Vitamin C Effectiveness in Preventing Urinary Tract Infections After Gynecological Surgeries

Last updated: August 5, 2024
Sponsor: American University of Beirut Medical Center
Overall Status: Active - Recruiting

Phase

2

Condition

Urinary Tract Infections

Treatment

Placebo

Ascorbic Acid 1000 MG

Clinical Study ID

NCT05913180
62/137-H/77-2023-25-2295
  • Ages 18-80
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Nonpregnant women

  • 18 years of age or older

  • Undergoing elective GYN surgery

Exclusion

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

  • Diabetes

  • G6PD

  • Hemochromatosis

  • Renal disorders

Study Design

Total Participants: 180
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
September 19, 2023
Estimated Completion Date:
August 15, 2025

Study 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.

Connect with a study center

  • Moscow State University of Medicine and Dentistry

    Moscow,
    Russian Federation

    Active - Recruiting

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