Evaluating ERr 731 in Chinese Women With Urinary Incontinence: A Prospective Open-Label Study

A National, Multicenter, Prospective, Single-Arm, Open-Label Clinical Study to Evaluate the Effect of ERr 731® (Rhubarb Root Extract) in Chinese Female Patients With Urinary Incontinence

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.

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.