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Vitamin C Effectiveness in Preventing Urinary Tract Infections After Gynecological Surgeries

NCT ID: NCT05913180

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-19

Study Completion Date

2026-08-15

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.

Conditions

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Catheter-Associated Urinary Tract Infection

Keywords

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Ascorbic acid Vitamin C Elective Gynecologic surgeries CAUTI

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers
Double blinded

Study Groups

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Vitamin C

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

Group Type ACTIVE_COMPARATOR

Ascorbic Acid 1000 MG

Intervention Type DRUG

1000mg Ascorbic acid orally daily started on the day of elective gynecological surgery for 10 days

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Ascorbic Acid 1000 MG

1000mg Ascorbic acid orally daily started on the day of elective gynecological surgery for 10 days

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Vitamin C

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Moscow State University of Medicine and Dentistry

OTHER

Sponsor Role collaborator

American University of Beirut Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Tony Bazi

Associate Professor of Clinical Obstetrics and Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tony Bazi, M.D.

Role: PRINCIPAL_INVESTIGATOR

American University of Beirut Medical Center

Locations

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Moscow State University of Medicine and Dentistry

Moscow, , Russia

Site Status RECRUITING

Countries

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Russia

Central Contacts

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Tony Bazi, M.D.

Role: CONTACT

Phone: 9611350000

Email: [email protected]

George kasyan, M.D.

Role: CONTACT

Email: [email protected]

Facility Contacts

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George Kasyan

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 25882919 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17611821 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11730365 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15111369 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21148516 (View on PubMed)

Hickling DR, Nitti VW. Management of recurrent urinary tract infections in healthy adult women. Rev Urol. 2013;15(2):41-8.

Reference Type BACKGROUND
PMID: 24082842 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18559747 (View on PubMed)

Other Identifiers

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

Identifier Type: -

Identifier Source: org_study_id