Female Urogenital Nutrition- Health Study (FUN-Health)
Primary Purpose
Bacterial Urinary Tract Infection
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Plain Water
Sponsored by
About this trial
This is an interventional prevention trial for Bacterial Urinary Tract Infection
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
Sites / Locations
- Arizona State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Fluid Increase
Fluid Habitual
Arm Description
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.
The fluid habitual non-intervention arm will a) maintain normal fluid intake volume and beverage choices and a) urination frequency.
Outcomes
Primary Outcome Measures
Uropathogenic Bacterial Activity
Number of bacterial colonies and uropathogens found
Secondary Outcome Measures
Hydration Status
Urine concentration via urine specific gravity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05015400
Brief Title
Female Urogenital Nutrition- Health Study
Acronym
FUN-Health
Official Title
Female Urogenital Nutrition- Health Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
September 5, 2021 (Actual)
Primary Completion Date
December 15, 2021 (Actual)
Study Completion Date
January 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Arizona State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Urinary Tract Infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fluid Increase
Arm Type
Experimental
Arm Description
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.
Arm Title
Fluid Habitual
Arm Type
No Intervention
Arm Description
The fluid habitual non-intervention arm will a) maintain normal fluid intake volume and beverage choices and a) urination frequency.
Intervention Type
Other
Intervention Name(s)
Plain Water
Intervention Description
To increase water fluid intake, an additional 1.89 L, during phase 1 of the menstrual cycle (days 1-5).
Primary Outcome Measure Information:
Title
Uropathogenic Bacterial Activity
Description
Number of bacterial colonies and uropathogens found
Time Frame
Change from Baseline Uropathogenic Bacterial Activity at 1 month
Secondary Outcome Measure Information:
Title
Hydration Status
Description
Urine concentration via urine specific gravity
Time Frame
Change from Baseline Hydration Status at 1 month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
34 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kaila A Vento, PhD(c)
Organizational Affiliation
Arizona State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona State University
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All IPD that underlie results in a publication
IPD Sharing Time Frame
Starting 6 months after publication.
Learn more about this trial
Female Urogenital Nutrition- Health Study
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