Effectiveness of Chinese Herbal Medicine for Older Adults With Urinary Incontinence (NCT07637175) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effectiveness of Chinese Herbal Medicine for Older Adults With Urinary Incontinence
Canada150 participantsStarted 2026-06-01
Plain-language summary
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.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF).
Timeframe: From enrollment to approximately week 4.