Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

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

30 april 2026 bijgewerkt door: KMUHIRB-F(I)-20230051

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.

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

60

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Taiwan
    • Taiwan
      • Kaohsiung, Taiwan, Taiwan, 807
        • Werving
        • Kaohsiung Medical University
        • Contact:
        • Contact:
        • Onderonderzoeker:
          • Jiun-Hung Geng, MD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: LiESWT Group
Participants receive low-energy extracorporeal shock wave therapy (LiESWT) applied to the bladder region.
Apparaat: 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.
Sham-vergelijker: Sham Control Group
Participants receive a sham procedure that mimics LiESWT without delivering therapeutic energy.
Apparaat: Sham Shock Wave Therapy
The device is applied in the same manner as the active treatment but does not emit therapeutic shock wave energy.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Overactive Bladder Symptom Score (OABSS)
Tijdsspanne: 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.
Baseline to 24 weeks

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)
Tijdsspanne: Baseline to 24 weeks
The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF; range 0-21, higher scores indicate worse symptoms).
Baseline to 24 weeks
Change in Urinary Distress Inventory (UDI-6)
Tijdsspanne: Baseline to 24 weeks
The Urinary Distress Inventory-6 (UDI-6; range 0-100, higher scores indicate greater symptom distress).
Baseline to 24 weeks
Change in maximum urinary flow rate measured by uroflowmetry (Qmax)
Tijdsspanne: Baseline to 24 weeks
Maximum urinary flow rate (Qmax, mL/s) will be assessed using standard uroflowmetry. Higher values indicate improved urinary flow function.
Baseline to 24 weeks
Change in post-void residual volume measured by bladder ultrasound (PVR)
Tijdsspanne: Baseline to 24 weeks
Post-void residual (PVR, mL) will be measured using bladder ultrasound immediately after voiding. Lower values indicate improved bladder emptying.
Baseline to 24 weeks
Change in voided volume per micturition assessed by 3-day voiding diary
Tijdsspanne: Baseline to 24 weeks
Voided volume (mL) will be calculated from a 3-day voiding diary. Higher values indicate improved bladder capacity.
Baseline to 24 weeks
Change in total daily urine volume assessed by 3-day voiding diary
Tijdsspanne: Baseline to 24 weeks
Total urine volume (mL/day) will be calculated from a 3-day voiding diary.
Baseline to 24 weeks
change in Incontinence Impact Questionnaire short version (IIQ-7)
Tijdsspanne: 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.
Baseline to 24 weeks

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence of treatment-related adverse events
Tijdsspanne: Baseline to 24 weeks
Adverse events will be recorded throughout the study period and classified according to severity and relationship to treatment.
Baseline to 24 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

KMUHIRB-F(I)-20230051

Onderzoekers

  • Hoofdonderzoeker: Yung-Chin Lee, MD,PHD, Kaohsiung Medical University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

10 februari 2025

Primaire voltooiing (Geschat)

30 juni 2026

Studie voltooiing (Geschat)

30 juni 2026

Studieregistratiedata

Eerst ingediend

23 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

30 april 2026

Eerst geplaatst (Werkelijk)

4 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

4 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

30 april 2026

Laatst geverifieerd

1 april 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • KMUHIRB-F(I)-20230051
  • KMUH-LiESWT-OAB-2023 (Andere identificatie: Kaohsiung Medical University Hospital)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

Data available upon reasonable request

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren