Vitamin C Effectiveness in Preventing Urinary Tract Infections After Gynecological Surgeries
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ascorbic Acid 1000 MG, Placebo.
- Who it may be relevant to
- Registry conditions: Catheter-Associated Urinary Tract Infection. Basic parameters: 18 years — 80 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Russia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Drug Ascorbic Acid 1000 MG
1000mg Ascorbic acid orally daily started on the day of elective gynecological surgery for 10 days - Drug Placebo
Placebo tablet daily starting day of elective gynecological surgery for 10 days
Primary outcome measures
- Incidence of UTI [Time frame: 30 days]
Secondary outcome measures (1)
- Asymptomatic UTI [Time frame: 30 days]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Russia · 1 center
- Moscow State University of Medicine and Dentistry — Moscow
Publications
- 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. PMID 25882919
- 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. PMID 17611821
- 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. PMID 11730365
- 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. PMID 15111369
- 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. PMID 21148516
- Hickling DR, Nitti VW. Management of recurrent urinary tract infections in healthy adult women. Rev Urol. 2013;15(2):41-8. PMID 24082842
- 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. PMID 18559747
Identifiers
NCT: NCT05913180 · 62/137-H/77-2023-25-2295