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NCT Number: NCT05913180

Vitamin C Effectiveness in Preventing Urinary Tract Infections After Gynecological Surgeries

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.

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Key information

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Moscow State University of Medicine and Dentistry

Moscow, Russia

Location status: Recruiting

Location contact

George Kasyan

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Diabetes
  • G6PD
  • Hemochromatosis
  • Renal disorders

Treatment and study plan

Ascorbic Acid 1000 MG

Drug

1000mg Ascorbic acid orally daily started on the day of elective gynecological surgery for 10 days

Other names: Vitamin C

Placebo

Drug

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

Primary outcomes

  1. 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

  1. Asymptomatic UTI

    Time frame: 30 days

    The proportion of participants with a positive urine culture, while asymptomatic (asymptomatic bacteriuria) at the end of the study period

Study contacts

Contact information is provided by the study sponsor or research team.

George kasyan, M.D.

CONTACT

[email protected]

Tony Bazi, M.D.

CONTACT

[email protected]

9611350000

Sponsors and collaborators

Lead sponsor

American University of Beirut Medical Center

Other

Collaborators

  • Moscow State University of Medicine and Dentistry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 22, 2023
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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