Urinary Bladder, OveractiveNCT07744620
Treatment Efficacy for Overactive Bladder: Comparing Education, Biofeedback, and Nerve Stimulation
A study testing Behavioral, Enraf-Nonius EMG-Biofeedback Unit (Biofeedback only) and Enraf-Nonius EMG-Biofeedback Unit (Biofeedback + Electrical Stimulation) in people with Urinary Bladder, Overactive and Urinary Incontinence, Urge, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Urinary Bladder, Overactive, Urinary Incontinence, Urge
- What is being tested?
- Behavioral, Enraf-Nonius EMG-Biofeedback Unit (Biofeedback only) and Enraf-Nonius EMG-Biofeedback Unit (Biofeedback + Electrical Stimulation)
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 Aug 2026to 30 Apr 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Far Eastern Memorial Hospital
New Taipei City, Taiwan, Taiwan
Wen-Yi Wu, MD, +886-2-8966-7000 ext. 1813, wenyih@gmail.com
About this study
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
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.
Read the detailed description
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.
- Being tested
- Behavioral, Enraf-Nonius EMG-Biofeedback Unit (Biofeedback only), Enraf-Nonius EMG-Biofeedback Unit (Biofeedback + Electrical Stimulation)
- Keywords
- Overactive Bladder (OAB), Pelvic Floor Muscle Training (PFMT), Biofeedback, Tibial Nerve Stimulation, Neuromodulation, Electrical Stimulation
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BehavioralBehavioural
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.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: Enraf-Nonius EMG-Biofeedback Unit (Biofeedback + Electrical Stimulation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (Week 0) and Week 8
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Baseline (Week 0), Week 2, Week 4, and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start3 Aug 2026 (estimated)
- Primary completion31 Jan 2030 (estimated)
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Bladder, OveractiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are stratified by OAB phenotype (wet or dry) and randomly assigned to one of three parallel treatment groups for an 8-week intervention.
- Masking
- None (open label)
- Enrolment
- 201 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wen Yih Wu, MD, Principal investigator, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07744620
- Sponsor's protocol ID
- 115137-F
- Status last verified
- Jul 2026
- First submitted
- 30 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07744620
- Acronym / sponsor ID
- 115137-F
- Keywords
- Overactive Bladder (OAB), Pelvic Floor Muscle Training (PFMT), Biofeedback, Tibial Nerve Stimulation, Neuromodulation, Electrical Stimulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 201 participants (estimated)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 3 Aug 2026 (estimated)
- Primary completion
- 31 Jan 2030 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 4 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants are stratified by OAB phenotype (wet or dry) and randomly assigned to one of three parallel treatment groups for an 8-week intervention.
| Arm | Type | Receives |
|---|---|---|
| Oral Education PFMT | Active comparator | Behavioral: BehavioralParticipants 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. |
| Biofeedback-assisted PFMT | Experimental | Device: Enraf-Nonius EMG-Biofeedback Unit (Biofeedback only)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. |
| Biofeedback PFMT + Tibial Nerve Stimulation | Experimental | Device: Enraf-Nonius EMG-Biofeedback Unit (Biofeedback + Electrical Stimulation)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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Oral Education PFMT |
| 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. | Device | Biofeedback-assisted PFMT |
| 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. | Device | Biofeedback PFMT + Tibial Nerve Stimulation |
Primary outcome
Change in Overactive Bladder Symptom Score (OABSS)
Time frame: Baseline (Week 0), Week 2, Week 4, and Week 8
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.
Change in 3-day Bladder Diary Parameters
Time frame: Baseline (Week 0) and Week 8
Participants will record their voiding habits over a 72-hour period, including fluid intake, number of micturitions (frequency), and number of urinary incontinence episodes.
5 secondary outcomes
Change in Overactive Bladder Questionnaire (OAB-q) Score
Time frame: Baseline (Week 0), Week 2, Week 4, and Week 8
Change in King's Health Questionnaire (KHQ) Score
Time frame: Baseline (Week 0), Week 2, Week 4, and Week 8
Subjective Symptom Improvement Rating
Time frame: Baseline (Week 0), Week 2, Week 4, and Week 8
Change in Pelvic Floor Muscle Strength
Time frame: Baseline (Week 0), Week 2, Week 4, and Week 8
Change in PFMT Self-Efficacy and Home Exercise Compliance
Time frame: Baseline (Week 0), Week 2, Week 4, and Week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wen Yih Wu, MD principal investigator
Far Eastern Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral, Enraf-Nonius EMG-Biofeedback Unit (Biofeedback only) and Enraf-Nonius EMG-Biofeedback Unit (Biofeedback + Electrical Stimulation) in people with Urinary Bladder, Overactive and Urinary Incontinence, Urge, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ying Ju Liu, MD (+886-2-89667000 ext. 4449, easoneric0416@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Overactive Bladder Symptom Score (OABSS) (time frame: Baseline (Week 0), Week 2, Week 4, and Week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.