Moscow State University of Medicine and Dentistry
Moscow, Russia
Location status: Recruiting
NCT Number: NCT05913180
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.
Interested in participating?
Request Info18 year–80 year
Female
Interventional
Phase 2
Moscow, Russia
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
1000mg Ascorbic acid orally daily started on the day of elective gynecological surgery for 10 days
Other names: Vitamin C
Placebo tablet daily starting day of elective gynecological surgery for 10 days
Time frame: 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.
Time frame: 30 days
The proportion of participants with a positive urine culture, while asymptomatic (asymptomatic bacteriuria) at the end of the study period
Contact information is provided by the study sponsor or research team.
American University of Beirut Medical Center
Other
Vitamin C for the Prevention of Catheter-associated Urinary Tract Infections in Women Who Undergo Elective Gynecological Surgeries: a Randomized Double-blinded Controlled Trial
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