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Could a Take-Home antibiotic prescription cut unnecessary ER visits after bladder botox?

NCT ID NCT07648290

Symptom relief Sponsor: The Cleveland Clinic 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 04, 2026 · Updated 2 times

Summary

This study tests whether giving patients a standing prescription for antibiotics to use at the first sign of a UTI after Botox for overactive bladder reduces unplanned healthcare visits. 260 women scheduled for Botox will either get the self-start prescription or follow standard triage care. The goal is to see if the self-start approach lowers calls, messages, and emergency visits for urinary symptoms.

What this could mean

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

Active substance
Nitrofurantoin (Macrobid) or alternative antibiotics
What this could lead to
If it works, this could simplify UTI management after Botox for overactive bladder, reducing unnecessary clinic visits.
What could go wrong
This is an early-phase study with no results yet. The self-start approach may not reduce healthcare use and could lead to antibiotic overuse or 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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 260 people

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

Started

Jul 2026

Expected to finish

Mar 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: * Female patients of all races and ethnicities aged 18 years and older. * Diagnosis of Overactive Bladder (OAB) and/or Urge Urinary Incontinence (UUI). * Scheduled to receive intradetrusor onabotulinumtoxinA (Botox®) for symptom management. * Has decision making capacity to provide informed consent and comply with and follow study protocols. * Ability to navigate a computer system independently * Access to MyChart and email account Exclusion Criteria: * Patients who currently perform Clean Intermittent Catheterization (CIC) or have an indwelling catheter. * History of Severe Renal Impairment Cr/Cl - \<60 ml/min 1.73m2 * History of recurrent UTIs (defined as \>3x symptomatic UTIs in 12 months). * Post-Void Residual (PVR) volume \>150 mL. * Active UTI at the time of procedure (procedure cancellation criteria). * Patients currently on prophylactic antibiotics. * Inability to provide informed consent.

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Conditions

The condition(s) this trial relates to.

overactive bladder

As listed by the trial registrant

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

Overactive bladder

How to take part

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

  1. The places running it

    1 site. 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

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

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