Vitamin C for the Prevention of UTI in Women Who Undergo Elective Gynecological Surgeries

Catheter-Associated Urinary Tract Infection, Ascorbic Acid Clinical Trial

Official title:

Vitamin C for the Prevention of Catheter-associated Urinary Tract Infections in Women Who Undergo Elective Gynecological Surgeries: a Study Protocol for a Randomized Double Blinded Controlled Trial.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04261036
• Other study ID #: OGY.TB.09/BIO-2017-0609
• Status: Withdrawn
• Phase: Early Phase 1
• Start date: July 20, 2019
• Est. completion date: October 1, 2021

Study information

• Verified date: May 2023
• Source: American University of Beirut Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This open-label randomized trial aims at assessing the role of Vitamin C pills in the prevention of catheter-associated urinary tract infections in women undergoing elective gynecological surgeries.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Non pregnant women at least 18 years of age visiting the Preadmission unit (PAU) or the OBGYN floor (7N), presenting for elective GYN surgery at the American University of Beirut Medical Center (AUBMC).

Exclusion Criteria:

• Any women with the following:

1. Nephrolithiasis

2. Congenital anomaly or neurogenic bladder

3. Allergy to ascorbic acid

4. Who require therapeutic anticoagulant medicine during the 6 weeks after surgery

5. Surgery did involve a fistula repair or a vaginal mesh removal

6. Positive Urinalysis in the PAU

7. Recurrent UTI's

8. Diabetes

9. G6PD

10. Hemochromatosis

11. Renal disorders

Patients already taking Vitamin C supplementation will also be excluded from the study.

Related Conditions & MeSH terms

• Catheter-Associated Urinary Tract Infection, Ascorbic Acid
• Infections
• Urinary Tract Infections

Intervention

Drug:
• Ascorbic Acid 1000 mg
1000 mg ascorbic acid (Vitamin C) for 14 days post-op after an elective gynecological surgery.

Other:
• Placebo
Placebo pills for 14 days post-op after an elective gynecological surgery.

Locations

Country	Name	City	State
Lebanon	American University of Beirut Medical Center	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
American University of Beirut Medical Center

Country where clinical trial is conducted

Lebanon, 

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	Proportion of participants who experienced clinically diagnosed and treated UTI.	Urinary tract infection is diagnosed by a positive urine culture.	14 days
Secondary	Proportion of participants with asymptomatic bacteruria	Participants with positive urine culture but no symptoms	14 days