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NCT Number: NCT07637175

Effectiveness of Chinese Herbal Medicine for Older Adults With Urinary Incontinence

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Student Traditional Chinese Medicine Clinic

Richmond, British Columbia, V6X 3X7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Chinese Herbal Medicine (CHM) supplement

Other

Chinese Herbal Medicine (CHM) supplement

Placebo control

Other

Placebo Control

Primary outcomes

  1. International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF).

    Time frame: 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.

Secondary outcomes

  1. Urinary Incontinence Quality of Life Questionnaire (I-QOL)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

John Yang, Dr.

CONTACT

[email protected]

604-599-2286

Sponsors and collaborators

Lead sponsor

Kwantlen Polytechnic University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jun 9, 2026
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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