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

Sponsor
Wuxi Maternity and Child Health Care Hospital
Study ID
NCT07783841
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Urinary Incontinence

Eligibility Criteria

Sex
FEMALE
Age
20 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Rhubarb Root Extract (ERr 731) — DRUG
    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.

Study Details

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.

Key Dates

First listed
Aug 25, 2026
Start date
Aug 15, 2026
Status verified
Aug 2026
Primary completion
Jan 15, 2027
Completion
Jan 20, 2027

Study Design

Enrollment
112 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ERr 731® Intervention Group

Primary Outcome Measure

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 [ Time Frame: Baseline (Visit 1) to Week 12 (Visit 5, end of treatment) ]

Related Studies