About this trial
The aim of the project is to study neuromodulation treatment in patients with idiopathic overactive bladder syndrome (OAB) in real clinical practice.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 population
Patients with OAB.
Trial design
Case-only
Prospective
Treatments tested in this trial
Peroneal eTNM
Procedure/SurgeryPeroneal electrical transcutaneous neuromodulation (peroneal eTNM) is used to stimulate the peroneal nerve to positively influence the symptoms of OAB.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
Overall treatment safety
Overall treatment safety will be measured by the number and severity of adverse events.
Predictive factors for clinical treatment success (PGI-I)
Multivariate analysis of predictive factors for clinical treatment success (sex, age, comorbidities, concomitant medication, stimulation parameters).
Sponsors and contacts
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