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Not yet recruiting NCT07637175

Effectiveness of Chinese Herbal Medicine for Older Adults With Urinary Incontinence

No phase Interventional Urinary Incontinence (UI)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Chinese Herbal Medicine (CHM) supplement, Placebo Control.
Who it may be relevant to
Registry conditions: Urinary Incontinence (UI). Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Other Chinese Herbal Medicine (CHM) supplement
    Chinese Herbal Medicine (CHM) supplement
  • Other Placebo Control
    Placebo Control

Primary outcome measures

  • International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF). [Time frame: From enrollment to approximately week 4.]
Secondary outcome measures (1)
  • Urinary Incontinence Quality of Life Questionnaire (I-QOL) [Time frame: From enrollment to approximately Week 4.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Student Traditional Chinese Medicine Clinic — Richmond

Identifiers

NCT: NCT07637175 · KPU REB # 2022-22

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗