Vitamin C Effectiveness in Preventing Urinary Tract Infections After Gynecological Surgeries

June 21, 2023 updated by: Tony Bazi, American University of Beirut Medical Center

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

180

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Vitamin C
1000mg Ascorbic acid daily starting the day of elective gynecological surgery for 10 days
Drug: Ascorbic Acid 1000 MG
1000mg Ascorbic acid orally daily started on the day of elective gynecological surgery for 10 days
Other Names:
  • Vitamin C
Placebo Comparator: Placebo
Placebo daily starting the day of elective gynecological surgery for 10 days
Drug: Placebo
Placebo tablet daily starting day of elective gynecological surgery for 10 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

American University of Beirut Medical Center

Collaborators

Moscow State University of Medicine and Dentistry

Investigators

  • Principal Investigator: Tony Bazi, M.D., American University of Beirut Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 15, 2023

Primary Completion (Estimated)

August 15, 2025

Study Completion (Estimated)

August 15, 2025

Study Registration Dates

First Submitted

June 10, 2023

First Submitted That Met QC Criteria

June 21, 2023

First Posted (Actual)

June 22, 2023

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 21, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 62/137-H/77-2023-25-2295

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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