Prophylactic Antibiotics for Urinary Tract Infection
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether a single dose of antibiotics before a common bladder procedure can prevent urinary tract infections (UTIs) afterward. It focuses on women planning to undergo a urethral bulking procedure for stress or mixed urinary incontinence. Women who test negative for UTIs in their pre-procedure check-up and are not currently experiencing recurrent UTIs or other related conditions may qualify to participate. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, and this research aims to understand how it benefits more patients.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but if you are currently taking daily antibiotics, you cannot participate. It's best to discuss your specific medications with the trial team.
What is the safety track record for prophylactic antibiotics?
Research has shown that Bactrim, a combination of two medicines, can help prevent urinary tract infections (UTIs). However, it may cause side effects such as high potassium levels and sudden kidney problems. Although these side effects are uncommon, they can occur.
Macrobid, which contains nitrofurantoin, offers another option for preventing UTIs and typically causes few side effects. Rarely, long-term use may lead to lung, nerve, or liver issues, but this is uncommon.
In summary, both Bactrim and Macrobid are generally safe for preventing UTIs, though they can have side effects. Discuss any concerns with a healthcare provider.12345Why are researchers enthusiastic about this study treatment?
Unlike the standard approach for preventing urinary tract infections (UTIs), which often involves taking antibiotics over an extended period, the prophylactic antibiotics in this trial are administered as a single oral dose. This method is unique because it simplifies the treatment regimen, potentially reducing the risk of antibiotic resistance that comes with long-term usage. Researchers are excited about this approach because it aims to offer effective protection with minimal antibiotic exposure, making it a promising option for patients undergoing urethral bulking procedures.
What evidence suggests that prophylactic antibiotics might be an effective treatment for preventing post-procedural urinary tract infections?
Research has shown that preventive antibiotics can lower the risk of urinary tract infections (UTIs). In this trial, participants in the Prophylactic Antibiotic Group will receive either Bactrim, which contains trimethoprim and sulfamethoxazole, or Macrobid (nitrofurantoin) if they are allergic to sulfonamides. Bactrim has been found to nearly halve the rate of UTI episodes, while Macrobid is also effective, with studies showing a significant reduction in risk compared to no treatment. Both antibiotics are well-known for preventing recurring UTIs, highlighting their potential to reduce infections after medical procedures. This evidence supports the use of preventive antibiotics to help stop UTIs around certain medical procedures.26789
Who Is on the Research Team?
Katherine Amin, MD
Principal Investigator
University of Miami
Are You a Good Fit for This Trial?
This trial is for women aged 18 or older who plan to have urethral bulking for stress or mixed urinary incontinence, have no current UTI, a low amount of urine left after peeing, and can speak English or Spanish.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single oral dose of prophylactic antibiotics or no antibiotics at the time of urethral bulking procedure
Follow-up
Participants are monitored for incidence of post-procedural urinary tract infection (UTI)
What Are the Treatments Tested in This Trial?
Interventions
- Prophylactic Antibiotics
Trial Overview
The study tests if taking a single dose of either Bactrim or Macrobid antibiotics before an outpatient urethral bulking procedure helps prevent urinary tract infections afterward. Participants are randomly assigned to one of the antibiotic groups.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants in this group will receive a single oral dose of either Bactrim (800 mg sulfamethoxazole + 160 mg trimethoprim) or if allergic to sulfonamides, a single oral dose of Macrobid (100 mg nitrofurantoin) at the time of standard of care clinic based urethral bulking procedure.
Participants in this group will not receive prophylactic antibiotics at the time of standard of care clinic based urethral bulking procedure.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Miami
Lead Sponsor
Citations
Recurrent Urinary Tract Infection in Adult Patients, Risk ... - PMC
Antibiotics regimens used included Nitrofurantoin, trimethoprim and Bactrim resulted in close to 50% reduction in the rate of UTI episodes. The benefit ...
Antibiotic Prophylaxis and Recurrent Urinary Tract Infection ...
Long-term, low-dose trimethoprim–sulfamethoxazole was associated with a decreased number of urinary tract infections in predisposed children.
Comparative effectiveness of oral antibiotics to treat ...
Simulated outcome results indicate the 2.5th and 97.5th percentiles for the aRR of each comparator based on random replacement of 20% of ...
Antibiotics for Preventing Recurrent Urinary Tract Infection
Study quality was low. In the 11 placebo-controlled trials, the risk for developing UTI was 85% lower with prophylaxis in comparison with ...
2273. Outcomes of Trimethoprim/Sulfamethoxazole as ... - PMC
Our findings suggest that TMP/SMX can be safe and effective as definitive therapy for ESBL-E UTI. The major AE are hyperkalemia and AKI.
Antibiotics for Preventing Recurrent Urinary Tract Infection
In the 11 placebo-controlled trials, the risk for developing UTI was 85% lower with prophylaxis in comparison with placebo (risk ratio [RR], 0.15; 95% CI, 0.08– ...
A systematic review and meta‐analysis with active comparator ...
Our meta‐analyses and pharmacovigilance study suggested SMX‐TMP was associated with increased risk of ADEs compared to other antibiotics ...
BACTRIM™ sulfamethoxazole and trimethoprim DS (double ...
Adults: The usual adult dosage in the treatment of urinary tract infections is 1 BACTRIM DS. (double strength) tablet or 2 BACTRIM tablets every 12 hours for 10 ...
9.
rochesterpatientsafety.com
rochesterpatientsafety.com/Images_Content/Site1/Files/Pages/Guidelines-treatment-UTI.pdfUTI Treatment Guidelines
Data suggests that oral beta-lactams are inferior to Bactrim or fluoroquinolones for pyelonephritis. • Initial dose of IV ceftriaxone and longer treatment ...
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