Prophylactic Antibiotics for Urinary Incontinence

Overseen By Shirley Dong, 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).

Research Team

Susanne Taege, MD

Principal Investigator

Ohio State University

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 have been diagnosed with stress urinary incontinence.

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

Post-void residual volume of 150 mL or less (measured by either catheterization or bladder scan)

Exclusion Criteria

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

Patients with immunosuppression due to underlying medical conditions

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

Treatment Details

Interventions

• Bactrim (Anti-bacterial)
• Macrobid (Anti-bacterial)

Trial Overview 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.

Participant Groups

Group I: Bactrim or Macrobid (single dose) Active Control 1 Intervention

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

Group II: Placebo Placebo Group 1 Intervention

Identical appearing placebo for a single dose

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+