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Withdrawn study: could adding a pill to botox tame overactive bladder?

NCT ID NCT06438861

Disease control Sponsor: University of Alabama at Birmingham Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study planned to see if adding the daily pill vibegron to standard Botox bladder injections helps women with overactive bladder that hasn't improved with other treatments. Researchers aimed to compare changes in urgent leaks and symptom distress over 12 weeks. However, the trial was withdrawn before any participants were enrolled, so no new information was gathered.

What this could mean

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

Active substance
Vibegron (a daily pill) plus onabotulinumtoxinA (Botox) injections into the bladder
What this could lead to
If it had worked, this could point toward a more effective combination treatment for women with stubborn overactive bladder symptoms.
What could go wrong
The trial was withdrawn before enrolling anyone, so no results are available. Combination therapy for overactive bladder is still experimental and may not prove better than standard care.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Started

Jan 2025

Finished

Dec 2025

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: 1. Women undergoing intradetrusor botulinum injections for refractory OAB 2. Age 18 years old or greater 3. Fluency and literacy in English 4. Capacity to provide consent Exclusion Criteria: 1. Allergy to Vibegron 2. Currently pregnant or planning to become pregnant 3. Breastfeeding 4. Current digoxin use

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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 syndrome

More trials for these conditions

Other studies related to the condition(s) this trial covers.