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

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

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

Treatments tested in this trial

  • Low-Energy Extracorporeal Shock Wave Therapy (LiESWT)
  • Sham Shock Wave Therapy

Treatment groups

60 Participants
are divided into 2 treatment groups

Locations

1

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

Kaohsiung medical universityRecruiting807, Kaohsiung, TaiwanTaiwanTaiwan

Sponsors and collaborators

KMUHIRB-F(I)-20230051

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Sponsor institution