An interventional study of Low-Energy Extracorporeal Shock Wave Therapy (LiESWT) and Sham Shock Wave Therapy in Bladder, Lower Urinary Track Symptoms and Metabolic Syndrome, sponsored by KMUHIRB-F(I)-20230051. Recruiting at 1 site in Taiwan. Open to female participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-05-04.
Sponsored by KMUHIRB-F(I)-20230051 · Not applicable, Interventional, and Treatment
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.
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.
2,116 studies on the registry are indexed under Metabolic Syndrome; 347 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 1,572 interventional studies indexed under Metabolic Syndrome.
Browse Metabolic Syndrome studies →This is the only study on the registry with KMUHIRB-F(I)-20230051 as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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Exclusion:
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Participants receive low-energy extracorporeal shock wave therapy (LiESWT) applied to the bladder region.
Device: Low-Energy Extracorporeal Shock Wave Therapy (LiESWT)
Participants receive a sham procedure that mimics LiESWT without delivering therapeutic energy.
Device: Sham Shock Wave Therapy
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.
The device is applied in the same manner as the active treatment but does not emit therapeutic shock wave energy.
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.
Time frame: Baseline to 24 weeks
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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 24 weeks
Incidence of treatment-related adverse events
Adverse events will be recorded throughout the study period and classified according to severity and relationship to treatment.
Time frame: Baseline to 24 weeks
Plan to share: No — Data available upon reasonable request
No publications or documents are linked to this record.
Started Feb 2025 (actual). Primary completion is estimated for Jun 2026, 16 months after the start.
Of 625 non-industry interventional studies with no phase under Metabolic Syndrome, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 41. This study's planned 16 months is below that.
Counting every sponsor, half of 675 studies reached it within 20 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
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