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Vitamin C Effectiveness in Preventing Urinary Tract Infections After Gynecological Surgeries

Primary Purpose

Catheter-Associated Urinary Tract Infection

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Ascorbic Acid 1000 MG
Placebo
Sponsored by
American University of Beirut Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Catheter-Associated Urinary Tract Infection focused on measuring Ascorbic acid, Vitamin C, Elective Gynecologic surgeries, CAUTI

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Vitamin C

    Placebo

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

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

    Full Information

    First Posted
    June 10, 2023
    Last Updated
    June 21, 2023
    Sponsor
    American University of Beirut Medical Center
    Collaborators
    Moscow State University of Medicine and Dentistry
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05913180
    Brief Title
    Vitamin C Effectiveness in Preventing Urinary Tract Infections After Gynecological Surgeries
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 15, 2023 (Anticipated)
    Primary Completion Date
    August 15, 2025 (Anticipated)
    Study Completion Date
    August 15, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    American University of Beirut Medical Center
    Collaborators
    Moscow State University of Medicine and Dentistry

    4. Oversight

    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
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Catheter-Associated Urinary Tract Infection
    Keywords
    Ascorbic acid, Vitamin C, Elective Gynecologic surgeries, CAUTI

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Masking Description
    Double blinded
    Allocation
    Randomized
    Enrollment
    180 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Vitamin C
    Arm Type
    Active Comparator
    Arm Description
    1000mg Ascorbic acid daily starting the day of elective gynecological surgery for 10 days
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo daily starting the day of elective gynecological surgery for 10 days
    Intervention Type
    Drug
    Intervention Name(s)
    Ascorbic Acid 1000 MG
    Other Intervention Name(s)
    Vitamin C
    Intervention Description
    1000mg Ascorbic acid orally daily started on the day of elective gynecological surgery for 10 days
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo tablet daily starting day of elective gynecological surgery for 10 days
    Primary Outcome Measure Information:
    Title
    Incidence of UTI
    Description
    The Primary endpoint is the proportion of participants who experience a clinically diagnosed and treated UTI as evidenced by a positive urine culture.
    Time Frame
    30 days
    Secondary Outcome Measure Information:
    Title
    Asymptomatic UTI
    Description
    The proportion of participants with a positive urine culture, while asymptomatic (asymptomatic bacteriuria) at the end of the study period
    Time Frame
    30 days

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tony Bazi, M.D.
    Phone
    9611350000
    Email
    tb04@aub.edu.lb
    First Name & Middle Initial & Last Name or Official Title & Degree
    George kasyan, M.D.
    Email
    g.kasyan@outlook.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tony Bazi, M.D.
    Organizational Affiliation
    American University of Beirut Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    25882919
    Citation
    Foxman B, Cronenwett AE, Spino C, Berger MB, Morgan DM. Cranberry juice capsules and urinary tract infection after surgery: results of a randomized trial. Am J Obstet Gynecol. 2015 Aug;213(2):194.e1-8. doi: 10.1016/j.ajog.2015.04.003. Epub 2015 Apr 13.
    Results Reference
    background
    PubMed Identifier
    17611821
    Citation
    Ochoa-Brust GJ, Fernandez AR, Villanueva-Ruiz GJ, Velasco R, Trujillo-Hernandez B, Vasquez C. Daily intake of 100 mg ascorbic acid as urinary tract infection prophylactic agent during pregnancy. Acta Obstet Gynecol Scand. 2007;86(7):783-7. doi: 10.1080/00016340701273189.
    Results Reference
    background
    PubMed Identifier
    11730365
    Citation
    Carlsson S, Wiklund NP, Engstrand L, Weitzberg E, Lundberg JO. Effects of pH, nitrite, and ascorbic acid on nonenzymatic nitric oxide generation and bacterial growth in urine. Nitric Oxide. 2001 Dec;5(6):580-6. doi: 10.1006/niox.2001.0371.
    Results Reference
    background
    PubMed Identifier
    15111369
    Citation
    Trautner BW, Darouiche RO. Catheter-associated infections: pathogenesis affects prevention. Arch Intern Med. 2004 Apr 26;164(8):842-50. doi: 10.1001/archinte.164.8.842.
    Results Reference
    background
    PubMed Identifier
    21148516
    Citation
    Barbosa-Cesnik C, Brown MB, Buxton M, Zhang L, DeBusscher J, Foxman B. Cranberry juice fails to prevent recurrent urinary tract infection: results from a randomized placebo-controlled trial. Clin Infect Dis. 2011 Jan 1;52(1):23-30. doi: 10.1093/cid/ciq073.
    Results Reference
    background
    PubMed Identifier
    24082842
    Citation
    Hickling DR, Nitti VW. Management of recurrent urinary tract infections in healthy adult women. Rev Urol. 2013;15(2):41-8.
    Results Reference
    background
    PubMed Identifier
    18559747
    Citation
    Wald HL, Ma A, Bratzler DW, Kramer AM. Indwelling urinary catheter use in the postoperative period: analysis of the national surgical infection prevention project data. Arch Surg. 2008 Jun;143(6):551-7. doi: 10.1001/archsurg.143.6.551.
    Results Reference
    background

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    Vitamin C Effectiveness in Preventing Urinary Tract Infections After Gynecological Surgeries

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