Prophylactic Antibiotics for Preventing Urinary Tract Infections

Recruiting in Palo Alto (17 mi)

Overseen by Erika Wasenda, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Atlantic Health System

Disqualifiers: Recurrent UTIs, Urinary retention, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to evaluate if prophylactic antibiotics in urethral bulking are effective in reducing postprocedural urinary tract infections.

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.

What data supports the effectiveness of the drug prophylactic antibiotics for preventing urinary tract infections?

Research suggests that using prophylactic antibiotics can help prevent urinary tract infections during certain urological surgeries, as they reduce the risk of infections after procedures. However, the effectiveness can vary, and there is ongoing debate about their use in some cases. ^{1 2 3 4 5}

Is it safe to use prophylactic antibiotics for preventing urinary tract infections?

Prophylactic antibiotics are generally used to prevent infections during urological procedures, but they can have side effects and contribute to antibiotic resistance. It's important to use them carefully and based on strong evidence to minimize risks. ^{1 6 7 8 9}

How do prophylactic antibiotics differ from other drugs for preventing urinary tract infections?

Prophylactic antibiotics are unique because they are given before any signs of infection appear, often as a single dose or short-term course, to prevent infections from occurring, especially in surgical settings. This approach is different from typical treatments that are administered after an infection has developed. ^{1 2 8 10 11}

Research Team

Erika Wasenda, MD

Principal Investigator

Atlantic Health System

Eligibility Criteria

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 18 years old or older.

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.

Trial Timeline

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)

Treatment Details

Interventions

• Prophylactic antibiotics (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).

Participant Groups

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 Canada for the following indications:

Approved in Canada as Prophylactic Antibiotics for:

• Prevention of urinary tract infections in urethral bulking procedures

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Atlantic Health Morristown, NJ

Who Is Running the Clinical Trial?

Atlantic Health System

Lead Sponsor

Trials

58

Patients Recruited

9,400+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Antibiotic prophylaxis in urology]. [2021]

2. France pubmed.ncbi.nlm.nih.gov

[Prevention using quinolones in transurethral surgery]. [2006]

3. England pubmed.ncbi.nlm.nih.gov

Antibiotic prophylaxis in transurethral resection of bladder tumours: study protocol for a systematic review and meta-analysis. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Antibiotic prophylaxis in surgical procedures. A critical analysis of the literature. [2019]

5. Georgia (Republic) pubmed.ncbi.nlm.nih.gov

[Antimicrobial prophylaxis in urological surgery]. [2008]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Antibiotic prophylaxis in urologic procedures: a systematic review. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Perioperative antibiotic prophylaxis in urology. [2019]

8. France pubmed.ncbi.nlm.nih.gov

[Prophylactic antibiotic therapy in urology]. [2006]

9. Italy pubmed.ncbi.nlm.nih.gov

The use of antibiotic prophylaxis in patients undergoing urologic procedures in an academic hospital Surabaya: A retrospective study. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Quinolone prophylaxis in transurethral surgery. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

Profilassi antibiotica nelle procedure urologiche. [2019]