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

NCT07744620 | Not Yet Recruiting DMC

• 1 other identifier: 115137-F
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Bladder, Overactive; Urinary Incontinence, Urge

Keywords

Overactive Bladder (OAB); Pelvic Floor Muscle Training (PFMT); Biofeedback; Tibial Nerve Stimulation; Neuromodulation; Electrical Stimulation

Outcome Measures

Primary Outcomes (2)

• Change in Overactive Bladder Symptom Score (OABSS)

  he OABSS is a validated, self-administered questionnaire used as a core clinical scale to evaluate the severity of overactive bladder symptoms. It consists of four items: daytime frequency, nighttime frequency, urgency, and urgency incontinence. The total score is calculated by summing the scores of the four items, with a higher total score indicating more severe OAB symptoms. The primary endpoint will evaluate the change in the total score from baseline to the end of the 8-week intervention.

  Baseline (Week 0), Week 2, Week 4, and Week 8

• Change in 3-day Bladder Diary Parameters

  Participants will record their voiding habits over a 72-hour period, including fluid intake, number of micturitions (frequency), and number of urinary incontinence episodes.

  Baseline (Week 0) and Week 8

Secondary Outcomes (5)

• Change in Overactive Bladder Questionnaire (OAB-q) Score

  Baseline (Week 0), Week 2, Week 4, and Week 8

• Change in King's Health Questionnaire (KHQ) Score

  Baseline (Week 0), Week 2, Week 4, and Week 8

• Subjective Symptom Improvement Rating

  Baseline (Week 0), Week 2, Week 4, and Week 8

• Change in Pelvic Floor Muscle Strength

  Baseline (Week 0), Week 2, Week 4, and Week 8

• Change in PFMT Self-Efficacy and Home Exercise Compliance

  Baseline (Week 0), Week 2, Week 4, and Week 8

Study Arms (3)

Oral Education PFMT

ACTIVE COMPARATOR

Participants receive 8 weeks of standard oral education on Pelvic Floor Muscle Training (PFMT). They are required to perform daily home-based PFMT and track their exercise frequency using a smartphone app. Clinic visits are scheduled at weeks 0, 2, 4, and 8.

Behavioral: Behavioral

Biofeedback-assisted PFMT

EXPERIMENTAL

Participants receive 8 weeks of biofeedback-assisted PFMT to improve muscle contraction accuracy using the Enraf-Nonius EMG-Biofeedback Unit. They also perform and track daily home-based PFMT. Clinic visits are scheduled at weeks 0, 2, 4, and 8.

Device: Enraf-Nonius EMG-Biofeedback Unit (Biofeedback only)

Biofeedback PFMT + Tibial Nerve Stimulation

EXPERIMENTAL

Participants receive 8 weeks of biofeedback-assisted PFMT combined with 30-40 minutes of tibial nerve electrical stimulation using the Enraf-Nonius unit per clinic visit. They also perform and track daily home-based PFMT. Clinic visits are scheduled at weeks 0, 2, 4, and 8.

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

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.

Oral Education PFMT

Enraf-Nonius EMG-Biofeedback Unit (Biofeedback only) DEVICE

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.

Biofeedback-assisted PFMT

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

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.

Biofeedback PFMT + Tibial Nerve Stimulation

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Far Eastern Memorial Hospital: lead

Study Sites (1)

Far Eastern Memorial Hospital

New Taipei City, Taiwan, Taiwan, Taiwan

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence, Urge

Interventions

Biofeedback, Psychology; Electric Stimulation

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Incontinence; Urination Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological; Physical Stimulation; Investigative Techniques

Study Officials

• Wen Yih Wu, MD

  Far Eastern Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying Ju Liu, MD

CONTACT

+886-2-89667000; easoneric0416@gmail.com

Wen Yih Wu, MD

CONTACT

+886-2-89667000; wenyih@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are stratified by OAB phenotype (wet or dry) and randomly assigned to one of three parallel treatment groups for an 8-week intervention.

Study Record Dates

• First Submitted: July 30, 2026
• First Posted: August 4, 2026
• Study Start: August 3, 2026
• Primary Completion (Estimated): January 31, 2030
• Study Completion (Estimated): April 30, 2030
• Last Updated: August 4, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)