Urinary IncontinenceNCT07783841

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

A study testing Rhubarb Root Extract (ERr 731) in people with Urinary Incontinence, run by Wuxi Maternity and Child Health Care Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

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Trial summary

Who is it for?: Ages 20 to 65 years, women only
Conditions the study is for: Urinary Incontinence
What is being tested?: Rhubarb Root Extract (ERr 731)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 112 participants
Where: No sites listed yet
Study dates: 15 Aug 2026to 20 Jan 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 65 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

Show all 12Show fewer

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.

About this study

Official title: 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.

Conditions: Urinary Incontinence
Being tested: Rhubarb Root Extract (ERr 731)
Medical subject headings: Urinary Incontinence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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 groups in NCT07783841
Study group	Role	What they receive
ERr 731® Intervention Group	Experimental	Not described Receives: Drug: Rhubarb Root Extract (ERr 731)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline (Visit 1) to Week 12 (Visit 5, end of treatment)

Secondary outcomes (4)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Visit 1) to Week 12 (Visit 5)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Aug 202620 Jan 2027

First posted25 Aug 2026
Study start15 Aug 2026 (estimated)
Primary completion15 Jan 2027 (estimated)
Study completion20 Jan 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 112 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07783841
Sponsor's protocol ID: YLSL2025-098-02
Status last verified: Aug 2026
First submitted: 13 Aug 2026
Last updated: 25 Aug 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Urinary Incontinence trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT07783841
Acronym / sponsor ID: YLSL2025-098-02
Conditions: Urinary Incontinence
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 112 participants (estimated)
Lead sponsor: Wuxi Maternity and Child Health Care HospitalUniversity, hospital or other
Study start: 15 Aug 2026 (estimated)
Primary completion: 15 Jan 2027 (estimated)
Study completion: 20 Jan 2027 (estimated)
First posted: 25 Aug 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The main question it aims to answer is:

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

Complete safety assessments, including monitoring for any adverse events

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
ERr 731® Intervention Group	Experimental	Drug: Rhubarb Root Extract (ERr 731)

Who may qualify

Ages: 20 to 65 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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;

Key exclusion criteria (12 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Drug	ERr 731® Intervention Group

Primary outcome

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)
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.

4 secondary outcomes

Mean Change in Urinary Incontinence Frequency from Baseline to Week 12
Time frame: Baseline (Visit 1) to Week 12 (Visits 3, 4, 5)
Mean Change in Urinary Incontinence Severity from Baseline to Week 12
Time frame: Baseline (Visit 1) to Week 12 (Visit 5)
Percentage Reduction in Daytime and Nighttime Incontinence Frequency from Baseline to Week 12
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
Time frame: Baseline (Visit 1) to Week 12 (Visit 5)

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A study testing Rhubarb Root Extract (ERr 731) in people with Urinary Incontinence, run by Wuxi Maternity and Child Health Care Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07783841.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.