Prophylactic Antibiotics for Preventing Urinary Tract Infections

Overseen By Tess Gao, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Atlantic Health System

Disqualifiers: Recurrent UTIs, Urinary retention, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether taking prophylactic antibiotics (antibiotics given as a preventive measure) before a urethral bulking procedure can prevent urinary tract infections (UTIs) afterward. Participants will be divided into two groups: one will receive a single dose of an antibiotic based on their medical history, while the other will not receive any antibiotics. The trial aims to determine if antibiotics can lower the risk of UTIs after the procedure. It seeks participants scheduled for a urethral bulking procedure who do not have a history of frequent UTIs or allergies to many antibiotics. As an unphased trial, it offers a unique opportunity to contribute to medical knowledge and potentially improve preventive care for future patients.

Do I need to stop my current medications for this trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that prophylactic antibiotics are likely to be safe?

Research has shown that preventive antibiotics can help reduce urinary tract infections (UTIs). In one study, patients who took these antibiotics experienced fewer UTIs than those who did not. Specifically, only 12% of patients on antibiotics developed a UTI, compared to 36% of those who did not take them.

However, considering possible side effects is important. Some reports mention a higher chance of mild issues, such as yeast infections affecting the skin and mouth. Continuous antibiotic use can also lead to other side effects, so weighing the benefits and risks is crucial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for preventing urinary tract infections (UTIs) typically involve taking antibiotics after symptoms appear. However, the use of prophylactic antibiotics, as seen in this trial, involves administering a one-time dose before a urethral bulking procedure to prevent infections from occurring in the first place. This approach is unique because it tailors the antibiotic choice to individual patient profiles, taking into account allergies, medical history, and current medications, which could potentially reduce the risk of side effects and antibiotic resistance. Researchers are excited because this method could offer a more personalized and proactive strategy for preventing UTIs, possibly leading to better patient outcomes and fewer recurring infections.

What evidence suggests that prophylactic antibiotics are effective in preventing urinary tract infections?

Research has shown that taking antibiotics before certain procedures can greatly lower the chance of getting a urinary tract infection (UTI). In some studies, people who used antibiotics were 85% less likely to get a UTI compared to those who didn't. One study found that only 12% of people who took antibiotics got UTIs, while 36% of those who didn't take them did. This trial will compare two groups: one group will receive a one-time dose of an oral antibiotic before the urethral bulking procedure, while the other group will not. This evidence suggests that antibiotics can help prevent infections. However, antibiotics can also cause side effects, so it's important to consider both the benefits and risks. ^{1 3 6 7 8}

Who Is on the Research Team?

Erika Wasenda, MD

Principal Investigator

Atlantic Health System

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are scheduled for a urethral bulking procedure to treat urinary incontinence. It's not suitable for those with frequent UTIs, known urinary retention issues, allergies to many antibiotics, inability to take oral antibiotics, other surgeries at the same time as bulking, or if pregnant/breastfeeding.

Inclusion Criteria

I am scheduled for a procedure to help control my urine flow.

Exclusion Criteria

Pregnant or breastfeeding

I have had multiple urinary tract infections.

I have a history of not being able to empty my bladder completely.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo urethral bulking procedure with or without prophylactic antibiotics

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure, focusing on UTI and other complications

4 weeks

1-2 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Prophylactic antibiotics

Trial Overview

The study is testing whether giving patients antibiotics before their urethral bulking procedure can prevent infections afterwards. Some participants will receive no antibiotics (control group), while others will get prophylactic antibiotics (test group).

How Is the Trial Designed?

Group I: No antibiotic group Experimental Treatment 1 Intervention

Those randomized to this group will not receive an antibiotic prior to the urethral bulking procedure.

Group II: Antibiotic Group Experimental Treatment 1 Intervention

Those randomized to this group will receive a one-time dose of an oral antibiotic prior to the urethral bulking procedure. The antibiotic will be based on the participants' allergies, medical history, and current medication list.

Prophylactic antibiotics is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Prophylactic Antibiotics for:

• Prevention of urinary tract infections in urethral bulking procedures

Approved in Canada as Prophylactic Antibiotics for:

• Prevention of urinary tract infections in urethral bulking procedures

Approved in European Union as Prophylactic Antibiotics for:

• Prevention of surgical site infections and urinary tract infections in various surgical procedures, including urethral bulking

Who Is Running the Clinical Trial?

Atlantic Health System

Lead Sponsor

Trials

58

Recruited

9,400+

Published Research Related to This Trial

Prophylactic antibiotic therapy is increasingly used in urology, particularly for preventing post-operative septic complications, with transurethral resection of the prostate being the most common procedure associated with this practice.

Numerous randomized studies have confirmed the efficacy and usefulness of antibiotic prophylaxis in urological operations, supporting its role in improving patient safety during and after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prophylactic antibiotic therapy in urology]. Gattegno, B.[2006]

Perioperative antibiotic prophylaxis is crucial for preventing surgical site and urinary tract infections during urological procedures, especially considering factors like contamination risk, surgery duration, and patient comorbidities.

While effective, antibiotic prophylaxis should be used judiciously as it contributes to overall antibiotic consumption and resistance, and it should always be complemented by proper hygiene and surgical techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Antibiotic prophylaxis in urology]. Wagenlehner, FM., Grabe, M., Naber, KG., et al.[2021]

Antimicrobial prophylaxis may be beneficial even in patients with preoperatively sterile urine undergoing transurethral surgery, suggesting a broader application of preventive measures against urinary tract infections.

New fluoroquinolones are recommended for prophylaxis due to their high tissue concentrations, effective coverage of uropathogens, and convenient oral administration, making them a promising option for this type of surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quinolone prophylaxis in transurethral surgery. Gasser, TC.[2018]

Antibiotic prophylaxis is commonly used in urological procedures to prevent infections, but there is a lack of strong evidence to determine the best prophylactic strategy, highlighting the need for careful selection based on available data.

Due to the growing issue of antimicrobial resistance, physicians are urged to practice antibiotic stewardship by tailoring prophylaxis to individual patient characteristics and infection risk factors, rather than using a one-size-fits-all approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Profilassi antibiotica nelle procedure urologiche. Rizzo, M., Trombetta, C.[2019]

This systematic review and meta-analysis aims to evaluate the effectiveness of different antibiotic prophylaxis strategies versus placebo in preventing postoperative urinary tract infections (UTIs) and asymptomatic bacteriuria in patients undergoing transurethral resection of bladder tumors, addressing a significant clinical controversy.

The study will analyze data from randomized controlled trials and non-randomized studies, with a focus on understanding the necessity of antibiotic use to prevent UTIs, which is crucial for combating rising antimicrobial resistance rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antibiotic prophylaxis in transurethral resection of bladder tumours: study protocol for a systematic review and meta-analysis. Bausch, K., Aghlmandi, S., Sutter, SU., et al.[2022]

In a study of 179 urological procedures, ceftriaxone was the most commonly used prophylactic antibiotic, but there was a concerning low susceptibility of common bacteria like E. coli and K. pneumoniae to this antibiotic, highlighting potential risks for postoperative infections.

The findings suggest that antibiotic prophylaxis should be tailored based on the type of urological procedure and the local bacterial profile, with aminoglycosides being a recommended alternative due to their better activity against resistant strains.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of antibiotic prophylaxis in patients undergoing urologic procedures in an academic hospital Surabaya: A retrospective study. Asmarawati, TP., Djojodimedjo, T., Andhika, DP., et al.[2023]

Antimicrobial prophylaxis is beneficial even when urine is sterile before transurethral surgery, suggesting it can help prevent urinary tract infections during these procedures.

New fluoroquinolones are particularly effective for prophylaxis due to their high tissue concentrations, broad antimicrobial coverage, and the convenience of oral administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prevention using quinolones in transurethral surgery]. Gasser, TC.[2006]

Antibiotic prophylaxis is strongly supported for transurethral resection of the prostate (TURP) and prostate biopsy, based on high-quality evidence, while other urologic procedures lack sufficient studies to recommend routine use.

For procedures like cystoscopy and urodynamic investigations, moderate to low evidence suggests that antibiotic prophylaxis may not be necessary, highlighting the need for careful consideration of antibiotic use to avoid resistance and side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antibiotic prophylaxis in urologic procedures: a systematic review. Bootsma, AM., Laguna Pes, MP., Geerlings, SE., et al.[2022]

There is currently no clear consensus on antibiotic prophylaxis for urological procedures due to variations in study designs and definitions of infectious complications, which may lead to unnecessary risks for patients and increased healthcare costs.

Most experts agree that ensuring patients have sterile urine before urological interventions is crucial, and that properly timed oral antibiotic prophylaxis can be as effective as intravenous options for preventing infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative antibiotic prophylaxis in urology. Grabe, M.[2019]

Prophylactic antibiotics are effective in reducing wound infections after specific surgeries, such as colorectal surgery and high-risk gastroduodenal or biliary surgeries, based on a review of literature up to June 1982.

In clean surgeries like cardiac and orthopedic procedures, the potential high morbidity from infections justifies the use of antibiotics, despite the low risk of infection, while the effectiveness in other procedures like abdominal hysterectomy and cesarean sections remains unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antibiotic prophylaxis in surgical procedures. A critical analysis of the literature. Guglielmo, BJ., Hohn, DC., Koo, PJ., et al.[2019]

Perioperative antimicrobial prophylaxis is effective in reducing the risk of postoperative infections in urological surgery, according to modern guidelines discussed in the review.

Despite its benefits, the effectiveness of prophylaxis can vary, indicating that ongoing research is needed to optimize these methods for different urological procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Antimicrobial prophylaxis in urological surgery]. Antelava, NA., Pirtskhalaĭshvili, NN., Antelava, AV., et al.[2008]

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Review of Antibiotic Prophylaxis in the Management of ...

Continuous antibiotic prophylaxis, while effective in the short-term, carries many risks including medication side effects.