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Antibiotics

Prophylactic Antibiotics for Preventing Urinary Tract Infections

N/A

Recruiting

Led By Erika Wasenda, MD

Research Sponsored by Atlantic Health System

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 and over

Patients scheduled to undergo a urethral bulking procedure

Must not have

History of recurrent urinary tract infections

Known history of urinary retention

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 4 weeks after the procedure

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if giving antibiotics before a urethral bulking procedure can help prevent urinary tract infections afterwards.

Who is the study for?

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.

What is being tested?

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).

What are the potential side effects?

Potential side effects from prophylactic antibiotics may include allergic reactions, gastrointestinal discomfort like nausea or diarrhea, and possibly developing resistance to the antibiotic used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had multiple urinary tract infections.

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

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I cannot tolerate oral antibiotics.

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I am having other surgeries along with urethral bulking.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 4 weeks after the procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 4 weeks after the procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 4 weeks after the procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of urinary tract infection (UTI)

Secondary study objectives

Rate of postoperative urinary retention

Rates of other postoperative complications

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: No antibiotic groupExperimental Treatment1 Intervention

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

Group II: Antibiotic GroupExperimental Treatment1 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.

0 / 6Eligibility criteria met