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

Summary

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.

Conditions

• Urinary Bladder, Overactive
• Urinary Incontinence, Urge

Interventions

BEHAVIORAL

Behavioral

Participants receive standard oral education on Pelvic Floor Muscle Training (PFMT). They are instructed to perform daily home-based pelvic floor exercises and track their compliance and exercise frequency using a smartphone timer application. Clinical assessments and educational reinforcements are conducted at weeks 0, 2, 4, and 8.

DEVICE

Enraf-Nonius EMG-Biofeedback Unit (Biofeedback only)

Participants undergo biofeedback-assisted Pelvic Floor Muscle Training (PFMT) using the Enraf-Nonius EMG-Biofeedback Unit. During clinic visits at weeks 0, 2, 4, and 8, the device is used to assist patients in accurately identifying and contracting the correct pelvic floor muscles. In addition to clinic sessions, participants perform and track daily home-based PFMT.

DEVICE

Enraf-Nonius EMG-Biofeedback Unit (Biofeedback + Electrical Stimulation)

Participants receive biofeedback-assisted PFMT combined with percutaneous tibial nerve electrical stimulation using the Enraf-Nonius device. During clinic visits at weeks 0, 2, 4, and 8, patients receive a 30 to 40-minute session of electrical stimulation (parameters: 20 Hz, 200 μs, with intensity progressively adjusted to the maximum tolerable painless threshold). Participants also perform and track daily home-based PFMT.

Sponsors & Collaborators

• Far Eastern Memorial Hospital

  lead OTHER

Principal Investigators

• Wen Yih Wu, MD · Far Eastern Memorial Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

20 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-08-03

Primary Completion

2030-01-31

Completion

2030-04-30

Countries

• Taiwan