Catheter-Associated Urinary Tract Infection
Conditions
Keywords
Ascorbic acid, Vitamin C, Elective Gynecologic surgeries, CAUTI
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.
Interventions
1000mg Ascorbic acid orally daily started on the day of elective gynecological surgery for 10 days
DRUGPlacebo
Placebo tablet daily starting day of elective gynecological surgery for 10 days
Sponsors
Moscow State University of Medicine and Dentistry
American University of Beirut Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Masking description
Double blinded
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of UTI | 30 days | The Primary endpoint is the proportion of participants who experience a clinically diagnosed and treated UTI as evidenced by a positive urine culture. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Asymptomatic UTI | 30 days | The proportion of participants with a positive urine culture, while asymptomatic (asymptomatic bacteriuria) at the end of the study period |
Countries
Russia
Contacts
Primary ContactTony Bazi, M.D.
Backup ContactGeorge kasyan, M.D.
Outcome results
None listed