Prospective, Randomized, Multicenter Trial of Peroneal Electrical Transcutaneous NeuroModulation versus Solifenacin in Treatment of Naïve Patients with Overactive Bladder

Kód výsledku v 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>

Nalezeny alternativní kódy

RIV/00216208:11130/23:10452826

Výsledek na webu

<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>

Jazyk výsledku

angličtina

Název v původním jazyce

Prospective, Randomized, Multicenter Trial of Peroneal Electrical Transcutaneous NeuroModulation versus Solifenacin in Treatment of Naïve Patients with Overactive Bladder

Popis výsledku v původním jazyce

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&gt;=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&lt;.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.

Název v anglickém jazyce

Prospective, Randomized, Multicenter Trial of Peroneal Electrical Transcutaneous NeuroModulation versus Solifenacin in Treatment of Naïve Patients with Overactive Bladder

Popis výsledku anglicky

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&gt;=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&lt;.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.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30217 - Urology and nephrology

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2023

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Journal of Urology

ISSN

0022-5347

e-ISSN

1527-3792

Svazek periodika

209

Číslo periodika v rámci svazku

4

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

8

Strana od-do

734-741

Kód UT WoS článku

000970541400026

EID výsledku v databázi Scopus

2-s2.0-85149978980