% vs 74% with respect to Patient Perception of Intensity of Urgency Scale (PPIUS) Grade 3 urgency episodes, 87% vs 75% with respect to PPIUS Grade 3+4 urgency episodes, and 90% vs 94% with respect to urgency incontinence episodes. In post-hoc analyses we observed significant improvement over time in multiple efficacy variables in both treatment arms. CONCLUSIONS: Peroneal eTNM is a safe and effective method for OAB treatment associated with significantly lower incidence of treatment-related adverse events compared to solifenacin and considerably better benefit-risk profile.
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
30217 - Urology and nephrology
Result continuities
Project
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Continuities
I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace
Others
Publication year
2023
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
Journal of Urology
ISSN
0022-5347
e-ISSN
1527-3792
Volume of the periodical
209
Issue of the periodical within the volume
4
Country of publishing house
US - UNITED STATES
Number of pages
8
Pages from-to
734-741
UT code for WoS article
000970541400026
EID of the result in the Scopus database
2-s2.0-85149978980