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Can early botox shots save bladders after spinal cord injury?

NCT ID NCT06793683

Prevention Sponsor: University of Washington 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 09, 2026 · Last updated Sep 10, 2026 · Updated 1 time

Summary

Researchers are testing whether injecting Botox into the bladder wall soon after a spinal cord injury can prevent lasting bladder damage. The study enrolls 10 adults with recent injuries at T6 or higher. Half receive Botox injections and half receive saline sham injections. The team tracks bladder function and side effects over 12 months to see if early treatment helps preserve bladder compliance and long-term health.

What this could mean

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

Active substance
Botox (botulinum toxin A) injected into the bladder wall muscle
What this could lead to
If it works, early bladder Botox could help people with new spinal cord injuries keep their bladders flexible and avoid long-term damage.
What could go wrong
This is a very early, 10-person pilot study. It may not recruit enough people to finish, and the injections carry risks like urinary tract infections, blood in urine, and anesthesia complications.

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 10 people

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

Started

Jul 2024

Expected to finish

Sep 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 to 65 years

Sex

Anyone

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: * Male or female 18-65 years of age at time of SCI. * English speaking * Recent SCI (within 20 weeks of injury). * Documentation of a spinal cord injury at T6 or higher, American Spinal Injury Association Impairment Scale (AIS) level A or B as designated on initial (72 hour) AIS exam. * Ability for subject to comply with the requirements of the study. * Written informed consent obtained from subject. Exclusion Criteria: * Inability to return to research site (Harborview Medical Center) for follow-up studies after initial hospitalization. * Acute (as part of concurrent hospitalization) or history of bladder surgery (urethral or prostate surgery acceptable) or injury. * Inability to provide informed consent. * Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study. * Incarcerated in a detention facility or in police custody. * Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data. * Active medical problems precluding the safe conduct of urodynamics, bladder chemodenervation, bladder biopsy (e.g., evidence of active bladder infection, ruled out by urine culture prior to procedures) * Known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation * Cardiovascular instability

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Conditions

The condition(s) this trial relates to.

autonomic dysreflexia spinal cord injury Urinary Bladder, Neurogenic

As listed by the trial registrant

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

Spinal cord injuries

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

  • Harborview Medical Center

    Seattle, Washington, 98104, United States

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