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

OmniSolutions Laboratory Holdings Limited19 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Eligibility

Sex: FEMALEMin age: 35 YearsMax age: 55 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.

Outcomes

Primary Outcomes

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.

Time frame: Baseline and Day 8 after 7 days of product intake

Secondary Outcomes

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.