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Could targeted botox ease chronic pelvic pain? new trial aims to find out

NCT ID NCT06796985

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This early-stage study is testing whether using a special muscle-mapping device to guide Botox injections can better relieve chronic pelvic floor pain in women compared to the standard injection method. Researchers will enroll 30 women with long-term pelvic pain and give them two rounds of Botox injections. The goal is to see if the precision-guided approach reduces muscle tightness and pain more effectively.

What this could mean

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

Active substance
botulinum neurotoxin (Botox)
What this could lead to
If this works, it could offer a more effective, targeted way to use Botox for chronic pelvic pain, potentially improving relief for many women.
What could go wrong
This is a very small, early-phase trial (30 people) testing a new guidance method. It may not show a clear benefit, and results may not apply to everyone. Botox injections also carry risks like temporary muscle weakness or pain at the injection site.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 30 people

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

Started

Feb 2025

Expected to finish

Mar 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 to 75 years

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. Females between 18 and 75 years of age 2. Clinical diagnosis of chronic pelvic pain 3. Complaints of pain, pressure, or discomfort in the bladder and/or pelvic area for the past 6 months or more, associated with lower urinary tract symptoms (such as frequency of urination), in the absence of other explanation of the symptoms (e.g., UTI) \* 4. Myofascial pain diagnosed with palpable bands or nodules of contracted muscle fibers 5. Pelvic muscle tenderness by assessment of pelvic floor muscles on digital pelvic examination 6. No botulinum neurotoxin pelvic floor muscle injection treatment within 6 months prior to recruitment 7. Able to provide informed consent Exclusion Criteria: 1. Males 2. Women \< 18 and \> 76 years of age 3. History of pelvic malignancy and sexual transmitted diseases that is currently not in remission 4. Bleeding disorder such as coagulopathy 5. Hypersensitivity to botulinum neurotoxin 6. Received botulinum neurotoxin pelvic floor muscle injection within 6 months prior to recruitment 7. History of neurological disorders, such as spinal cord injury, multiple sclerosis, amyotrophic lateral sclerosis or myasthenia gravis 8. Pregnancy, breast feeding or planning to get pregnant within one year after the last botulinum neurotoxin injection.

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Conditions

The condition(s) this trial relates to.

myofascial pain syndrome Pelvic Floor Disorders

As listed by the trial registrant

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

Pelvic floor disorders

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

  • University of Miami

    RECRUITING

    Miami, Florida, 33136, United States

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