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Antibiotics

Antibiotic Group for Stress Incontinence

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 4 weeks after the procedure

Awards & highlights

Study 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.Check my eligibility

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).See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate of urinary tract infection (UTI)

Secondary outcome measures

Rate of postoperative urinary retention

Rates of other postoperative complications

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Atlantic Health SystemLead Sponsor

52 Previous Clinical Trials

6,217 Total Patients Enrolled

Erika Wasenda, MDPrincipal InvestigatorAtlantic Health System

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit for the number of individuals enrolled in this research endeavor?

"Affirmative. Information on clinicaltrials.gov confirms that this investigation is actively seeking suitable candidates. Initially shared on October 24th, 2023, the latest revision was made on February 8th, 2024. The study aims to enlist a total of 70 participants at one designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Effectiveness of Prophylactic Antibiotics for Urethral Bulking

Erika Wasenda 2023. "The Effectiveness of Prophylactic Antibiotics for Urethral Bulking". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06261736.

All > Urinary Incontinence