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Botox shot may help stop leaky bladder – early study hopes

NCT ID NCT04984317

Disease control Sponsor: Northwell Health 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This early-phase study tests whether a one-time injection of Botox into the bladder muscle can reduce urine leakage in women with stress urinary incontinence. Twenty women who have not improved with other treatments will receive the injection and be monitored for changes in leakage and side effects. The trial is currently suspended, and results are not yet available.

What this could mean

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

Active substance
onabotulinumtoxin A (Botox)
What this could lead to
If it works, this could offer a new, non-surgical option to reduce urine leakage in women with stress incontinence.
What could go wrong
This is a very early, small trial that is currently suspended. It may not show clear benefit, and risks include infection, urinary retention, and pelvic pain.

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 20 people

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

Started

Feb 2022

Expected to finish

Aug 2027

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

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: * Must be female sex and at least 18 years of age. * Must be willing and able to complete all procedures and follow-up visits indicated in the protocol. * Must have confirmed stress urinary incontinence (SUI) through urodynamic studies. * Must have failed two non-invasive incontinence therapies (such as behavior modification, Kegel exercises, etc) for \> 3 months. Exclusion Criteria: * Currently suffering from active urogenital infection. * Has incontinence due to neurogenic causes (such as multiple sclerosis, cerebrovascular accident, spinal cord/brain injury, Parkinson Disease, detrusor-external sphincter dyssynergia, or similar conditions). * Having concomitant pelvic floor or cystoscopic procedure. * Has had prior surgical SUI treatment. * Has had prior radiation therapy or brachy therapy. * Has an atonic bladder or post-void residual (PVR) above 100cc on two or more occasions. * Is pregnant or planning to become pregnant during the study duration. * Has a contraindication to therapeutic BOTOX injections or cystoscopic procedures. * Is enrolled in a concurrent clinical trial of any treatment (drug or device) that could affect urinary continence or bladder function without the sponsor's approval.

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Conditions

The condition(s) this trial relates to.

female stress incontinence Urinary Incontinence Urinary Incontinence, Stress

As listed by the trial registrant

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

Stress urinary incontinence

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

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Weill Cornell Medicine

    New York, New York, 10065, United States

More trials for these conditions

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