Vitamin C Effectiveness in Preventing Urinary Tract Infections After Gynecological Surgeries

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Catheter-Associated Urinary Tract Infection

Intervention / Treatment
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* Drug: Ascorbic Acid 1000 MG
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vitamin C<br>1000mg Ascorbic acid daily starting the day of elective gynecological surgery for 10 days | Drug: Ascorbic Acid 1000 MG<br>* 1000mg Ascorbic acid orally daily started on the day of elective gynecological surgery for 10 days<br>* Other names: Vitamin C;|
| Placebo Comparator: Placebo<br>Placebo daily starting the day of elective gynecological surgery for 10 days | Drug: Placebo<br>* Placebo tablet daily starting day of elective gynecological surgery for 10 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of UTI | 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 | The proportion of participants with a positive urine culture, while asymptomatic (asymptomatic bacteriuria) at the end of the study period | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ascorbic acid, Vitamin C, Elective Gynecologic surgeries, CAUTI