Urinary Incontinence
Conditions
Brief summary
Brief Summary The goal of this clinical trial is to evaluate the effectiveness of ERr 731® (a standardized extract from the roots of Rheum rhaponticum L., also known as rhubarb) in treating urinary incontinence in Chinese women aged 20 to 65 years. Urinary incontinence is a common condition that affects women's quality of life, and current treatment options often have side effects or limited tolerability. ERr 731® has been safely used as a dietary supplement in Europe and the United States and may offer a new approach to improving bladder control. The main question it aims to answer is: Does taking ERr 731® daily for 12 weeks reduce the severity of urinary incontinence, as measured by the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF) score? Secondary questions include: Does ERr 731® reduce the frequency and severity of urinary incontinence episodes, improve quality of life, and reduce daytime and nighttime leakage? This is a single-arm study, meaning all participants will receive the same intervention. There is no comparison group receiving a placebo or alternative treatment. Participants will: Take one tablet of ERr 731® (4 mg) orally every day for 12 weeks Complete self-assessment questionnaires (ICIQ-SF) to report their incontinence symptoms at multiple time points Keep an electronic bladder diary to record the frequency of incontinence episodes Undergo a 1-hour pad test to measure urine leakage at selected visits Attend a total of 6 study visits over 15 weeks: screening/baseline (Visit 1), treatment initiation (Visit 2, Day 1), and follow-up visits at Week 4 (Visit 3), Week 8 (Visit 4), Week 12 (Visit 5, end of treatment), and Week 15 (Visit 6, post-treatment follow-up) Complete safety assessments, including monitoring for any adverse events The study will enroll approximately 112 participants across multiple centers in China. All participants will receive the study product free of charge and will receive compensation for transportation costs. Participants who become pregnant or have certain medical conditions (e.g., endometriosis, severe organ diseases) will not be eligible to participate.
Interventions
DRUGRhubarb Root Extract (ERr 731)
ERr 731® is a purified and standardized dry extract from the roots of Rheum rhaponticum L. (rhubarb), available as 4 mg oral tablets containing 2.16 mg of rhaponticin per tablet. Participants receive one tablet daily (4 mg/day) for 12 consecutive weeks. It is a dietary supplement already marketed in Europe and the United States, with no reported serious adverse events in prior studies lasting up to 2 years. The intervention is administered orally, and participants are followed for an additional 3 weeks post-treatment to assess durability of effect.
Sponsors
Wuxi Maternity and Child Health Care Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Meet the diagnostic criteria for urinary incontinence according to the "Guidelines for the Diagnosis and Treatment of Urinary Incontinence," with at least one episode of urinary incontinence per week in the past month; * Female, aged ≥20 years and ≤65 years; * Premenopausal participants must have a history of vaginal delivery; postmenopausal participants have no restriction on delivery mode (cesarean section is also eligible); * Have normal communication skills; * No history of urogenital system diseases prior to delivery; * Willing to participate in the study and sign the informed consent form.
Exclusion criteria
* Confirmed or clinically suspected malignant tumors or severe diseases of the heart, brain, liver, kidneys, or other vital organs; * Plan to become pregnant within 6 months; pregnant or breastfeeding women; * Patients with endometriosis; * Use of medications affecting bladder function within 2 weeks, or concomitant pathological bladder diseases; * History of pelvic floor dysfunction surgery or stress urinary incontinence surgery; * Allergy to the study product; * Urogenital system infection, chronic cough, or history of constipation; * Neuromuscular diseases caused by other factors; * Disease severity requiring surgical intervention; * Dementia or psychiatric disorders; * Refusal to sign the informed consent form; * Currently participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF) is used to assess the change in urinary incontinence severity from baseline to Week 12 | Baseline (Visit 1) to Week 12 (Visit 5, end of treatment) | The ICIQ-SF total score ranges from 0 to 21, with higher scores indicating more severe urinary incontinence symptoms and a decrease in score denoting improvement. The questionnaire comprises the following four dimensions:Frequency of urinary incontinence (0-5 points)、Amount of leakage (0-6 points)、Impact of leakage on daily life (0-10 points)、Self-reported type of urinary incontinence (not included in the total score; used for descriptive classification).Primary analysis measure: the difference between the baseline ICIQ-SF total score and the Week 12 ICIQ-SF total score (baseline value minus post-treatment value), with a positive value indicating symptom improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Urinary Incontinence Frequency from Baseline to Week 12 | Baseline (Visit 1) to Week 12 (Visits 3, 4, 5) | Urinary incontinence frequency is assessed using the electronic voiding diary (episodes per day) and Item 1 of the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF) (frequency score ranges from 0 to 5, with higher scores indicating more frequent incontinence). A decrease from baseline represents improvement. |
| Mean Change in Urinary Incontinence Severity from Baseline to Week 12 | Baseline (Visit 1) to Week 12 (Visit 5) | Urinary incontinence severity is assessed using the 1-hour pad test (amount of leakage in grams) and Item 2 of the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF) (leakage amount score ranges from 0 to 6, with higher scores indicating more severe leakage). A decrease from baseline denotes improvement. |
| Percentage Reduction in Daytime and Nighttime Incontinence Frequency from Baseline to Week 12 | Baseline (Visit 1) to Week 12 (Visits 3, 4, 5) | Daytime and nighttime urinary incontinence frequency is assessed using the electronic voiding diary (number of daytime episodes and number of nighttime episodes). The outcome is measured as the percentage decrease from baseline. A higher percentage reduction indicates greater improvement. |
| Change in Urinary Incontinence-Specific Quality of Life from Baseline to Week 12 | Baseline (Visit 1) to Week 12 (Visit 5) | Incontinence-specific quality of life is assessed using Item 3 of the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF) , which evaluates the impact of urine leakage on daily life (score ranges from 0 to 10, with higher scores indicating a greater negative impact on quality of life). A decrease from baseline represents improvement. |
Outcome results
None listed