Female Urogenital Nutrition- Health Study

NCT ID: NCT05015400

Last Updated: 2022-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-05
• Study Completion Date: 2022-01-01

Brief Summary

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.

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?

Conditions

Bacterial Urinary Tract Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Plain Water

Intervention Type: OTHER

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

Fluid Habitual

The fluid habitual non-intervention arm will a) maintain normal fluid intake volume and beverage choices and a) urination frequency.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Plain Water

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 34 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Arizona State University

OTHER

Sponsor Role: lead

Responsible Party

Kaila Vento

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kaila A Vento, PhD(c)

Role: PRINCIPAL_INVESTIGATOR

Arizona State University

Locations

Arizona State University

Phoenix, Arizona, United States

Countries

United States

Other Identifiers

STUDY00014289

Identifier Type: -

Identifier Source: org_study_id