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Clinical Trials/NCT05913180
NCT05913180RecruitingPhase 2

Vitamin C for the Prevention of Catheter-associated Urinary Tract Infections in Women Who Undergo Elective Gynecological Surgeries: a Randomized Double-blinded Controlled Trial

American University of Beirut Medical Center1 site in 1 country180 target enrollmentStarted: September 19, 2023Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Recruiting
Enrollment
180
Locations
1
Primary Endpoint
Incidence of UTI

Study Overview

Brief Summary

Double-blind placebo-controlled randomized trial aiming to assess the role of Vitamin C supplementation in the prevention of catheter-associated urinary tract infections in women undergoing elective gynecological surgeries.

Detailed Description

Women undergoing Elective GYN surgery are a particularly high-risk group for UTIs, because these operations involve surgery adjacent to the bladder and delayed bladder emptying is common. It has been estimated that the 'risk of Urinary tract infections among women undergoing elective Gynecologic GYN surgery is between 10-64%, following catheter removal. Catheterization, in itself, poses a significant risk for UTIs because insertion and removal introduce bacteria and cause trauma, both of which may increase the risk of UTIs. The incidence of UTI for women in the general population is estimated to be 3-4% per year vs 5% per day of catheterization. For this reason, multiple interventions have been studied for the prevention of UTIs. Ascorbic acid (vitamin C) is often suggested as a supplement that can prevent recurrent UTIs by acidification of the urine. Strong clinical evidence to support this claim in healthy adult women is lacking. Because of the lack of literature regarding the use of Vitamin C as a prophylactic agent for the prevention of UTIs, the investigators wish to conduct this study to assess the potential therapeutic efficacy of Ascorbic acid in preventing UTIs after elective GYN surgery.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Participant, Care Provider)

Masking Description

Double blinded

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Nonpregnant women
  • 18 years of age or older
  • Undergoing elective GYN surgery

Exclusion Criteria

  • Pregnant women
  • Already taking Vitamin C supplementation
  • Nephrolithiasis
  • Congenital anomaly or neurogenic bladder
  • Allergy to ascorbic acid
  • On therapeutic anticoagulant medicine during the 6 weeks after surgery
  • Gynecological surgery involving fistula repair or a vaginal mesh removal
  • Positive Urinalysis in the pre-admission unit
  • Recurrent UTIs
  • Hemochromatosis
  • Renal disorders

Arms & Interventions

Vitamin C

Active Comparator

1000mg Ascorbic acid daily starting the day of elective gynecological surgery for 10 days

Intervention: Ascorbic Acid 1000 MG (Drug)

Placebo

Placebo Comparator

Placebo daily starting the day of elective gynecological surgery for 10 days

Intervention: Placebo (Drug)

Outcomes

Primary Outcomes

Incidence of UTI

Time Frame: 30 days

The Primary endpoint is the proportion of participants who experience a clinically diagnosed and treated UTI as evidenced by a positive urine culture.

Secondary Outcomes

  • Asymptomatic UTI(30 days)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Tony Bazi

Associate Professor of Clinical Obstetrics and Gynecology

American University of Beirut Medical Center

Study Sites (1)

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