Treatment Efficacy for Overactive Bladder: Comparing Education, Biofeedback, and Nerve Stimulation

Overview

The purpose of this clinical trial is to evaluate the effectiveness of different behavioral therapies and neuromodulation for treating women with idiopathic Overactive Bladder (OAB). The study aims to compare three 8-week treatment plans: oral education on Pelvic Floor Muscle Training (PFMT), biofeedback-assisted PFMT, and biofeedback-assisted PFMT combined with tibial nerve electrical stimulation using the "Enraf-Nonius" EMG-Biofeedback Unit. The main question it aims to answer is whether adding biofeedback and peripheral nerve stimulation provides better relief for OAB symptoms (such as urinary urgency, frequency, and nocturia) compared to standard oral education on PFMT alone. Participants will be randomly assigned to one of the three treatment groups and will track their daily pelvic floor exercises at home using a smartphone timer application. The study will also analyze whether patients with different OAB phenotypes (OAB-wet versus OAB-dry) respond differently to these treatment interventions.

Overactive Bladder (OAB) is a syndrome characterized by urinary urgency, often accompanied by frequency and nocturia, with or without urgency urinary incontinence. Detrusor overactivity is considered the most common underlying cause. Pelvic Floor Muscle Training (PFMT) is a standard first-line behavioral therapy that helps inhibit detrusor contractions by strengthening the pelvic floor. This randomized controlled trial investigates the additive clinical value of biofeedback and neuromodulation on top of standard PFMT. Participants are stratified based on their clinical phenotype (OAB-wet or OAB-dry) and randomly assigned to one of three groups for an 8-week intervention period: Group 1 receives standard oral education on PFMT; Group 2 receives biofeedback-assisted PFMT to improve muscle contraction accuracy; and Group 3 receives biofeedback-assisted PFMT combined with percutaneous tibial nerve electrical stimulation. The neuromodulation intervention aims to inhibit involuntary detrusor contractions and regulate bladder nerve signals through peripheral nerve conduction. All clinical interventions and assessments are conducted in a dedicated, private biofeedback treatment room. Participants are scheduled for in-person clinic visits at weeks 0, 2, 4, and 8. During these visits, participants in Groups 1 and 2 will undergo routine assessment and muscle contraction quality checks lasting 30 to 40 minutes. Participants in Group 3 will additionally receive a 30 to 40-minute session of tibial nerve electrical stimulation (parameters: 20 Hz, 200 μs, with intensity adjusted to the maximum tolerable painless threshold). In addition to clinic visits, all participants are required to perform daily home-based PFMT. They will track their exercise frequency and compliance using a dedicated smartphone timer application. The study seeks to provide evidence for personalized clinical treatment decisions by analyzing which level of intervention yields the best symptom relief and quality of life improvement for different OAB phenotypes.