Treatment Efficacy for Overactive Bladder: Comparing Education, Biofeedback, and Nerve Stimulation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20+
SponsorFar Eastern Memorial Hospital
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Behavioral
BehavioralParticipants 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.
Enraf-Nonius EMG-Biofeedback Unit (Biofeedback only)
DeviceParticipants 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.
Enraf-Nonius EMG-Biofeedback Unit (Biofeedback + Electrical Stimulation)
DeviceParticipants 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.
Treatment groups
201 Participants
are divided into 3 treatment groupsGroup A: Oral Education PFMTActive comparator 1 intervention
Group B: Biofeedback-assisted PFMTExperimental treatment 1 intervention
Group C: Biofeedback PFMT + Tibial Nerve StimulationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (Week 0), Week 2, Week 4, and Week 82
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.
Time frame
Baseline (Week 0) and Week 8Secondary outcomes
1
Change in Overactive Bladder Questionnaire (OAB-q) Score
Pelvic floor muscle function will be assessed using the biofeedback device to measure vaginal pressure or by manual muscle testing (MMT) to evaluate the change in pelvic floor muscle strength.
Time frame
Baseline (Week 0), Week 2, Week 4, and Week 82
Change in King's Health Questionnaire (KHQ) Score
This questionnaire evaluates the impact of urinary incontinence on the physical, psychological, and social dimensions of the participants' health-related quality of life.
Time frame
Baseline (Week 0), Week 2, Week 4, and Week 83
Subjective Symptom Improvement Rating
A patient-reported outcome measure where participants subjectively score their overall degree of symptom relief throughout the intervention period
Time frame
Baseline (Week 0), Week 2, Week 4, and Week 84
Change in Pelvic Floor Muscle Strength
Pelvic floor muscle function will be objectively assessed using the biofeedback device to measure vaginal pressure or by manual muscle testing (MMT) to evaluate the change in muscle strength.
Time frame
Baseline (Week 0), Week 2, Week 4, and Week 8Locations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Far Eastern Memorial Hospital Status unavailable Taiwan, New Taipei City, Taiwan
Taiwan
TaiwanSponsors and contacts
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Source ClinicalTrials.gov
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