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One pill before a bladder procedure might slash infection risk

NCT ID NCT07501065

Prevention Sponsor: University of Miami Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 2 times

Summary

This study looks at whether giving women a single dose of antibiotics right before a clinic-based urethral bulking procedure (for stress incontinence) can lower their chance of getting a urinary tract infection afterward. About 150 women will be split into two groups: one gets the antibiotic, the other does not. Researchers will track infections for six weeks after the procedure.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Bactrim (sulfamethoxazole/trimethoprim) or Macrobid (nitrofurantoin)
What this could lead to
If it works, this could provide a simple way to reduce urinary tract infections after a common incontinence procedure.
What could go wrong
This is a small, early-phase study with only 150 participants, so results may not apply to everyone. Antibiotics can also cause side effects or contribute to antibiotic resistance.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 (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 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 that also involve insertion \[KB2.1\]of a foreign object * 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 * 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

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Conditions

The condition(s) this trial relates to.

female stress incontinence Urinary Incontinence Urinary Incontinence, Stress urinary tract infection prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Stress urinary incontinence Urinary incontinence Urinary tract infections

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Desai Sethi Urology Institute

    RECRUITING

    Miami, Florida, 33136, United States

  • University of Miami Hospitals and Clinics

    RECRUITING

    Miami, Florida, 33136, United States

More trials for these conditions

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