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Could one botox shot replace ten for bladder control?

NCT ID NCT05308979

Symptom relief Sponsor: University of California, Irvine 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tested whether giving Botox in one injection site works as well as ten sites for women with overactive bladder or urge incontinence. 116 women were randomly assigned to receive 100 units of Botox in either one or ten spots in the bladder. Researchers measured symptom severity and quality of life using questionnaires before and after treatment.

What this could mean

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

Active substance
Botox (onabotulinumtoxinA)
What this could lead to
If successful, this could show that a single injection works as well as ten, making the procedure simpler and less uncomfortable.
What could go wrong
This is a small, completed Phase 4 trial with only 116 women. Results may not apply to men or people with other bladder conditions. Botox can cause temporary urinary retention or infection.

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

116 people

The number who actually took part.

Started

May 2022

Finished

Mar 2024

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

Accepted

You do not need to have the condition being studied to take part.

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 * 18 years old or greater * Diagnosis of overactive bladder (urinary urgency or frequency, OAB) or urinary urgency incontinence (UUI) Exclusion Criteria: * Have a diagnosis of neurogenic bladder * Received intravesical botox injections within prior 6 months * Current treatment with either: SNM, PTNS, or OAB medications - need wash out as below * SNM - turn device off for at least 2 weeks prior to procedure, off during 3-month follow up window * PTNS - no treatments within 2 weeks of start, none during 3-month post-procedure follow up window * OAB meds - 2 week wash out period prior to injection, none during 3-month post-procedure follow up window * Currently pregnant or trying to get pregnant * Contraindications to Botox® - hypersensitivity to Botox®, inability to self-catheterize/refusal to have indwelling catheter * Have a UTI (can enroll after treatment) * Have urinary retention (PVR\>150cc on two occasions) * Do not speak English or Spanish

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Conditions

The condition(s) this trial relates to.

overactive bladder Urinary Incontinence, Urge

As listed by the trial registrant

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

Overactive bladder Overactive bladder syndrome Urge incontinence Urinary frequency Urinary incontinence, urge Urinary urge incontinence Urinary urgency

Contacts and locations

Locations

  • University of California Irvine Medical Center

    Orange, California, 92868, United States

More trials for these conditions

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