Overactive Bladder SyndromeNCT07796958
Efficacy and Safety of Peroneal Electric Transcutaneous Neuromodulation in the Real-world Clinical Practice
An observational study of Overactive Bladder Syndrome, run by University Hospital Ostrava at 1 site in Czechia.
Trial summary
The aim of the project is to study neuromodulation treatment in patients with idiopathic overactive bladder syndrome (OAB) in real clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overactive Bladder Syndrome
- What is being tested?
- Peroneal eTNM
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteCzechia
- Study dates
- Sep 2026to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with OAB.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 70852
About this study
Official title: 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.
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.
- Conditions
- Overactive Bladder Syndrome
- Being tested
- Peroneal eTNM
- Keywords
- Overactive Bladder Syndrome, Peripheral Neuromodulation Treatment, Peroneal Electrical Transcutaneous Neuromodulation (peroneal eTNM)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peroneal eTNMProcedure or surgery
Peroneal electrical transcutaneous neuromodulation (peroneal eTNM) is used to stimulate the peroneal nerve to positively influence the symptoms of OAB.
| Study group | Role | What they receive |
|---|---|---|
| Peroneal eTNM | Patients with OAB who will undergo treatment with peroneal electrical transcutaneous neuromodulation (peroneal eTNM). Receives: Procedure: Peroneal eTNM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (3)
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.
Measured: 12 weeks
Overall treatment safety
Overall treatment safety will be measured by the number and severity of adverse events.
Measured: 12 weeks
Predictive factors for clinical treatment success (PGI-I)
Multivariate analysis of predictive factors for clinical treatment success (sex, age, comorbidities, concomitant medication, stimulation parameters).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Overactive Bladder SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Krhut, prof.,MD,Ph.D., Principal investigator, University Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07796958
- Sponsor's protocol ID
- FNO Peroneal eTNM
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers. The data may be provided upon reasonable request.
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 11857671Irwin 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 17049716Milsom 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 11412210Nambiar 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 35216856Krhut 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 36579932Rejchrt 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
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Peroneal Electric Transcutaneous Neuromodulation (Peroneal eTNM) in the Real-world Clinical Practice
- ClinicalTrials.gov ID
- NCT07796958
- Acronym / sponsor ID
- FNO Peroneal eTNM
- Conditions
- Overactive Bladder Syndrome
- Keywords
- Overactive Bladder Syndrome, Peripheral Neuromodulation Treatment, Peroneal Electrical Transcutaneous Neuromodulation (peroneal eTNM)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 1 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the project is to study neuromodulation treatment in patients with idiopathic overactive bladder syndrome (OAB) in real clinical practice.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peroneal eTNM | – | Procedure: Peroneal eTNMPatients with OAB who will undergo treatment with peroneal electrical transcutaneous neuromodulation (peroneal eTNM). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with OAB.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peroneal eTNMPeroneal electrical transcutaneous neuromodulation (peroneal eTNM) is used to stimulate the peroneal nerve to positively influence the symptoms of OAB. | Procedure or surgery | Peroneal eTNM |
Primary outcome
Patient improvement measured using PGI-I tool
Time frame: 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.
3 secondary outcomes
Overall treatment effect (OAB-V8)
Time frame: 12 weeks
Overall treatment safety
Time frame: 12 weeks
Predictive factors for clinical treatment success (PGI-I)
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Background: PubMed 11857671Abrams 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.
- Background: PubMed 17049716Irwin 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.
- Background: PubMed 11412210Milsom 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.
- Background: PubMed 35216856Nambiar 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.
- Background: PubMed 36579932Krhut 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.
- Background: PubMed 37027023Rejchrt 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.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jan Krhut, prof.,MD,Ph.D. principal investigator
University Hospital Ostrava
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overactive Bladder Syndrome, run by University Hospital Ostrava at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jan Krhut, prof.,MD,Ph.D. (+42059737 ext. 2731, jan.krhut@fno.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient improvement measured using PGI-I tool (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07796958, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.