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

NCT07783841 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2026-08-25

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Rhubarb 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 & Collaborators

  • Wuxi Maternity and Child Health Care Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-15
Primary Completion
2027-01-15
Completion
2027-01-20

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07783841 on ClinicalTrials.gov