Vitamin C Effectiveness in Preventing Urinary Tract Infections After Gynecological Surgeries

Catheter-Associated Urinary Tract Infection Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05913180
• Other study ID #: 62/137-H/77-2023-25-2295
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 15, 2023
• Est. completion date: August 15, 2025

Study information

• Verified date: June 2023
• Source: American University of Beirut Medical Center
• Contact: Tony Bazi, M.D.
• Phone: 9611350000
• Email: tb04[@]aub.edu.lb
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: August 15, 2025
• Est. primary completion date: August 15, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Catheter-Associated Urinary Tract Infection
• Communicable Diseases
• Infections
• Urinary Tract Infections

Intervention

Drug:
• Ascorbic Acid 1000 MG
1000mg Ascorbic acid orally daily started on the day of elective gynecological surgery for 10 days
• Placebo
Placebo tablet daily starting day of elective gynecological surgery for 10 days

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
American University of Beirut Medical Center	Moscow State University of Medicine and Dentistry

References & Publications (7)

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. — View 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. — View 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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30 days
Secondary	Asymptomatic UTI	The proportion of participants with a positive urine culture, while asymptomatic (asymptomatic bacteriuria) at the end of the study period	30 days