Female Urogenital Nutrition- Health Study (FUN-Health)

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.

Study Overview

• Status: Completed
• Conditions: Bacterial Urinary Tract Infection
• Intervention / Treatment: Other: Plain Water

Detailed Description

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?

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85004
      • Arizona State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 34 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Fluid Increase; The increased fluid intervention arm will begin on day 2 after the onset of bleeding (day 1) of their phase 1 menses through day 5. For the increased fluid intake intervention, participants will a) consume an additional 64 oz (1.89 L) of plain water only on top of habitual fluid intake and b) aim to at least urinate 5 times per day.	Other: Plain Water; To increase water fluid intake, an additional 1.89 L, during phase 1 of the menstrual cycle (days 1-5).
NO_INTERVENTION: Fluid Habitual; The fluid habitual non-intervention arm will a) maintain normal fluid intake volume and beverage choices and a) urination frequency.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uropathogenic Bacterial Activity	Number of bacterial colonies and uropathogens found	Change from Baseline Uropathogenic Bacterial Activity at 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hydration Status	Urine concentration via urine specific gravity	Change from Baseline Hydration Status at 1 month

Collaborators and Investigators

• Sponsor: Arizona State University
• Investigators: Principal Investigator: Kaila A Vento, PhD(c), Arizona State University

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 5, 2021
• Primary Completion (ACTUAL): December 15, 2021
• Study Completion (ACTUAL): January 1, 2022

Study Registration Dates

• First Submitted: August 9, 2021
• First Submitted That Met QC Criteria: August 16, 2021
• First Posted (ACTUAL): August 20, 2021

Study Record Updates

• Last Update Posted (ACTUAL): May 6, 2022
• Last Update Submitted That Met QC Criteria: May 2, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Urologic Diseases; Urinary Tract Infections
• Other Study ID Numbers: STUDY00014289

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD that underlie results in a publication
• IPD Sharing Time Frame: Starting 6 months after publication.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No