Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Effectiveness of Chinese Herbal Medicine for Older Adults With Urinary Incontinence

5. juni 2026 oppdatert av: John Yang, Kwantlen Polytechnic University

Effectiveness of Chinese Herbal Medicine for Older Adults With Urinary Incontinence: A Randomized Double-Blind Placebo-Controlled Clinical Trial

This study aims to evaluate the effectiveness and safety of Chinese herbal medicine in improving urinary incontinence symptoms among older adults. Urinary incontinence is a common condition in aging populations that can significantly impact quality of life, yet existing treatments are often limited by side effects or insufficient efficacy.

The primary research question is whether a standardized Chinese herbal formula can reduce the frequency and severity of urinary incontinence compared to a placebo. We hypothesize that participants receiving the herbal intervention will demonstrate greater improvement in urinary symptoms and quality of life measures than those receiving placebo, without significant adverse effects.

To test this hypothesis, a randomized, double-blind, placebo-controlled clinical trial will be conducted. Eligible older adults will be randomly assigned to receive either the herbal treatment or a matched placebo over a defined study period. Outcomes will include validated measures of urinary incontinence severity, frequency of episodes, and patient-reported quality of life.

Potential benefits of this research include generating high-quality evidence on the effectiveness and safety of Chinese herbal medicine for urinary incontinence, which may inform clinical practice and expand treatment options for older adults. If effective, this intervention could offer a complementary or alternative approach with fewer side effects, contributing to improved symptom management and overall well-being in this population.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

150

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Canada
    • British Columbia
      • Richmond, British Columbia, Canada, V6X 3X7
        • Student Traditional Chinese Medicine Clinic

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • Experience symptoms of urinary incontinence (including stress, urge, or mixed incontinence) as confirmed by clinical assessment or validated screening tools.
  • Able to understand the study procedures and provide informed consent.
  • Willing and able to comply with study requirements, including attending study visits, and completing questionnaires.
  • Stable general medical condition that, in the opinion of the investigator, does not interfere with participation in the study.
  • Not currently participating in another interventional clinical trial that could affect urinary incontinence outcomes.

Exclusion Criteria:

  • Inability to provide informed consent due to severe cognitive impairment or dementia.
  • Known allergy or hypersensitivity to any component of the Chinese herbal medicine formulation.
  • Presence of severe, unstable, or uncontrolled medical conditions that may pose a safety risk or interfere with participation, as determined by the investigator.
  • Active urinary tract infection at the time of screening (eligible for reconsideration after treatment if appropriate).
  • Current use of treatments for urinary incontinence that cannot be safely maintained at a stable dose throughout the study period.
  • Significant neurological or urological conditions that severely affect bladder function, unless stable and deemed appropriate by the investigator.
  • Participation in another interventional clinical trial that could influence study outcomes or participant safety.
  • Any other condition that, in the opinion of the investigator, would compromise participant safety, study adherence, or data integrity.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: Kontrollgruppe
Placebo
Annen: Placebokontroll
Placebokontroll
Eksperimentell: Chinese Herbal Intervention
Standardized Chinese herbal medicine
Annen: Chinese Herbal Medicine (CHM) supplement
Chinese Herbal Medicine (CHM) supplement

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF).
Tidsramme: From enrollment to approximately week 4.
Primary outcomes will focus on the frequency and severity of urinary incontinence episodes, measured using validated questionnaires. Min = 0 and Max = 6, with higher scores indicating more frequent/severe urinary incontinence.
From enrollment to approximately week 4.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Urinary Incontinence Quality of Life Questionnaire (I-QOL)
Tidsramme: From enrollment to approximately Week 4.
Secondary outcomes include quality of life, symptom distress, and any adverse events. A mean score for each subscale is calculated (averaging the scores for the items in each subscale) as well as a total score for all 22 items (sum of all subscale scores). The scores are then transformed to a 'Scale score' ranging from 0-100 points for ease of interpretation: Scale score = (sum of the items - lowest possible score)/possible raw score range X 100.
From enrollment to approximately Week 4.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Kwantlen Polytechnic University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juni 2026

Primær fullføring (Antatt)

1. desember 2027

Studiet fullført (Antatt)

1. mai 2028

Datoer for studieregistrering

Først innsendt

2. juni 2026

Først innsendt som oppfylte QC-kriteriene

5. juni 2026

Først lagt ut (Faktiske)

9. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • KPU REB # 2022-22

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Individual participant data (IDP) will not be shared to adhere to the requirements of our Research Ethics Board Approval.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere