Bladder, Bladder, Overactive, Lower Urinary Track Symptoms, Metabolic Syndrome, Urgency-Frequency
Conditions
Keywords
Low-energy extracorporeal shock wave therapy, LiESWT, Overactive bladder, Metabolic syndrome, Urinary urgency, Urinary frequency, Nocturia, Randomized controlled trial
Brief 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. 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.
Interventions
DEVICELow-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.
DEVICESham Shock Wave Therapy
The device is applied in the same manner as the active treatment but does not emit therapeutic shock wave energy.
Sponsors
KMUHIRB-F(I)-20230051
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Participants, care providers, and investigators are blinded to group allocation. The sham procedure mimics the active treatment without delivering therapeutic energy.
Intervention model description
Participants are randomly assigned to either the LiESWT treatment group or a sham control group in a parallel design.
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Inclusion: * 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 * 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 Exclusion: * 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Overactive Bladder Symptom Score (OABSS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) | Baseline to 24 weeks | The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF; range 0-21, higher scores indicate worse symptoms). |
| Change in Urinary Distress Inventory (UDI-6) | Baseline to 24 weeks | The Urinary Distress Inventory-6 (UDI-6; range 0-100, higher scores indicate greater symptom distress). |
| Change in maximum urinary flow rate measured by uroflowmetry (Qmax) | Baseline to 24 weeks | Maximum urinary flow rate (Qmax, mL/s) will be assessed using standard uroflowmetry. Higher values indicate improved urinary flow function. |
| Change in post-void residual volume measured by bladder ultrasound (PVR) | Baseline to 24 weeks | Post-void residual (PVR, mL) will be measured using bladder ultrasound immediately after voiding. Lower values indicate improved bladder emptying. |
| Change in voided volume per micturition assessed by 3-day voiding diary | Baseline to 24 weeks | Voided volume (mL) will be calculated from a 3-day voiding diary. Higher values indicate improved bladder capacity. |
| Change in total daily urine volume assessed by 3-day voiding diary | Baseline to 24 weeks | Total urine volume (mL/day) will be calculated from a 3-day voiding diary. |
| change in Incontinence Impact Questionnaire short version (IIQ-7) | Baseline to 24 weeks | 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. |
Countries
Taiwan
Contacts
CONTACTJIUNHUNG GENG, MD
CONTACTYung-Chin Lee, MD, PHD
PRINCIPAL_INVESTIGATORYung-Chin Lee, MD,PHD
Kaohsiung Medical University
Outcome results
None listed