Efficacy and Safety of Peroneal Electric Transcutaneous Neuromodulation in the Real-world Clinical Practice
27. august 2026 opdateret af: University Hospital Ostrava
Efficacy and Safety of Peroneal Electric Transcutaneous Neuromodulation (Peroneal eTNM) in the Real-world Clinical Practice
The aim of the project is to study neuromodulation treatment in patients with idiopathic overactive bladder syndrome (OAB) in real clinical practice.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
A relatively new method of neuromodulation treatment of idiopathic OAB will be studied in the form of peroneal electrical transcutaneous neuromodulation (peroneal eTNM). Its principle is completely non-invasive, but highly selective stimulation of the peroneal nerve. Neuromodulation is performed using a surface electrode attached to the laterocaudal region of the popliteal fossa, where this nerve can be very well influenced due to its relatively superficial course. Nerve stimulation is performed intermittently in a doctor's office, the duration of application is 30 min., it is usually repeated once a week for at least 12 weeks.
The study is designed as a prospective, multicentre, non-interventional, observational study. Only data that is part of the standard examination and treatment process based on an extract from the standard medical documentation prepared by the attending physician will be collected and subsequently evaluated.
Undersøgelsestype
Observationel
Tilmelding (Anslået)
300
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Jiří Hynčica
- Telefonnummer: 2587 +42059737
- E-mail: jiri.hyncica@fno.cz
Undersøgelse Kontakt Backup
- Navn: Jan Krhut, prof.,MD,Ph.D.
- Telefonnummer: 2731 +42059737
- E-mail: jan.krhut@fno.cz
Studiesteder
-
-
Moravian-Silesian Region
-
Ostrava, Moravian-Silesian Region, Tjekkiet, 70852
- University Hospital Ostrava
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Patients with OAB.
Beskrivelse
Inclusion Criteria:
- Subjects (male and female) aged 18 years and over
- Subjects diagnosed with OAB or mixed urinary incontinence with a predominant urge component who were indicated for treatment with peroneal eTNM
- Subjects who consent to the processing of anonymized demographic data and anonymized treatment data with peroneal eTNM
Exclusion Criteria:
- Subjects with contraindications to treatment with peroneal eTNM
- Subjects who express their disagreement with the processing of anonymised demographic data and anonymised treatment data with peroneal eTNM
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Peroneal eTNM
Patients with OAB who will undergo treatment with peroneal electrical transcutaneous neuromodulation (peroneal eTNM).
|
Peroneal electrical transcutaneous neuromodulation (peroneal eTNM) is used to stimulate the peroneal nerve to positively influence the symptoms of OAB.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Patient improvement measured using PGI-I tool
Tidsramme: 12 weeks
|
Patient improvement will be measured using validated PGI-I tool.
PGI-I is a psychometric rating tool used to measure patient treatment satisfaction on a ranked scale.
|
12 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall treatment effect (OAB-V8)
Tidsramme: 12 weeks
|
The overall treatment effect will be measured using the OAB-V8 tool.
It is an 8-question medical screening tool used to identify symptoms severity of an overactive bladder (OAB) and measure how much those symptoms bother a patient.
|
12 weeks
|
|
Overall treatment safety
Tidsramme: 12 weeks
|
Overall treatment safety will be measured by the number and severity of adverse events.
|
12 weeks
|
|
Predictive factors for clinical treatment success (PGI-I)
Tidsramme: 12 weeks
|
Multivariate analysis of predictive factors for clinical treatment success (sex, age, comorbidities, concomitant medication, stimulation parameters).
|
12 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Jan Krhut, prof.,MD,Ph.D., University Hospital Ostrava
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-committee of the International Continence Society. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21(2):167-78. doi: 10.1002/nau.10052. No abstract available.
- Irwin DE, Milsom I, Hunskaar S, Reilly K, Kopp Z, Herschorn S, Coyne K, Kelleher C, Hampel C, Artibani W, Abrams P. Population-based survey of urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five countries: results of the EPIC study. Eur Urol. 2006 Dec;50(6):1306-14; discussion 1314-5. doi: 10.1016/j.eururo.2006.09.019. Epub 2006 Oct 2.
- Nambiar AK, Arlandis S, Bo K, Cobussen-Boekhorst H, Costantini E, de Heide M, Farag F, Groen J, Karavitakis M, Lapitan MC, Manso M, Arteaga SM, Riogh ANA, O'Connor E, Omar MI, Peyronnet B, Phe V, Sakalis VI, Sihra N, Tzelves L, van Poelgeest-Pomfret ML, van den Bos TWL, van der Vaart H, Harding CK. European Association of Urology Guidelines on the Diagnosis and Management of Female Non-neurogenic Lower Urinary Tract Symptoms. Part 1: Diagnostics, Overactive Bladder, Stress Urinary Incontinence, and Mixed Urinary Incontinence. Eur Urol. 2022 Jul;82(1):49-59. doi: 10.1016/j.eururo.2022.01.045. Epub 2022 Feb 23.
- Milsom I, Abrams P, Cardozo L, Roberts RG, Thuroff J, Wein AJ. How widespread are the symptoms of an overactive bladder and how are they managed? A population-based prevalence study. BJU Int. 2001 Jun;87(9):760-6. doi: 10.1046/j.1464-410x.2001.02228.x.
- Krhut J, Rejchrt M, Slovak M, Dvorak RV, Peter L, Blok BFM, Zvara P. Prospective, Randomized, Multicenter Trial of Peroneal Electrical Transcutaneous Neuromodulation vs Solifenacin in Treatment-naive Patients With Overactive Bladder. J Urol. 2023 Apr;209(4):734-741. doi: 10.1097/JU.0000000000003141. Epub 2022 Dec 29.
- Rejchrt M, Krhut J, Gartner M, Blok BFM, Zvara P. Effect duration of the initial course of peroneal electrical Transcutaneous NeuroModulation in patients with overactive bladder. World J Urol. 2023 Jun;41(6):1629-1634. doi: 10.1007/s00345-023-04394-z. Epub 2023 Apr 7.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. september 2026
Primær færdiggørelse (Anslået)
1. september 2028
Studieafslutning (Anslået)
1. december 2028
Datoer for studieregistrering
Først indsendt
27. august 2026
Først indsendt, der opfyldte QC-kriterier
27. august 2026
Først opslået (Faktiske)
1. september 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
1. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
27. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- FNO Peroneal eTNM
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
There is no plan to make individual participant data available to other researchers.
The data may be provided upon reasonable request.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .