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Prophylactic Antibiotics for Outpatient Urethral Bulking

StatusRecruiting
PhasePhase 4
Started2026-08
View on ClinicalTrials.gov ↗

Amendment history

2026-08-18
notable
Study Status, Arms and Interventions, Eligibility, Contacts/Locations v1
Recruitment opened
Start date2026-06→2026-08
InterventionsBactrim (800/160 mg) or Macrobid (100mg) (Drug)→Bactrim (800/160 mg), Keflex (500 mg), Cipro (250 mg), or Macrobid (100mg) (Drug)
Eligibility criteria+151 characters
[...] ominant). Negative testing for UTI in pre-procedural work-up, (including either negative urine culture or urine dip negative for infection (infection is defined as the presence of nitrites and/or pyuria with >1+ leukocyte esterase on dipstick or >5 WBC/HPF). Post-void residual volume of 150 mL or less (measured by either catheterization or bladder scan) before the procedure Fluent in English or Spanish Able and willing to provide in [...] olapse procedures or other urologic procedures concomitantly that also involve insertion [KB2.1]of a foreign object Recurrent UTIs, defined as 3 or more UTIs within [...] [...]
Study sitesdetails revised at 2 of 2 sites
2026-03-24
minor
Original filing
The purpose of this study is to evaluate whether taking prophylactic (preventative) antibiotics at the time of standard of care clinic-based urethral bulking reduces the risk of post-procedural urinary tract infection (UTI).
Trial Details
NCT Number NCT07501065
Lead Sponsor University of Miami
Conditions Urinary Tract Infections, Stress Urinary Incontinence, Urinary Incontinence
Enrollment 150 participants
Start Date 2026-08
Primary Completion 2028-06 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-08-20