An interventional study of Behavioral and Enraf-Nonius EMG-Biofeedback Unit (Biofeedback only) in Urinary Bladder, Overactive and Urinary Incontinence, Urge, sponsored by Far Eastern Memorial Hospital. Not yet recruiting at 1 site in Taiwan. Open to female participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-08-04.
Sponsored by Far Eastern Memorial Hospital · Not applicable, Interventional, and Treatment
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.
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.
858 studies on the registry are indexed under Urinary Bladder, Overactive; 127 are open to participants now.
This study's planned enrollment of 201 is above the median of 70 across 649 interventional studies indexed under Urinary Bladder, Overactive.
Browse Urinary Bladder, Overactive studies →Far Eastern Memorial Hospital is the lead sponsor of 260 studies on the registry; 40 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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)
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)
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.
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.
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.
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 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.
Time frame: Baseline (Week 0) and Week 8
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 8
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 8
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 8
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 8
Change in PFMT Self-Efficacy and Home Exercise Compliance
This measure quantifies patients' psychological readiness and persistence in performing pelvic floor muscle training (PFMT). It is combined with the objective monitoring of their daily home exercise frequency, which is tracked using a smartphone timer application.
Time frame: Baseline (Week 0), Week 2, Week 4, and Week 8
Plan to share: No
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Start is estimated for Aug 2026; primary completion for Jan 2030, 41 months later.
Of 133 non-industry interventional studies with no phase under Urinary Bladder, Overactive, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 40. This study's planned 41 months is above that.
Counting every sponsor, half of 174 studies reached it within 19 months; a quarter within 10 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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