Vitamin C Effectiveness in Preventing Urinary Tract Infections After Gynecological Surgeries
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| ClinicalTrials.gov Identifier: NCT05913180 |
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Recruitment Status :
Not yet recruiting
First Posted : June 22, 2023
Last Update Posted : June 22, 2023
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Sponsor:
American University of Beirut Medical Center
Collaborator:
Moscow State University of Medicine and Dentistry
Information provided by (Responsible Party):
Tony Bazi, American University of Beirut Medical Center
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Catheter-Associated Urinary Tract Infection | Drug: Ascorbic Acid 1000 MG Drug: Placebo | Phase 2 |
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 (Clinical Trial) |
| Estimated Enrollment : | 180 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Care Provider) |
| Masking Description: | Double blinded |
| Primary Purpose: | Prevention |
| Official Title: | Vitamin C for the Prevention of Catheter-associated Urinary Tract Infections in Women Who Undergo Elective Gynecological Surgeries: a Randomized Double-blinded Controlled Trial |
| Estimated Study Start Date : | June 15, 2023 |
| Estimated Primary Completion Date : | August 15, 2025 |
| Estimated Study Completion Date : | August 15, 2025 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Vitamin C
1000mg Ascorbic acid daily starting the day of elective gynecological surgery for 10 days
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Drug: Ascorbic Acid 1000 MG
1000mg Ascorbic acid orally daily started on the day of elective gynecological surgery for 10 days
Other Name: Vitamin C |
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Placebo Comparator: Placebo
Placebo daily starting the day of elective gynecological surgery for 10 days
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Drug: Placebo
Placebo tablet daily starting day of elective gynecological surgery for 10 days |
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Gender Based Eligibility: | Yes |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05913180
Contacts
| Contact: Tony Bazi, M.D. | 9611350000 | tb04@aub.edu.lb | |
| Contact: George kasyan, M.D. | g.kasyan@outlook.com |
Sponsors and Collaborators
American University of Beirut Medical Center
Moscow State University of Medicine and Dentistry
Investigators
| Principal Investigator: | Tony Bazi, M.D. | American University of Beirut Medical Center |
Publications:
| Responsible Party: | Tony Bazi, Associate Professor of Clinical Obstetrics and Gynecology, American University of Beirut Medical Center |
| ClinicalTrials.gov Identifier: | NCT05913180 |
| Other Study ID Numbers: |
62/137-H/77-2023-25-2295 |
| First Posted: | June 22, 2023 Key Record Dates |
| Last Update Posted: | June 22, 2023 |
| Last Verified: | June 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| 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 |
Keywords provided by Tony Bazi, American University of Beirut Medical Center:
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Ascorbic acid Vitamin C Elective Gynecologic surgeries CAUTI |
Additional relevant MeSH terms:
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Infections Communicable Diseases Urinary Tract Infections Disease Attributes Pathologic Processes Urologic Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases |
Male Urogenital Diseases Ascorbic Acid Vitamins Micronutrients Physiological Effects of Drugs Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents |