Urinary Incontinence (UI)NCT07637175
Effectiveness of Chinese Herbal Medicine for Older Adults With Urinary Incontinence
A study testing Chinese Herbal Medicine (CHM) supplement in people with Urinary Incontinence (UI), run by Kwantlen Polytechnic University at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Urinary Incontinence (UI)
- What is being tested?
- Chinese Herbal Medicine (CHM) supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2026to May 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Student Traditional Chinese Medicine Clinic
Richmond, British Columbia, V6X 3X7
About this study
Official title: 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.
Read more
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.
- Conditions
- Urinary Incontinence (UI)
- Being tested
- Chinese Herbal Medicine (CHM) supplement, Placebo Control
- Keywords
- Traditional Chinese Medicine, Urinary Incontinence, Herbal Treatment, Stage IV Clinical Trial, Older Adults
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese Herbal Medicine (CHM) supplementOther
Chinese Herbal Medicine (CHM) supplement
Placebo ControlOther
Placebo Control
| Study group | Role | What they receive |
|---|---|---|
| Chinese Herbal Intervention | Experimental | Standardized Chinese herbal medicine Receives: Other: Chinese Herbal Medicine (CHM) supplement |
| Control Group | Placebo comparator | Placebo Receives: Other: Placebo Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF).
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.
Measured: From enrollment to approximately week 4.
Secondary outcomes (1)
Urinary Incontinence Quality of Life Questionnaire (I-QOL)
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.
Measured: From enrollment to approximately Week 4.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Incontinence (UI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kwantlen Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Yang, Kwantlen Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07637175
- Sponsor's protocol ID
- KPU REB # 2022-22
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IDP) will not be shared to adhere to the requirements of our Research Ethics Board Approval.