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NCT07501065 · ClinicalTrials.gov registry record · Phase 4

Prophylactic Antibiotics for Outpatient Urethral Bulking

A Phase 4 study, sponsored by University of Miami.

Not yet
Registry status
Phase 4
Development phase
150
Enrollment target

NCT07501065: Clinical Trial Phase 4 study, sponsored by University of Miami.

NCT07501065 is a Phase 4 study that has not yet begun recruiting, run by University of Miami. The registered enrollment target is 150 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07501065, a Phase 4 study, has not yet begun recruiting, sponsored by University of Miami.

NOT YET RECRUITING
Registry status
Phase 4
Development phase
150 participants
Enrollment target

Study Summary

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).

Primary Outcome

The occurrence of urinary tract infection (UTI) within 6 weeks post-procedure will be compared between patients who receive prophylactic oral antibiotics administered in clinic at the time of urethral bulking and those who do not receive antibiotic prophylaxis. UTI will be defined by clinical diagnosis documented in the medical record, with or without supporting urine culture results.

Interventions

  • DRUG Bactrim (800/160 mg) or Macrobid (100mg)

Trial Details

FieldValue
Enrollment Target 150 participants
Start Date 2026-06
Est. Completion 2028-12
Phase Phase 4
University of Miami

721 total trials

What is known before NCT07501065 opens enrollment

NCT07501065 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (71% lower).

The record links to 0 conditions, and to 1 intervention - of which Bactrim (800/160 mg) or Macrobid (100mg) is the first listed.

NCT07501065 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT07501065 about?

NCT07501065 is a clinical study titled "Prophylactic Antibiotics for Outpatient Urethral Bulking". 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).

What is the current status of trial NCT07501065?

This trial is currently not yet recruiting. It is a Phase 4 study. The enrollment target is 150 participants. The study started on 2026-06. Estimated completion is 2028-12.

What interventions are being tested in trial NCT07501065?

The interventions under investigation include: Bactrim (800/160 mg) or Macrobid (100mg) (DRUG).

Who is sponsoring clinical trial NCT07501065?

This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT07501065's enrollment target sits among peer trials

150 533rd of 2000 higher than 1,436 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07501065, the US trial registry maintained by the National Library of Medicine. NCT07501065 (mid enrollment · none site footprint · not yet recruiting) retrieved and formatted by PlainTrial, see methodology.