Overactive Bladder Syndrome
Conditions
Keywords
Overactive Bladder Syndrome, Peripheral Neuromodulation Treatment, Peroneal Electrical Transcutaneous Neuromodulation (peroneal eTNM)
Brief summary
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.
Interventions
PROCEDUREPeroneal eTNM
Peroneal electrical transcutaneous neuromodulation (peroneal eTNM) is used to stimulate the peroneal nerve to positively influence the symptoms of OAB.
Sponsors
University Hospital Ostrava
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient improvement measured using PGI-I tool | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall treatment effect (OAB-V8) | 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. |
| Overall treatment safety | 12 weeks | Overall treatment safety will be measured by the number and severity of adverse events. |
| Predictive factors for clinical treatment success (PGI-I) | 12 weeks | Multivariate analysis of predictive factors for clinical treatment success (sex, age, comorbidities, concomitant medication, stimulation parameters). |
Countries
Czechia
Contacts
CONTACTJan Krhut, prof.,MD,Ph.D.
CONTACTJiří Hynčica
PRINCIPAL_INVESTIGATORJan Krhut, prof.,MD,Ph.D.
University Hospital Ostrava
Outcome results
None listed