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Completed

NCT Number: NCT05015400

Female Urogenital Nutrition- Health Study

The purpose of this study is to assess nutrition and urinary tract bacterial activity during menstruation of approximately 15 female university Reserve Officer Training Corps (ROTC) cadets and Phoenix area police officers, firefighters, and military veterans.

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Key information

Age range

18 year–34 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Arizona State University

Phoenix, Arizona, 85004, United States

About this study

Urinary tract infections (UTIs) disrupt tactical service women's obligations and health, which increases sexual transmitted infections (STIs), HPV, and cervical cancer risk if left untreated. Females are more susceptible to UTIs due to their unique anatomical features and hormone fluctuations affecting vaginal flora. During phase 1 of the menstrual cycle (i.e., onset of bleeding, menstrual cycle days 1-5), estrogen levels significantly decrease and inhibit the growth of lactobacilli (good bacteria), which is essential in warding off bad bacteria and infections, particularly UTIs. The uropathogenic bacterial growth in phase 1 could be heightened in phase 2 of the menstrual cycle (i.e., leading to ovulation), as increases in estrogen favors bacteria adhesion and arginine vasopressin (AVP) release that stimulates fluid retention, leading to less volume flow in the urinary tract. To reduce UTI onset, it is recommended to frequently urinate with sufficient urine void volume to facilitate washing out harmful bacteria from the urethra and bladder. While menstruating, increased fluid consumption to support urination frequency and void volume may be critical, as the urinary tract is more predisposed to infections, and the effects of estrogen on bacterial adhesion and AVP release in phase 2 could continue uropathogenic growth.

Question(s) 1: Are premenopausal tactical service women's current hydration status and behaviors (i.e., fluid intake and urination) sufficient? How many premenopausal tactical service women have a UTI history?

Question 2: Will increasing daily water intake of identified underhydrated tactical service women reduce uropathogenic bacterial activity during the first part (i.e., onset of bleeding through day 5) of the menstrual cycle?

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female
  • 18-34 years of age or older (premenopausal)
  • Have a 21-35-day menstrual cycle
  • No changes in hormonal contraceptives within the last three months
  • No current UTI symptoms
  • Sexual activity and inactivity

Exclusion criteria

  • Males
  • Under 18 years of age or over 34 years of age
  • Pregnant or nursing
  • Menstrual irregularities effecting having a menstrual cycle to be between 21-35 days
  • Progesterone-only contraceptive use (combined estrogen-progesterone and non-hormonal IUDs are okay)
  • Currently taking antibiotics
  • On hormone replacement therapy
  • Currently experiencing symptomatic vulvovaginitis
  • Diagnosed with recurrent UTI
  • Not volunteering to participate

Treatment and study plan

Plain Water

Other

To increase water fluid intake, an additional 1.89 L, during phase 1 of the menstrual cycle (days 1-5).

Primary outcomes

  1. Uropathogenic Bacterial Activity

    Time frame: Change from Baseline Uropathogenic Bacterial Activity at 1 month

    Number of bacterial colonies and uropathogens found

Secondary outcomes

  1. Hydration Status

    Time frame: Change from Baseline Hydration Status at 1 month

    Urine concentration via urine specific gravity

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Registry information

Acronym: FUN-Health

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Aug 20, 2021
Registry last updated
May 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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