ClinicalTrials.gg
Not yet recruitingNCT07796958Updated Sep 1, 2026

Efficacy and Safety of Peroneal Electric Transcutaneous Neuromodulation in the Real-world Clinical Practice

An observational study in Overactive Bladder Syndrome, sponsored by University Hospital Ostrava. Not yet recruiting at 1 site in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-01.

Sponsored by University Hospital Ostrava · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
300
Ages
18 Years and older
Sex
All
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Study summary

The aim of the project is to study neuromodulation treatment in patients with idiopathic overactive bladder syndrome (OAB) in real clinical practice.

Read the detailed description

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.

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Conditions studied

  • Overactive Bladder Syndrome

Keywords

  • Overactive Bladder Syndrome
  • Peripheral Neuromodulation Treatment
  • Peroneal Electrical Transcutaneous Neuromodulation (peroneal eTNM)
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In context

Urinary Bladder, Overactive

858 studies on the registry are indexed under Urinary Bladder, Overactive; 127 are open to participants now.

This study's planned enrollment of 300 is above the median of 120 across 169 observational studies indexed under Urinary Bladder, Overactive.

Browse Urinary Bladder, Overactive studies →

Lead sponsor

University Hospital Ostrava is the lead sponsor of 148 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with OAB.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Subjects with to treatment with peroneal eTNM
  • Subjects who express their disagreement with the processing of anonymised demographic data and anonymised treatment data with peroneal eTNM
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • Peroneal eTNM

    Patients with OAB who will undergo treatment with peroneal electrical transcutaneous neuromodulation (peroneal eTNM).

    Procedure: Peroneal eTNM

Interventions

  • ProcedurePeroneal eTNM

    Peroneal electrical transcutaneous neuromodulation (peroneal eTNM) is used to stimulate the peroneal nerve to positively influence the symptoms of OAB.

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What researchers measure

Primary outcomes

  1. Patient improvement measured using PGI-I tool

    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.

    Time frame: 12 weeks

Secondary outcomes

  1. Overall treatment effect (OAB-V8)

    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.

    Time frame: 12 weeks

  2. Overall treatment safety

    Overall treatment safety will be measured by the number and severity of adverse events.

    Time frame: 12 weeks

  3. Predictive factors for clinical treatment success (PGI-I)

    Multivariate analysis of predictive factors for clinical treatment success (sex, age, comorbidities, concomitant medication, stimulation parameters).

    Time frame: 12 weeks

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Study locations

1 site
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References and documents

Publications

  • 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. PubMed 11857671 ↗
  • 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. PubMed 17049716 ↗
  • 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. PubMed 11412210 ↗
  • 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. PubMed 35216856 ↗
  • 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. PubMed 36579932 ↗
  • 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. PubMed 37027023 ↗

Individual participant data

Plan to share: No — There is no plan to make individual participant data available to other researchers. The data may be provided upon reasonable request.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07796958
Responsible party
Sponsor
First posted
Sep 1, 2026
Start date
Sep 2026 (estimated)
Primary completion
Sep 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Sep 1, 2026

Study contacts

Jan Krhut, prof.,MD,Ph.D.
Contact
jan.krhut@fno.cz
+42059737 ext. 2731
Jiří Hynčica
Contact
jiri.hyncica@fno.cz
+42059737 ext. 2587
Jan Krhut, prof.,MD,Ph.D.
principal investigator · University Hospital Ostrava

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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