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Botox during prostate surgery: a promising combo that never got tested

NCT ID NCT05393921

Symptom relief Sponsor: University Hospitals Cleveland Medical Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 26, 2026 · Updated 2 times

Summary

This study aimed to see if giving Botox injections into the bladder at the same time as HoLEP prostate surgery could improve urinary symptoms in men with an enlarged prostate and overactive bladder. The plan was to compare symptom scores and urine flow between men who got both treatments and those who had surgery alone. However, the study was withdrawn before any participants were enrolled, so no conclusions can be drawn.

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) injection into the bladder
What this could lead to
If it worked, this approach could offer faster and more complete relief from urinary symptoms after prostate surgery, reducing the need for a second procedure.
What could go wrong
The study was withdrawn before enrolling anyone, so no results are available. Combining treatments may increase risks like infection or urinary retention without clear benefit.

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.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jul 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

40 years and older

Sex

Male 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: * Males age \> 40 * Patients diagnosed with Benign Prostatic Hyperplasia (BPH) and referred for HoLEP surgery * Lower urinary tract symptoms (LUTS) of Overactive Bladder Syndrome (OABS) frequency - urgency - urge incontinence episodes - dysuria - nocturia and eligible for bladder botox injections * International Prostate Symptom Score (IPSS) ≥ 17 * Overactive Bladder Symptom Score (OABSS) ≥ 7 * Participants have failed, are intolerant, or bad candidates for anticholinergic medication treatment for OAB Exclusion Criteria: * History of bladder/prostate cancer * History of pelvic radiotherapy * History of neurological diseases * Presence of active Urinary Tract Infection (UTI) * Previous Bladder Outlet Procedure (Transurethral resection of prostate (TURP) Transurethral Incision of Prostate (TUIP) - UroLift, etc..) * History of adverse reaction to Botox injections * Post-void residual (PVR) greater than 300 ml * History of clean intermittent catheterization * Patients unable to stop anticoagulation of antiplatelet inhibitors 3 days prior to procedure

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Conditions

The condition(s) this trial relates to.

benign prostatic hyperplasia overactive bladder

As listed by the trial registrant

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

Benign prostatic hyperplasia Overactive bladder

Contacts and locations

Locations

  • UH Brainard Medical Bldg

    Lyndhurst, Ohio, 44124, United States

  • UH Regional Hospitals - Richmond Campus

    Richmond Heights, Ohio, 44143, United States

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

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