Female Urogenital Nutrition- Health Study | NCT05015400

Studies
Female Urogenital Nutrition- Health Study

NCT05015400

Sponsor

Arizona State University

Status

Completed

Last Update Posted

May 6, 2022Actual

Enrollment

13Actual

Phase

Not Applicable

Conditions

Bacterial Urinary Tract Infection

Interventions

Plain Water

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 5, 2021Actual

Primary Completion Date

Dec 15, 2021Actual

Completion Date

Jan 1, 2022Actual

First Submitted Date

Aug 9, 2021

First Submission Date that Met QC Criteria

Aug 16, 2021

First Posted Date

Aug 20, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 2, 2022

Last Update Posted Date

May 6, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kaila Vento, Principal Investigator, Arizona State UniversityPrincipal Investigator

Lead Sponsor

Arizona State UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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?

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

13Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fluid Increase	Experimental	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
Fluid Habitual	No Intervention	The fluid habitual non-intervention arm will a) maintain normal fluid intake volume and beverage choices and a) urination frequency.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Plain Water	Other	To increase water fluid intake, an additional 1.89 L, during phase 1 of the menstrual cycle (days 1-5).	Fluid Increase

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

34 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kaila A Vento, PhD(c)	Arizona State University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Arizona State University		Phoenix	Arizona	85004	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

All IPD that underlie results in a publication

Types

Study Protocol

Time Frame

Starting 6 months after publication.

Access Criteria

Not provided

URL

Not provided