Vitamin C Effectiveness in Preventing Urinary Tract Infections After Gynecological Surgeries

Phase 2

Recruiting

• Conditions: Catheter-Associated Urinary Tract Infection
• Interventions: Drug: Placebo; Drug: Ascorbic Acid 1000 MG

• Registration Number: NCT05913180
• Lead Sponsor: American University of Beirut Medical Center

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 Timeline

• Study First Submitted: 2023-06-10
• Study First Submitted QC: 2023-06-21
• Study First Posted: 2023-06-22
• Study Start: 2023-09-19
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-05
• Last Update Posted: 2024-08-06
• Primary Completion: 2025-08-15
• Study Completion: 2025-08-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 180

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo daily starting the day of elective gynecological surgery for 10 days
Vitamin C	Ascorbic Acid 1000 MG	1000mg Ascorbic acid daily starting the day of elective gynecological surgery for 10 days

Primary Outcome Measures

Name	Time	Method
Incidence of UTI	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 Outcome Measures

Name	Time	Method
Asymptomatic UTI	30 days	The proportion of participants with a positive urine culture, while asymptomatic (asymptomatic bacteriuria) at the end of the study period

Trial Locations

Locations (1)

Moscow State University of Medicine and Dentistry; 🇷🇺 Moscow, Russian Federation