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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital Ostrava

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 volunteers

Qualifiers

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

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Peroneal eTNM

    Procedure/Surgery

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

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: Peroneal eTNM1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: