Treatment Efficacy for Overactive Bladder: Comparing Education, Biofeedback, and Nerve Stimulation | NCT07744620

NCT07744620

Overview

NCT ID: NCT07744620
Lead Sponsor: Far Eastern Memorial HospitalOTHER
Official Title: Efficacy of Treatments for Overactive Bladder Based on Pathophysiological Phenotypes: A Comparison of Verbal Education, Biofeedback-Assisted Pelvic Floor Muscle Training, and Combined Tibial Nerve Stimulation
Brief 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.

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Aug 4, 2026Actual
Start Date: Aug 3, 2026Estimated
Primary Completion Date: Jan 31, 2030Estimated

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

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).

Exclusion Criteria:

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.

Use of antimuscarinics (e.g., Oxybutynin, Tolterodine, Solifenacin) or beta-3 adrenergic receptor agonists (e.g., Mirabegron) within 2 weeks prior to study entry.

Receipt of pelvic or perineal physical therapy outside of this study protocol (e.g., vaginal or anal probe electrical stimulation, pelvic floor magnetic stimulation, transcutaneous microcurrent stimulation) within 2 weeks prior to study entry.

Receipt of intravesical Botulinum toxin (Botox) injections, sacral neuromodulation, or any surgical treatment related to urinary incontinence or pelvic organ prolapse within 2 weeks prior to study entry.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 201Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking

Contacts and Locations

Central Contacts: Ying Ju Liu, MDContact
easoneric0416@gmail.com

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