BladderNCT07563764
Low-Energy Shock Wave Therapy for Overactive Bladder in Women With Metabolic Syndrome
A study testing Low-Energy Extracorporeal Shock Wave Therapy (LiESWT) in people with Bladder and Lower Urinary Track Symptoms, run by KMUHIRB-F(I)-20230051 at 1 site in Taiwan.
Trial summary
Overactive bladder (OAB) is a common condition that causes urinary urgency, frequent urination, and nocturia, which can significantly affect quality of life. Women with metabolic syndrome may have a higher risk of OAB due to vascular and metabolic abnormalities. Read more about this study
- Who is it for?
- Ages 20 to 75 years, women only
- Conditions the study is for
- Bladder, Lower Urinary Track Symptoms, Metabolic Syndrome
- What is being tested?
- Low-Energy Extracorporeal Shock Wave Therapy (LiESWT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Feb 2025to 30 Jun 2026
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female participants aged 20 to 75 years
- Diagnosed with overactive bladder (OAB), defined as urinary frequency (≥8 times/day), nocturia (≥2 times/night), and urgency (≥2 episodes/week) for at least 3 months
- Diagnosed with metabolic syndrome, defined by the presence of at least three of the following criteria:
- Waist circumference ≥80 cm
- Blood pressure ≥130/85 mmHg or receiving antihypertensive treatment
- Fasting glucose ≥100 mg/dL or receiving treatment for diabetes
Show all 11Show fewer
- Triglycerides ≥150 mg/dL or receiving lipid-lowering treatment
- High-density lipoprotein cholesterol <50 mg/dL
- No pharmacological or injection treatment for OAB within 3 months prior to enrollment
- Able to understand and comply with study procedures and questionnaires
- Willing to provide informed consent
Who cannot join
- History of kidney stones or bladder stones
- Urinary tract infection within 3 months prior to enrollment or recurrent urinary tract infections (≥3 episodes)
- Lower urinary tract surgery within 6 months prior to enrollment
- Known or suspected malignancy of the urinary tract
- Significant bladder outlet obstruction
- Severe coagulopathy, liver failure, or renal failure
Show all 11Show fewer
- Prior pelvic malignancy or pelvic radiation therapy
- Intravesical injection or electrical stimulation therapy within the past year
- Substance abuse (drug or alcohol) within the past year
- Chronic pelvic pain due to other causes
- Inability to complete study questionnaires or procedures
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, 1 recruiting
- Recruiting
Kaohsiung medical university
Kaohsiung, Taiwan, 807
JIUNHUNG GENG, MD, +88673121101 ext 6694, u9001090@hotmail.com
Yung-Chin Lee, MD,PHD, +88673121101, leeyc12345@yahoo.com.tw
About this study
Official title: A Randomized, Double-Blind, Sham-Controlled Trial of Low-Energy Extracorporeal Shock Wave Therapy for Overactive Bladder in Women With Metabolic Syndrome
Overactive bladder (OAB) is a common condition that causes urinary urgency, frequent urination, and nocturia, which can significantly affect quality of life. Women with metabolic syndrome may have a higher risk of OAB due to vascular and metabolic abnormalities.
This study aims to evaluate the effectiveness and safety of low-energy extracorporeal shock wave therapy (LiESWT), a non-invasive treatment, in women with metabolic syndrome-associated OAB. Participants will be randomly assigned to receive either active LiESWT treatment or a sham (inactive) procedure.
Read more
Symptoms and treatment outcomes will be assessed using validated questionnaires, including the Overactive Bladder Symptom Score (OABSS), International Consultation on Incontinence Questionnaire (ICIQ-SF), Urinary Distress Inventory (UDI-6), and Incontinence Impact Questionnaire (IIQ-7), as well as a voiding diary and uroflow measurements.
The results of this study may help determine whether LiESWT is an effective treatment option for improving OAB symptoms in this patient population.
Read the detailed description
Overactive bladder (OAB) is a prevalent urological condition characterized by urinary urgency, frequency, and nocturia, which significantly impairs quality of life. Emerging evidence suggests a strong association between OAB and metabolic syndrome, which is characterized by insulin resistance, hypertension, dyslipidemia, and central obesity. These metabolic abnormalities may contribute to endothelial dysfunction, chronic inflammation, and autonomic dysregulation, potentially affecting bladder function.
Low-energy extracorporeal shock wave therapy (LiESWT) is a novel, non-invasive therapeutic modality that has been shown to promote angiogenesis, improve tissue perfusion, and modulate inflammatory responses. Previous studies have demonstrated its potential benefits in various urological conditions.
This study is designed as a randomized, double-blind, sham-controlled trial to evaluate the efficacy and safety of LiESWT in women with metabolic syndrome-associated OAB. Participants are randomly assigned to receive either LiESWT treatment or a sham procedure.
Clinical outcomes are assessed using validated patient-reported outcome measures, including OABSS, ICIQ-SF, UDI-6, and IIQ-7, along with objective parameters such as uroflowmetry and post-void residual volume. Assessments are performed at baseline and at multiple follow-up time points after treatment.
This study aims to provide clinical evidence on the therapeutic role of LiESWT in improving symptoms and quality of life in this specific patient population.
- Conditions
- Bladder, Lower Urinary Track Symptoms, Metabolic Syndrome, Urgency-Frequency, Bladder, Overactive
- Being tested
- Low-Energy Extracorporeal Shock Wave Therapy (LiESWT), Sham Shock Wave Therapy
- Keywords
- Low-energy extracorporeal shock wave therapy, LiESWT, Overactive bladder, Metabolic syndrome, Urinary urgency, Urinary frequency, Nocturia, Randomized controlled trial
- Medical subject headings
- Metabolic Syndrome, Urinary Bladder, Overactive, Nocturia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Energy Extracorporeal Shock Wave Therapy (LiESWT)Device
LiESWT is delivered using a focused shock wave device at an energy flux density of 0.25 mJ/mm², frequency of 3 Hz, and 3,000 pulses per session.
Sham Shock Wave TherapyDevice
The device is applied in the same manner as the active treatment but does not emit therapeutic shock wave energy.
| Study group | Role | What they receive |
|---|---|---|
| LiESWT Group | Experimental | Participants receive low-energy extracorporeal shock wave therapy (LiESWT) applied to the bladder region. Receives: Device: Low-Energy Extracorporeal Shock Wave Therapy (LiESWT) |
| Sham Control Group | Sham comparator | Participants receive a sham procedure that mimics LiESWT without delivering therapeutic energy. Receives: Device: Sham Shock Wave Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Overactive Bladder Symptom Score (OABSS)
The Overactive Bladder Symptom Score (OABSS; range 0-15, with higher scores indicating more severe symptoms) will be used. The primary outcome is the change in OABSS from baseline to 4, 8, 12, 16, 20, 24 weeks after treatment. Lower scores indicate improvement in symptoms.
Measured: Baseline to 24 weeks
Secondary outcomes (7)
Change in International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)
The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF; range 0-21, higher scores indicate worse symptoms).
Measured: Baseline to 24 weeks
Change in Urinary Distress Inventory (UDI-6)
The Urinary Distress Inventory-6 (UDI-6; range 0-100, higher scores indicate greater symptom distress).
Measured: Baseline to 24 weeks
Change in maximum urinary flow rate measured by uroflowmetry (Qmax)
Maximum urinary flow rate (Qmax, mL/s) will be assessed using standard uroflowmetry. Higher values indicate improved urinary flow function.
Measured: Baseline to 24 weeks
Change in post-void residual volume measured by bladder ultrasound (PVR)
Post-void residual (PVR, mL) will be measured using bladder ultrasound immediately after voiding. Lower values indicate improved bladder emptying.
Measured: Baseline to 24 weeks
Change in voided volume per micturition assessed by 3-day voiding diary
Voided volume (mL) will be calculated from a 3-day voiding diary. Higher values indicate improved bladder capacity.
Measured: Baseline to 24 weeks
Change in total daily urine volume assessed by 3-day voiding diary
Total urine volume (mL/day) will be calculated from a 3-day voiding diary.
Measured: Baseline to 24 weeks
change in Incontinence Impact Questionnaire short version (IIQ-7)
The IIQ-7 uses a 0-3 scale to measure how urinary incontinence impacts household chores, physical recreation, entertainment, travel, social activities, emotional health, and feelings of frustration to determine an overall quality-of-life score.
Measured: Baseline to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start10 Feb 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BladderStudies 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 randomly assigned to either the LiESWT treatment group or a sham control group in a parallel design.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KMUHIRB-F(I)-20230051
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, KMUHIRB-F(I)-20230051, Kaohsiung Medical University Chung-Ho Memorial Hospital
- Investigators
- Yung-Chin Lee, MD,PHD, Principal investigator, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07563764
- Sponsor's protocol ID
- KMUHIRB-F(I)-20230051
- Other IDs
- KMUH-LiESWT-OAB-2023
- Status last verified
- Apr 2026
- First submitted
- 23 Apr 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data available upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Sham-Controlled Trial of Low-Energy Extracorporeal Shock Wave Therapy for Overactive Bladder in Women With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT07563764
- Acronym / sponsor ID
- KMUHIRB-F(I)-20230051
- Conditions
- Bladder, Lower Urinary Track Symptoms, Metabolic Syndrome, Urgency-Frequency, Bladder, Overactive
- Keywords
- Low-energy extracorporeal shock wave therapy, LiESWT, Overactive bladder, Metabolic syndrome, Urinary urgency, Urinary frequency, Nocturia, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- KMUHIRB-F(I)-20230051University, hospital or other
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 4 May 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.
Overactive bladder (OAB) is a common condition that causes urinary urgency, frequent urination, and nocturia, which can significantly affect quality of life. Women with metabolic syndrome may have a higher risk of OAB due to vascular and metabolic abnormalities.
This study aims to evaluate the effectiveness and safety of low-energy extracorporeal shock wave therapy (LiESWT), a non-invasive treatment, in women with metabolic syndrome-associated OAB. Participants will be randomly assigned to receive either active LiESWT treatment or a sham (inactive) procedure.
Symptoms and treatment outcomes will be assessed using validated questionnaires, including the Overactive Bladder Symptom Score (OABSS), International Consultation on Incontinence Questionnaire (ICIQ-SF), Urinary Distress Inventory (UDI-6), and Incontinence Impact Questionnaire (IIQ-7), as well as a voiding diary and uroflow measurements.
The results of this study may help determine whether LiESWT is an effective treatment option for improving OAB symptoms in this patient population.
Detailed description
Overactive bladder (OAB) is a prevalent urological condition characterized by urinary urgency, frequency, and nocturia, which significantly impairs quality of life. Emerging evidence suggests a strong association between OAB and metabolic syndrome, which is characterized by insulin resistance, hypertension, dyslipidemia, and central obesity. These metabolic abnormalities may contribute to endothelial dysfunction, chronic inflammation, and autonomic dysregulation, potentially affecting bladder function.
Low-energy extracorporeal shock wave therapy (LiESWT) is a novel, non-invasive therapeutic modality that has been shown to promote angiogenesis, improve tissue perfusion, and modulate inflammatory responses. Previous studies have demonstrated its potential benefits in various urological conditions.
This study is designed as a randomized, double-blind, sham-controlled trial to evaluate the efficacy and safety of LiESWT in women with metabolic syndrome-associated OAB. Participants are randomly assigned to receive either LiESWT treatment or a sham procedure.
Clinical outcomes are assessed using validated patient-reported outcome measures, including OABSS, ICIQ-SF, UDI-6, and IIQ-7, along with objective parameters such as uroflowmetry and post-void residual volume. Assessments are performed at baseline and at multiple follow-up time points after treatment.
This study aims to provide clinical evidence on the therapeutic role of LiESWT in improving symptoms and quality of life in this specific patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to either the LiESWT treatment group or a sham control group in a parallel design.
| Arm | Type | Receives |
|---|---|---|
| LiESWT Group | Experimental | Device: Low-Energy Extracorporeal Shock Wave Therapy (LiESWT)Participants receive low-energy extracorporeal shock wave therapy (LiESWT) applied to the bladder region. |
| Sham Control Group | Sham comparator | Device: Sham Shock Wave TherapyParticipants receive a sham procedure that mimics LiESWT without delivering therapeutic energy. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Female participants aged 20 to 75 years
- Diagnosed with overactive bladder (OAB), defined as urinary frequency (≥8 times/day), nocturia (≥2 times/night), and urgency (≥2 episodes/week) for at least 3 months
- Diagnosed with metabolic syndrome, defined by the presence of at least three of the following criteria:
- Waist circumference ≥80 cm
- Blood pressure ≥130/85 mmHg or receiving antihypertensive treatment
Key exclusion criteria (11 listed)
- History of kidney stones or bladder stones
- Urinary tract infection within 3 months prior to enrollment or recurrent urinary tract infections (≥3 episodes)
- Lower urinary tract surgery within 6 months prior to enrollment
- Known or suspected malignancy of the urinary tract
- Significant bladder outlet obstruction
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 |
|---|---|---|
| Low-Energy Extracorporeal Shock Wave Therapy (LiESWT)LiESWT is delivered using a focused shock wave device at an energy flux density of 0.25 mJ/mm², frequency of 3 Hz, and 3,000 pulses per session. | Device | LiESWT Group |
| Sham Shock Wave TherapyThe device is applied in the same manner as the active treatment but does not emit therapeutic shock wave energy. | Device | Sham Control Group |
Primary outcome
Change in Overactive Bladder Symptom Score (OABSS)
Time frame: Baseline to 24 weeks
The Overactive Bladder Symptom Score (OABSS; range 0-15, with higher scores indicating more severe symptoms) will be used. The primary outcome is the change in OABSS from baseline to 4, 8, 12, 16, 20, 24 weeks after treatment. Lower scores indicate improvement in symptoms.
7 secondary outcomes
Change in International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)
Time frame: Baseline to 24 weeks
Change in Urinary Distress Inventory (UDI-6)
Time frame: Baseline to 24 weeks
Change in maximum urinary flow rate measured by uroflowmetry (Qmax)
Time frame: Baseline to 24 weeks
Change in post-void residual volume measured by bladder ultrasound (PVR)
Time frame: Baseline to 24 weeks
Change in voided volume per micturition assessed by 3-day voiding diary
Time frame: Baseline to 24 weeks
Change in total daily urine volume assessed by 3-day voiding diary
Time frame: Baseline to 24 weeks
change in Incontinence Impact Questionnaire short version (IIQ-7)
Time frame: Baseline to 24 weeks
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 May 2026.
- Individual participant dataSharing planned: No. Data available upon reasonable request
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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.
Yung-Chin Lee, MD,PHD principal investigator
Kaohsiung Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Energy Extracorporeal Shock Wave Therapy (LiESWT) in people with Bladder and Lower Urinary Track Symptoms, run by KMUHIRB-F(I)-20230051 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 11 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 4 May 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. Some participants in this study may receive a placebo. 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 JIUNHUNG GENG, MD (+88673121101 ext.6694, u9001090@hotmail.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 to 24 weeks). 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 May 2026.