Effectiveness of Chinese Herbal Medicine for Older Adults With Urinary Incontinence

NCT07637175 | Not Yet Recruiting

• 1 other identifier: KPU REB # 2022-22
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence (UI)

Keywords

Traditional Chinese Medicine; Urinary Incontinence; Herbal Treatment; Stage IV Clinical Trial; Older Adults

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to approximately week 4.

Secondary Outcomes (1)

• Urinary Incontinence Quality of Life Questionnaire (I-QOL)

  From enrollment to approximately Week 4.

Study Arms (2)

Chinese Herbal Intervention

EXPERIMENTAL

Standardized Chinese herbal medicine

Other: Chinese Herbal Medicine (CHM) supplement

Control Group

PLACEBO COMPARATOR

Placebo

Other: Placebo Control

Interventions

Chinese Herbal Medicine (CHM) supplement OTHER

Chinese Herbal Medicine (CHM) supplement

Chinese Herbal Intervention

Placebo Control OTHER

Placebo Control

Control Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kwantlen Polytechnic University: lead

Study Sites (1)

Student Traditional Chinese Medicine Clinic

Richmond, British Columbia, V6X 3X7, Canada

Location

MeSH Terms

Conditions

Urinary Incontinence

Interventions

Rab geranylgeranyltransferase

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

John Yang, Dr.

CONTACT

604-599-2286; john.yang@kpu.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Deparment of Traditional Chinese Medicine

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 9, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)