Clinical trial NCT05913180: 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
Overall status: RECRUITING
Phase: PHASE2
Conditions: Catheter-Associated Urinary Tract Infection
Keywords: Ascorbic acid
Vitamin C
Elective Gynecologic surgeries
CAUTI
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
Collaborators: name: Moscow State University of Medicine and Dentistry
First posted: 2023-06-22
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Incidence of UTI
timeFrame: 30 days
Secondary outcomes:
measure: Asymptomatic UTI
timeFrame: 30 days
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Moscow State University of Medicine and Dentistry
Study officials:
affiliation: American University of Beirut Medical Center
name: Tony Bazi, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
citation: Hickling DR, Nitti VW. Management of recurrent urinary tract infections in healthy adult women. Rev Urol. 2013;15(2):41-8.
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.