An interventional study of Rhubarb Root Extract (ERr 731) in Urinary Incontinence, sponsored by Wuxi Maternity and Child Health Care Hospital. Not yet recruiting. Open to female participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by Wuxi Maternity and Child Health Care Hospital · Not applicable, Interventional, and Treatment
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.
983 studies on the registry are indexed under Urinary Incontinence; 180 are open to participants now.
This study's planned enrollment of 112 is above the median of 66 across 739 interventional studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →This is the only study on the registry with Wuxi Maternity and Child Health Care Hospital as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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
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.
Time frame: Baseline (Visit 1) to Week 12 (Visit 5, end of treatment)
Mean Change in Urinary Incontinence Frequency from Baseline to Week 12
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.
Time frame: Baseline (Visit 1) to Week 12 (Visits 3, 4, 5)
Mean Change in Urinary Incontinence Severity from Baseline to Week 12
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.
Time frame: Baseline (Visit 1) to Week 12 (Visit 5)
Percentage Reduction in Daytime and Nighttime Incontinence Frequency from Baseline to Week 12
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.
Time frame: Baseline (Visit 1) to Week 12 (Visits 3, 4, 5)
Change in Urinary Incontinence-Specific Quality of Life from Baseline to Week 12
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.
Time frame: Baseline (Visit 1) to Week 12 (Visit 5)
No study locations are listed for this record.
Start is estimated for Aug 2026; primary completion for Jan 2027, 5 months later.
Of 301 non-industry interventional studies with no phase under Urinary Incontinence, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 37. This study's planned 5 months is below that.
Counting every sponsor, half of 364 studies reached it within 15 months; a quarter within 7 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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