Health TrialsbyHealthPanel

Low-Energy Shock Wave Therapy for Overactive Bladder in Women With Metabolic Syndrome

ConditionsBladderLower Urinary Track SymptomsMetabolic SyndromeUrgency-FrequencyBladder, Overactive
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-75
SponsorKMUHIRB-F(I)-20230051

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Waist circumference ≥80 cm

Blood pressure ≥130/85 mmHg or receiving antihypertensive treatment

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 Therapy

    Device

    The device is applied in the same manner as the active treatment but does not emit therapeutic shock wave energy.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: LiESWT GroupExperimental treatment 1 intervention
Group B: Sham Control GroupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

1

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

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Kaohsiung medical universityRecruiting807, Kaohsiung, TaiwanTaiwanTaiwan

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

KMUHIRB-F(I)-20230051

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Sponsor institution

Source ClinicalTrials.gov
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