Vitamin C for the Prevention of UTI in Women Who Undergo Elective Gynecological Surgeries

Study Overview
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Brief Summary
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This open-label randomized trial aims at assessing the role of Vitamin C pills in the prevention of catheter-associated urinary tract infections in women undergoing elective gynecological surgeries.

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 Study Protocol for a Randomized Double Blinded Controlled Trial.

Conditions
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Catheter-Associated Urinary Tract Infection, Ascorbic Acid

Intervention / Treatment
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* Drug: Ascorbic Acid 1000 mg
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non pregnant women at least 18 years of age visiting the Preadmission unit (PAU) or the OBGYN floor (7N), presenting for elective GYN surgery at the American University of Beirut Medical Center (AUBMC). Exclusion Criteria: Any women with the following: Nephrolithiasis Congenital anomaly or neurogenic bladder Allergy to ascorbic acid Who require therapeutic anticoagulant medicine during the 6 weeks after surgery Surgery did involve a fistula repair or a vaginal mesh removal Positive Urinalysis in the PAU Recurrent UTI's Diabetes G6PD Hemochromatosis Renal disorders Patients already taking Vitamin C supplementation will also be excluded from the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Women on a vitamin C regimen<br>Women who are undergoing elective gynecological surgeries and who are randomized to take 1g of vitamin C for 14 days. | Drug: Ascorbic Acid 1000 mg<br>* 1000 mg ascorbic acid (Vitamin C) for 14 days post-op after an elective gynecological surgery.<br>|
| Placebo Comparator: Women on a placebo regimen<br>Women who are undergoing elective gynecological surgeries and who are randomized to take placebo for 14 days | Other: Placebo<br>* Placebo pills for 14 days post-op after an elective gynecological surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants who experienced clinically diagnosed and treated UTI. | Urinary tract infection is diagnosed by a positive urine culture. | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with asymptomatic bacteruria | Participants with positive urine culture but no symptoms | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin C, CAUTI, Ascorbic Acid