Vitamin C Effectiveness in Preventing Urinary Tract Infections After Gynecological Surgeries

American University of Beirut Medical Center

Status and phase: Enrolling; Phase 2

Conditions: Catheter-Associated Urinary Tract Infection

Treatments: Drug: Ascorbic Acid 1000 MG; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05913180

62/137-H/77-2023-25-2295

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 2 patient groups, including a placebo group

Vitamin C

Active Comparator group

Description:

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

Treatment:

Drug: Ascorbic Acid 1000 MG

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo