Prophylactic Antibiotics for Outpatient Urethral Bulking

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT07501065
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Stress Urinary Incontinence
  • Urinary Incontinence
  • Urinary Tract Infections

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bactrim (800/160 mg) or Macrobid (100mg) — DRUG
    Participants will receive a single oral dose of either Bactrim (800 mg sulfamethoxazole + 160 mg trimethoprim) or if allergic to sulfonamides, a single oral dose of Macrobid (100 mg nitrofurantoin) at the time of the urethral bulking procedure.

Study Details

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).

Key Dates

Start date
Jun 30, 2026
Status verified
Mar 2026
Primary completion
Jun 30, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Prophylactic Antibiotic Group
    Participants in this group will receive a single oral dose of either Bactrim (800 mg sulfamethoxazole + 160 mg trimethoprim) or if allergic to sulfonamides, a single oral dose of Macrobid (100 mg nitrofurantoin) at the time of standard of care clinic based urethral bulking procedure.
  • No Intervention: No Prophylactic Antibiotic Group
    Participants in this group will not receive prophylactic antibiotics at the time of standard of care clinic based urethral bulking procedure.

Primary Outcome Measure

Incidence of post-procedural urinary tract infection (UTI) within six weeks following urethral bulking procedure [ Time Frame: 6 Weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Desai Sethi Urology InstituteMiamiFlorida33136
Elena Cortizas, MS
[email protected]
(305) 243-3593
Katherine Amin, MD (PRINCIPAL_INVESTIGATOR)
University of Miami Hospitals and ClinicsMiamiFlorida33136
Elena Cortizas, MS
305-243-3593
Katherine Amin, MD (PRINCIPAL_INVESTIGATOR)

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Desai Sethi Urology Institute· Miami, FLUniversity of Miami Hospitals and Clinics· Miami, FL

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