About this trial
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.
Eligibility criteria
Qualifiers
Stable on chronic medications: Participants must have been on a long-term, regular regimen of routine medications for chronic conditions (e.g., hypertension, diabetes, hyperlipidemia) prior to study entry, with no expected changes in dosage or administration during the 8-week study period.
Diagnosed with Overactive Bladder (OAB) according to the International Continence Society (ICS) definition, including urgency, frequency, and nocturia, with or without urgency urinary incontinence (must be documented as OAB-wet or OAB-dry).
Symptoms persisting for at least 3 months.
Overactive Bladder Symptom Score (OABSS) total score ≥ 3 at baseline (Week 0), with an urgency score (Question 3) ≥ 2 (meeting the clinical threshold for core OAB symptom intensity).
Disqualifiers
Concurrent active urinary tract infection (UTI), bladder stones, or urinary tract malignancy.
Inability to follow instructions for muscle training due to cognitive impairment or severe psychiatric illness.
Presence of implanted electronic medical devices (e.g., cardiac pacemakers) (contraindication for electrical stimulation).
Currently pregnant women or those planning to become pregnant during the study period.
Trial design
Treatments tested in this trial
- Behavioral
- Enraf-Nonius EMG-Biofeedback Unit (Biofeedback only)
- Enraf-Nonius EMG-Biofeedback Unit (Biofeedback + Electrical Stimulation)
Treatment groups
Locations
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