Peroneal Neuromodulation vs Pelvic Floor Exercises in OAB
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMarmara University
About this trial
Overactive bladder (OAB) is a common condition characterized by urinary urgency, usually accompanied by increased urinary frequency and nocturia, with or without urgency urinary incontinence. Several non-invasive treatment options are available, including pelvic floor exercises and neuromodulation.
This prospective, randomized study aims to compare the effectiveness and safety of transcutaneous peroneal electrical neuromodulation and pelvic floor exercises in adults with idiopathic OAB. Participants will be randomly assigned in a 1:1 ratio to receive either transcutaneous peroneal neuromodulation or pelvic floor exercise therapy for 3 months.
Treatment outcomes will be assessed using bladder diary parameters and OAB symptom scores at baseline and at 1 and 3 months after treatment initiation. Treatment adherence and treatment-related adverse events will also be evaluated. The study aims to determine whether transcutaneous peroneal neuromodulation provides comparable or improved clinical outcomes compared with pelvic floor exercises in patients with idiopathic OAB.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 years or older.
Diagnosis of idiopathic overactive bladder (OAB) based on clinical evaluation.
Presence of urinary urgency, with or without urgency urinary incontinence, usually accompanied by increased urinary frequency and/or nocturia.
OAB symptoms present for at least 3 months.
Disqualifiers
Neurogenic lower urinary tract dysfunction or a known neurological disease affecting bladder function.
Active urinary tract infection at the time of enrollment.
Significant pelvic organ prolapse.
Predominant stress urinary incontinence or mixed urinary incontinence with predominant stress symptoms.
Trial design
Design model
Parallel
Treatments tested in this trial
Transcutaneous Peroneal Electrical Neuromodulation
DeviceTranscutaneous peroneal electrical neuromodulation will be administered once weekly for 3 months. Each treatment session will last 30 minutes. Electrical stimulation will be delivered transcutaneously over the peroneal nerve using surface electrodes.
Pelvic Floor Exercise
BehavioralParticipants will undergo pelvic floor muscle training for 3 months according to a standardized exercise protocol. The exercises will be taught and supervised by the same trained physiotherapist to ensure standardized treatment across participants.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Transcutaneous peroneal electrical neuromodulationActive comparator 1 intervention
Group B: Pelvic Floor ExercisesActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Overactive Bladder Symptom Score from baseline to 3 months
The change in overactive bladder symptom severity will be assessed using the validated Overactive Bladder Questionnaire (OAB-V8). Scores will be recorded at baseline and at 3 months after initiation of treatment. A greater reduction in score indicates greater improvement in overactive bladder symptoms.
Time frame
Baseline to 3 monthsSponsors and contacts
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Source ClinicalTrials.gov
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