Prophylactic Antibiotics for Urinary Incontinence

Palo Alto (17 mi)

Overseen bySusanne Taege, MD

Age: 18 - 65

Sex: Female

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Ohio State University

Prior Safety Data

Trial Summary

What is the purpose of this trial?The primary aim of this study is to assess the utility of prophylactic oral antibiotics at time of Bulkamid transurethral bulking to reduce the incidence of urinary tract infection (UTI) in the immediate postoperative period. The secondary aims of the study include assessing UTI rates and success rates if patients require temporary indwelling catheter versus intermittent self-catheterization (ISC).

Eligibility Criteria

This trial is for individuals planning to undergo Bulkamid treatment for stress urinary incontinence or mixed urinary incontinence at The Ohio State University. Participants must not have recurrent UTIs, be on daily antibiotics, pregnant, have significant pelvic organ prolapse or immunosuppression, and should not have taken recent antibiotics.

Inclusion Criteria

I am seeing a specialist for urinary incontinence and plan to have a Bulkamid treatment.

I have been diagnosed with stress urinary incontinence.

Exclusion Criteria

I am having other pelvic or urologic surgeries along with my main procedure.

My pelvic organ prolapse is more severe than stage 2.

I cannot take oral antibiotics due to allergies or kidney problems.

I have had 3 or more UTIs in the last year or 2 in the last 6 months.

I am currently on daily antibiotics for prevention.

Treatment Details

The study aims to determine if prophylactic oral antibiotics reduce the risk of UTI after Bulkamid urethral bulking. It compares the effectiveness of a placebo with Bactrim or Macrobid and looks at UTI rates with different catheterization methods post-surgery.

2Treatment groups

Active Control

Placebo Group

Group I: Bactrim or Macrobid (single dose)Active Control1 Intervention

Bactrim (800/160mg) or Macrobid (100 mg) depending on participants' allergies

Group II: PlaceboPlacebo Group1 Intervention

Identical appearing placebo for a single dose