Catheter-Associated Urinary Tract InfectionPhase 2NCT05913180
Vitamin C Effectiveness in Preventing Urinary Tract Infections After Gynecological Surgeries
A Phase 2 study testing Ascorbic Acid 1000 MG in people with Catheter-Associated Urinary Tract Infection, run by American University of Beirut Medical Center at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Catheter-Associated Urinary Tract Infection
- What is being tested?
- Ascorbic Acid 1000 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteRussia
- Study dates
- 19 Sep 2023to 15 Aug 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Nonpregnant women
- 18 years of age or older
- Undergoing elective GYN surgery
Who cannot join
- 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
Show all 13Show fewer
- Gynecological surgery involving fistula repair or a vaginal mesh removal
- Positive Urinalysis in the pre-admission unit
- Recurrent UTIs
- Diabetes
- G6PD
- Hemochromatosis
- Renal disorders
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- Ascorbic Acid 1000 MG, Placebo
- Keywords
- Ascorbic acid, Vitamin C, Elective Gynecologic surgeries, CAUTI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ascorbic Acid 1000 MGDrug
Also called Vitamin C
1000mg Ascorbic acid orally daily started on the day of elective gynecological surgery for 10 days
PlaceboDrug
Placebo tablet daily starting day of elective gynecological surgery for 10 days
| Study group | Role | What they receive |
|---|---|---|
| Vitamin C | Active comparator | 1000mg Ascorbic acid daily starting the day of elective gynecological surgery for 10 days Receives: Drug: Ascorbic Acid 1000 MG |
| Placebo | Placebo comparator | Placebo daily starting the day of elective gynecological surgery for 10 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (1)
Asymptomatic UTI
The proportion of participants with a positive urine culture, while asymptomatic (asymptomatic bacteriuria) at the end of the study period
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start19 Sep 2023
- Primary completion15 Aug 2026
- Study completion15 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Catheter-Associated Urinary Tract InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Moscow State University of Medicine and Dentistry
- Responsible party
- Principal investigator, Tony Bazi, American University of Beirut Medical Center
- Investigators
- Tony Bazi, M.D., Principal investigator, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05913180
- Sponsor's protocol ID
- 62/137-H/77-2023-25-2295
- Status last verified
- Oct 2026
- First submitted
- 10 Jun 2023
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25882919Ochoa-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.
PubMed 17611821Carlsson 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.
PubMed 11730365Trautner 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.
PubMed 15111369Barbosa-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.
PubMed 21148516Hickling DR, Nitti VW. Management of recurrent urinary tract infections in healthy adult women. Rev Urol. 2013;15(2):41-8.
PubMed 24082842Wald 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.
PubMed 18559747
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05913180
- Acronym / sponsor ID
- 62/137-H/77-2023-25-2295
- Keywords
- Ascorbic acid, Vitamin C, Elective Gynecologic surgeries, CAUTI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Collaborators
- Moscow State University of Medicine and Dentistry
- Study start
- 19 Sep 2023 (actual)
- Primary completion
- 15 Aug 2026 (actual)
- Study completion
- 15 Aug 2026 (actual)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin C | Active comparator | Drug: Ascorbic Acid 1000 MG1000mg Ascorbic acid daily starting the day of elective gynecological surgery for 10 days |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo daily starting the day of elective gynecological surgery for 10 days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Nonpregnant women
- 18 years of age or older
- Undergoing elective GYN surgery
Key exclusion criteria (13 listed)
- Pregnant women
- Already taking Vitamin C supplementation
- Nephrolithiasis
- Congenital anomaly or neurogenic bladder
- Allergy to ascorbic acid
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ascorbic Acid 1000 MGAlso: Vitamin C1000mg Ascorbic acid orally daily started on the day of elective gynecological surgery for 10 days | Drug | Vitamin C |
| PlaceboPlacebo tablet daily starting day of elective gynecological surgery for 10 days | Drug | Placebo |
Primary outcome
Incidence of UTI
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.
1 secondary outcome
Asymptomatic UTI
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Background: PubMed 25882919Foxman 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.
- Background: PubMed 17611821Ochoa-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.
- Background: PubMed 11730365Carlsson 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.
- Background: PubMed 15111369Trautner 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.
- Background: PubMed 21148516Barbosa-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.
- Background: PubMed 24082842Hickling DR, Nitti VW. Management of recurrent urinary tract infections in healthy adult women. Rev Urol. 2013;15(2):41-8.
- Background: PubMed 18559747Wald 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.
- Individual participant dataSharing planned: No
Related trials for Catheter-Associated Urinary Tract Infection
Not yet recruitingObservational study
Evaluate of the Use of Uromune as a Potential Non-antibiotic Prophylactic Strategy for Catheter-associated Urinary Tract Infection in Patients With Long-term Catheterization.
Catheter-Associated Urinary Tract Infections (CAUTIs)
Recruiting
Effectiveness of the NowCath Foley in Reducing Catheter-Associated UTIs and Blockages in Long-Term Indwelling Catheter Users (REDUCE)
Urinary Catheters, Urinary Catheterization
Recruiting
Comparative Study Between Foley and T-Control® Catheter in Patients With Long-term Catheterization
Catheter-Associated Urinary Tract Infection, Catheter Related Complication
Active, not recruiting
Early (Postoperative Day 3) Versus Standard (Postoperative Day 6) Urethral Catheter Removal After Living Donor Kidney Transplantation
Catheter-Associated Urinary Tract Infections (CAUTIs), Kidney Transplantation
Recruiting
Hydrogen Peroxide and Ultraviolet Light for Disinfecting Surfaces in Intensive Care Units
Infection, Hospital, Antimicrobial
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tony Bazi, M.D. principal investigator
American University of Beirut Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ascorbic Acid 1000 MG in people with Catheter-Associated Urinary Tract Infection, run by American University of Beirut Medical Center at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of UTI (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05913180, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.