Not yet recruiting NCT07501065
Prophylactic Antibiotics for Outpatient Urethral Bulking
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bactrim (800/160 mg) or Macrobid (100mg).
- Who it may be relevant to
- Registry conditions: Urinary Tract Infections, Stress Urinary Incontinence, Urinary Incontinence. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prophylactic Antibiotics for Outpatient Urethral Bulking: Impact on Post-Procedural Urinary Tract Infection Rates
Overview
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).
Interventions
- Drug Bactrim (800/160 mg) or Macrobid (100mg)
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.
Primary outcome measures
- Incidence of post-procedural urinary tract infection (UTI) within six weeks following urethral bulking procedure [Time frame: 6 Weeks]
Eligibility criteria
Inclusion criteria
- Women ≥ 18 years of age.
- Patients evaluated by a pelvic floor specialist (either urogynecologist or urologist) at the University of Miami with plans to undergo urethral bulking with Bulkamid for stress urinary incontinence or mixed urinary incontinence (stress predominant).
- Negative testing for UTI in pre-procedural work-up (including either negative urine culture or urine dip negative for infection).
- Post-void residual volume of 150 mL or less (measured by either catheterization or bladder scan)
- Fluent in English or Spanish
- Able and willing to provide informed consent
Exclusion criteria
- Contraindications to both oral antibiotics including antibiotic allergies or significant renal disease (GFR <30)
- Patient undergoing additional pelvic organ prolapse procedures or other urologic procedures concomitantly
- Recurrent UTIs, defined as 3 or more UTIs within the past 12 months or 2 UTIs within the past 6 months
- Patients currently taking daily antibiotic prophylaxis for any reason
- Pelvic organ prolapse stage greater than 2
- Patients with immunosuppression due to underlying medical conditions
- Patients who are pregnant
- Recent antibiotic treatment within one week of the procedure
- Unable or unwilling to provide informed consent or complete study procedures
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 2 centers
- Desai Sethi Urology Institute — Miami
- University of Miami Hospitals and Clinics — Miami
Identifiers
NCT: NCT07501065 · 20260233