Clinical trial NCT05015400: Female Urogenital Nutrition- Health Study
Official title: Female Urogenital Nutrition- Health Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bacterial Urinary Tract Infection
Lead sponsor: Arizona State University
Sponsor class: OTHER
First posted: 2021-08-20
Enrollment: 13
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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?

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

Primary outcomes:
measure: Uropathogenic Bacterial Activity
timeFrame: Change from Baseline Uropathogenic Bacterial Activity at 1 month
Secondary outcomes:
measure: Hydration Status
timeFrame: Change from Baseline Hydration Status at 1 month
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona State University
state: Arizona
Study officials:
affiliation: Arizona State University
name: Kaila A Vento, PhD(c)
role: PRINCIPAL_INVESTIGATOR
References: