Urinary IncontinenceNUPHPSNCT07571616
A Single-Arm Exploratory Study of NatureU Pelvic Health Pumpkin Seed in Women With Urinary Frequency and Leakage Symptoms
A study testing NatureU Pelvic Health Pumpkin Seed in people with Urinary Incontinence and Urinary Frequency, run by OmniSolutions Laboratory Holdings Limited at 1 site in China.
Trial summary
This was a single-center, open-label, single-arm, exploratory human study evaluating NatureU Pelvic Health Pumpkin Seed in adult women with urinary frequency and urinary leakage symptoms. Read more about this study
- Who is it for?
- Ages 35 to 55 years, women only
- Conditions the study is for
- Urinary Incontinence, Urinary Frequency
- What is being tested?
- NatureU Pelvic Health Pumpkin Seed
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2024to 22 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 35 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Signed informed consent before the study and understood the study content, procedures, and possible adverse reactions.
- Adult woman aged 35 to 55 years, inclusive.
- Had urinary frequency and urinary leakage symptoms.
- Body weight at least 50 kg.
- Body mass index between 18.5 and 23.9 kg/m2, inclusive.
- Able to maintain normal healthy routines during the study period.
- Able to abstain from alcohol during the study period.
Who cannot join
- Pregnant or breastfeeding.
- Recent pregnancy plans.
- Known allergy or hypersensitivity to product ingredients, including pumpkin or soybean.
- History of multiple food allergies.
- Diagnosed diabetes or other metabolic disease.
- Clinically significant abnormalities in blood glucose, blood pressure, physical examination, or vital signs as judged by the investigator.
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- Acute or chronic inflammatory disease, including influenza A, within the previous month.
- Participation in any other clinical trial within 1 month before first use of the study product.
- Clinically significant disease within the previous 6 months judged by the investigator to make participation inappropriate.
- Acute illness or concomitant medication use from screening to first use of the study product.
- Surgery within the previous 3 months.
- Blood donation or major blood loss greater than 450 mL within the previous 3 months.
- Difficulty swallowing.
- Gastrointestinal disease history affecting product intake.
- Any disease that increases bleeding risk, such as hemorrhoids, acute gastritis, or gastric or duodenal ulcer.
- Use of prescription or non-prescription medications affecting nutritional supplements or hormone levels.
- Substantial weight change within the previous month.
- Any other factor judged by the investigator to make participation inappropriate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Center, Open-Label, Single-Arm Exploratory Study of NatureU Pelvic Health Pumpkin Seed in Adult Women With Urinary Frequency and Urinary Leakage Symptoms
This was a single-center, open-label, single-arm, exploratory human study evaluating NatureU Pelvic Health Pumpkin Seed in adult women with urinary frequency and urinary leakage symptoms. Twenty-seven participants were recruited, 19 were screened and enrolled, and 19 completed the study and were included in the effectiveness analysis. Participants took the study product for 7 consecutive days, one tablet after lunch and one tablet after dinner, for a total daily intake of two tablets. Outcomes were assessed before product intake and after 7 days of use. The main outcomes included the Women Toileting Behavior Scale (WTBS) and the Incontinence Quality of Life questionnaire (I-QOL). Patient Global Impression of Improvement (PGI-I), waist circumference, fasting blood glucose, blood pressure, and safety observations were also assessed.
Read the detailed description
The study was designed as an exploratory self-controlled human evaluation of an oral functional food product containing pumpkin seed extract and soybean extract. Eligible female participants aged 35 to 55 years with urinary frequency and urinary leakage symptoms received the study product after investigator review of the inclusion and exclusion criteria. Participants received the product at the study center on Day 0 and took the product continuously for 7 days through Day 7. The report tables compare questionnaire scores at Day 0 and Day 8. Enrollment was completed on July 15, 2024, product intake was completed on July 21, 2024, and evaluation information collection was completed on July 22, 2024. The study was open-label, single-center, and exploratory, with no placebo or parallel control group. Within-participant changes from baseline were analyzed using paired t tests. Safety monitoring included adverse reactions and changes in blood pressure, fasting blood glucose, and waist circumference.
- Conditions
- Urinary Incontinence, Urinary Frequency
- Being tested
- NatureU Pelvic Health Pumpkin Seed
- Keywords
- NatureU Pelvic Health Pumpkin Seed, pumpkin seed extract, soybean extract, pelvic health, urinary leakage, Women Toileting Behavior Scale
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NatureU Pelvic Health Pumpkin SeedDietary supplement
NatureU Pelvic Health Pumpkin Seed is an oral functional food product containing pumpkin seed extract, soybean extract, vitamin D3, sorbitol, maltodextrin, microcrystalline cellulose, and magnesium stearate. Participants took one tablet after lunch and one tablet after dinner each day for 7 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| NatureU Pelvic Health Pumpkin Seed | Experimental | Participants received NatureU Pelvic Health Pumpkin Seed, one tablet after lunch and one tablet after dinner each day for 7 consecutive days. Receives: Dietary Supplement: NatureU Pelvic Health Pumpkin Seed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Women Toileting Behavior Scale Total Score
The Women Toileting Behavior Scale was used to assess urinary behavior. The primary endpoint was the within-participant change in WTBS total score from Day 0 to Day 8 after 7 days of product intake.
Measured: Baseline and Day 8 after 7 days of product intake
Secondary outcomes (1)
Change From Baseline in Incontinence Quality of Life Total Score
The Incontinence Quality of Life questionnaire was used to assess participant-reported quality of life related to urinary incontinence. The secondary endpoint was the within-participant change in I-QOL total score from Day 0 to Day 8 after 7 days of product intake.
Measured: Baseline and Day 8 after 7 days of product intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start15 Jul 2024
- Primary completion22 Jul 2024
- Study completion22 Jul 2024
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants received NatureU Pelvic Health Pumpkin Seed for 7 consecutive days in a single-arm self-controlled exploratory design.
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- OmniSolutions Laboratory Holdings Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luke Law, Dr, Study director, OmniSolutions Laboratory Holdings Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07571616
- Sponsor's protocol ID
- 2024070001
- Other IDs
- 2024070001
- Acronym
- NUPHPS
- Status last verified
- May 2026
- First submitted
- 30 Apr 2026
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to privacy protection and ethical considerations.
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Open-Label, Single-Arm Exploratory Study of NatureU Pelvic Health Pumpkin Seed in Adult Women With Urinary Frequency and Urinary Leakage Symptoms
- ClinicalTrials.gov ID
- NCT07571616
- Acronym / sponsor ID
- NUPHPS / 2024070001
- Conditions
- Urinary Incontinence, Urinary Frequency
- Keywords
- NatureU Pelvic Health Pumpkin Seed, pumpkin seed extract, soybean extract, pelvic health, urinary leakage, Women Toileting Behavior Scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- OmniSolutions Laboratory Holdings LimitedIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 22 Jul 2024 (actual)
- Study completion
- 22 Jul 2024 (actual)
- First posted
- 6 May 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.
This was a single-center, open-label, single-arm, exploratory human study evaluating NatureU Pelvic Health Pumpkin Seed in adult women with urinary frequency and urinary leakage symptoms. Twenty-seven participants were recruited, 19 were screened and enrolled, and 19 completed the study and were included in the effectiveness analysis. Participants took the study product for 7 consecutive days, one tablet after lunch and one tablet after dinner, for a total daily intake of two tablets. Outcomes were assessed before product intake and after 7 days of use. The main outcomes included the Women Toileting Behavior Scale (WTBS) and the Incontinence Quality of Life questionnaire (I-QOL). Patient Global Impression of Improvement (PGI-I), waist circumference, fasting blood glucose, blood pressure, and safety observations were also assessed.
Detailed description
The study was designed as an exploratory self-controlled human evaluation of an oral functional food product containing pumpkin seed extract and soybean extract. Eligible female participants aged 35 to 55 years with urinary frequency and urinary leakage symptoms received the study product after investigator review of the inclusion and exclusion criteria. Participants received the product at the study center on Day 0 and took the product continuously for 7 days through Day 7. The report tables compare questionnaire scores at Day 0 and Day 8. Enrollment was completed on July 15, 2024, product intake was completed on July 21, 2024, and evaluation information collection was completed on July 22, 2024. The study was open-label, single-center, and exploratory, with no placebo or parallel control group. Within-participant changes from baseline were analyzed using paired t tests. Safety monitoring included adverse reactions and changes in blood pressure, fasting blood glucose, and waist circumference.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants received NatureU Pelvic Health Pumpkin Seed for 7 consecutive days in a single-arm self-controlled exploratory design.
| Arm | Type | Receives |
|---|---|---|
| NatureU Pelvic Health Pumpkin Seed | Experimental | Dietary Supplement: NatureU Pelvic Health Pumpkin SeedParticipants received NatureU Pelvic Health Pumpkin Seed, one tablet after lunch and one tablet after dinner each day for 7 consecutive days. |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Signed informed consent before the study and understood the study content, procedures, and possible adverse reactions.
- Adult woman aged 35 to 55 years, inclusive.
- Had urinary frequency and urinary leakage symptoms.
- Body weight at least 50 kg.
- Body mass index between 18.5 and 23.9 kg/m2, inclusive.
Key exclusion criteria (18 listed)
- Pregnant or breastfeeding.
- Recent pregnancy plans.
- Known allergy or hypersensitivity to product ingredients, including pumpkin or soybean.
- History of multiple food allergies.
- Diagnosed diabetes or other metabolic disease.
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 |
|---|---|---|
| NatureU Pelvic Health Pumpkin SeedNatureU Pelvic Health Pumpkin Seed is an oral functional food product containing pumpkin seed extract, soybean extract, vitamin D3, sorbitol, maltodextrin, microcrystalline cellulose, and magnesium stearate. Participants took one tablet after lunch and one tablet after dinner each day for 7 consecutive days. | Dietary supplement | NatureU Pelvic Health Pumpkin Seed |
Primary outcome
Change From Baseline in Women Toileting Behavior Scale Total Score
Time frame: Baseline and Day 8 after 7 days of product intake
The Women Toileting Behavior Scale was used to assess urinary behavior. The primary endpoint was the within-participant change in WTBS total score from Day 0 to Day 8 after 7 days of product intake.
1 secondary outcome
Change From Baseline in Incontinence Quality of Life Total Score
Time frame: Baseline and Day 8 after 7 days of product intake
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to privacy protection and ethical considerations.
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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. This study is not recruiting at the moment.
Luke Law, Dr study director
OmniSolutions Laboratory Holdings Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NatureU Pelvic Health Pumpkin Seed in people with Urinary Incontinence and Urinary Frequency, run by OmniSolutions Laboratory Holdings Limited at 1 site in China.
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 7 inclusion and 18 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: finished, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change From Baseline in Women Toileting Behavior Scale Total Score (time frame: Baseline and Day 8 after 7 days of product intake). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 May 2026.