Assessing the Utility of Prophylactic Antibiotics at Time of Urethral Bulking Using Bulkamid

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: f
View:

• Patients evaluated by a pelvic floor specialist (either urogynecologist or urologist) at The Ohio State University with plans to undergo urethral bulking with Bulkamid for stress urinary incontinence or mixed urinary incontinence (stress predominant).

• Negative testing for UTI in pre-operative work-up (including either negative urine culture or urine dip negative for infection).

• Office evaluation with evidence of SUI either with urodynamic studies (UDS) or positive cough stress test (CST).

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

Locations
United States
Ohio
The Ohio State University Wexner Medical Center OB/GYN Female Pelvic Medicine and Reconstructive Surgery
RECRUITING
Columbus
Contact Information
Primary
Susanne Taege, MD
Susanne.Taege@osumc.edu
614-293-4643
Backup
Shirley Dong, MD
Shirley.Dong@osumc.edu
614-293-8045
Time Frame
Start Date: 2025-09-15
Estimated Completion Date: 2027-10-15
Participants
Target number of participants: 138
Treatments
Active_comparator: Bactrim or Macrobid (single dose)
Bactrim (800/160mg) or Macrobid (100 mg) depending on participants' allergies
Placebo_comparator: Placebo
Identical appearing placebo for a single dose
Sponsors
Leads: Ohio State University

This content was sourced from clinicaltrials.gov