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A Single-Arm Exploratory Study of NatureU Pelvic Health Pumpkin Seed in Women With Urinary Frequency and Leakage Symptoms
Sponsor: OmniSolutions Laboratory Holdings Limited
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.
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
Key Details
Gender
FEMALE
Age Range
35 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
19
Start Date
2024-07-15
Completion Date
2024-07-22
Last Updated
2026-05-07
Healthy Volunteers
No
Conditions
Interventions
NatureU Pelvic Health Pumpkin Seed
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.
Locations (1)
Dao County People's Hospital
Yongzhou, Hunan, China