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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Устройство 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.
• Устройство 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.

Первичные конечные точки

• Change in Overactive Bladder Symptom Score (OABSS) [Срок оценки: Baseline (Week 0), Week 2, Week 4, and Week 8]
• Change in 3-day Bladder Diary Parameters [Срок оценки: Baseline (Week 0) and Week 8]

Вторичные конечные точки (5)

• Change in Overactive Bladder Questionnaire (OAB-q) Score [Срок оценки: Baseline (Week 0), Week 2, Week 4, and Week 8]
• Change in King's Health Questionnaire (KHQ) Score [Срок оценки: Baseline (Week 0), Week 2, Week 4, and Week 8]
• Subjective Symptom Improvement Rating [Срок оценки: Baseline (Week 0), Week 2, Week 4, and Week 8]
• Change in Pelvic Floor Muscle Strength [Срок оценки: Baseline (Week 0), Week 2, Week 4, and Week 8]
• Change in PFMT Self-Efficacy and Home Exercise Compliance [Срок оценки: Baseline (Week 0), Week 2, Week 4, and Week 8]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Тайвань · 1 центр

• Far Eastern Memorial Hospital — New Taipei City

Идентификаторы

NCT: NCT07744620 · 115137-F

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗