Peroneal Neuromodulation vs Pelvic Floor Exercises in OAB

Comparison of the Efficacy of Transcutaneous Peroneal Electrical Neuromodulation and Pelvic Floor Exercises in the Treatment of Idiopathic Overactive Bladder

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.

Inclusion Criteria:

• 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.
• Ability to complete bladder diaries and symptom questionnaires.
• Willingness to participate in the study and provide written informed consent.
• Ability to comply with the assigned treatment protocol and scheduled follow-up visits.

Exclusion Criteria:

• 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.
• Clinically significant bladder outlet obstruction or urinary retention.
• History of major pelvic surgery or pelvic radiotherapy that may affect lower urinary tract function.
• Previous treatment with botulinum toxin injection or neuromodulation within the predefined washout period.
• Current use of OAB medications that cannot be discontinued or appropriately washed out before enrollment.
• Pregnancy.
• Presence of a cardiac pacemaker, implanted defibrillator, or another implanted electrical device incompatible with electrical stimulation.
• Any condition that, in the investigator's judgment, would prevent safe participation or adherence to the study protocol.