Urinary Incontinence (UI)
Conditions
Keywords
Traditional Chinese Medicine, Urinary Incontinence, Herbal Treatment, Stage IV Clinical Trial, Older Adults
Brief 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.
Interventions
Chinese Herbal Medicine (CHM) supplement
OTHERPlacebo Control
Placebo Control
Sponsors
Kwantlen Polytechnic University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF). | 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
| Measure | Time frame | Description |
|---|---|---|
| Urinary Incontinence Quality of Life Questionnaire (I-QOL) | 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. |
Countries
Canada
Contacts
CONTACTJohn Yang, Dr.
Outcome results
None listed