An interventional study of Plain Water in Bacterial Urinary Tract Infection, sponsored by Arizona State University. Completed at 1 site in United States. Open to female participants aged 18 Years to 34 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-06.
Sponsored by Arizona State University · Not applicable, Interventional, and Prevention
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.
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?
753 studies on the registry are indexed under Urinary Tract Infections; 128 are open to participants now.
This study's enrollment of 13 is below the median of 130 across 524 interventional studies indexed under Urinary Tract Infections.
Browse Urinary Tract Infections studies →Arizona State University is the lead sponsor of 234 studies on the registry; 41 are open to participants now.
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Exclusion Criteria:
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
The fluid habitual non-intervention arm will a) maintain normal fluid intake volume and beverage choices and a) urination frequency.
To increase water fluid intake, an additional 1.89 L, during phase 1 of the menstrual cycle (days 1-5).
Uropathogenic Bacterial Activity
Number of bacterial colonies and uropathogens found
Time frame: Change from Baseline Uropathogenic Bacterial Activity at 1 month
Hydration Status
Urine concentration via urine specific gravity
Time frame: Change from Baseline Hydration Status at 1 month
Plan to share: Yes — All IPD that underlie results in a publication
Supporting information: Study protocol
No publications or documents are linked to this record.
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Arizona State University