A Single-Arm Exploratory Study of NatureU Pelvic Health Pumpkin Seed in Women With Urinary Frequency and Leakage Symptoms

NCT07571616 | Completed

• 1 other identifier: 2024070001
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Urinary Incontinence; Urinary Frequency

Keywords

NatureU Pelvic Health Pumpkin Seed; pumpkin seed extract; soybean extract; pelvic health; urinary leakage; Women Toileting Behavior Scale

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and Day 8 after 7 days of product intake

Secondary Outcomes (1)

• Change From Baseline in Incontinence Quality of Life Total Score

  Baseline and Day 8 after 7 days of product intake

Other Outcomes (2)

• Patient Global Impression of Improvement

  Day 8 after 7 days of product intake

• Safety and Tolerability During Product Intake

  Baseline through Day 8

Study Arms (1)

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.

Dietary Supplement: NatureU Pelvic Health Pumpkin Seed

Interventions

NatureU Pelvic Health Pumpkin Seed DIETARY_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.

NatureU Pelvic Health Pumpkin Seed

Eligibility Criteria

• Age: 35 Years - 55 Years
• Gender Eligibility Details: The study population was limited to adult women because the study evaluated female urinary frequency and urinary leakage symptoms.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Participants who signed informed consent before the study and understood the study content, procedures, and possible adverse reactions.
• Adult women aged 35 to 55 years, inclusive, with urinary frequency and urinary leakage symptoms.
• Body weight at least 50 kg and body mass index between 18.5 and 23.9 kg/m2, inclusive.
• Participants able to maintain normal healthy routines and abstain from alcohol during the study period.

You may not qualify if:

• Pregnant or breastfeeding women, or women with recent pregnancy plans.
• Known allergy or hypersensitivity to product ingredients, including pumpkin or soybean, or a 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.
• 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 or a 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.

Sponsors & Collaborators

• OmniSolutions Laboratory Holdings Limited: lead

Study Sites (1)

Dao County People's Hospital

Yongzhou, Hunan, 425300, China

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Luke Law, Dr

  OmniSolutions Laboratory Holdings Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The study was open-label with no masking.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants received NatureU Pelvic Health Pumpkin Seed for 7 consecutive days in a single-arm self-controlled exploratory design.

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 6, 2026
• Study Start: July 15, 2024
• Primary Completion: July 22, 2024
• Study Completion: July 22, 2024
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)