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Could BOTOX shots in multiple prostate zones ease urinary symptoms?

NCT ID NCT07645456

Disease control Sponsor: Benha University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 compares two ways of injecting BOTOX into the prostate for men with benign prostatic hyperplasia (BPH) who still have bothersome urinary symptoms despite medication. One group receives BOTOX only in the prostate gland, while the other gets injections in the prostate, bladder neck, and urethra. The goal is to see if the broader approach better improves urine flow and reduces symptoms over six months.

What this could mean

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

Active substance
Botulinum Toxin Type A (BOTOX)
What this could lead to
If successful, this combined injection approach could offer a less invasive, drug-free option for men with enlarged prostate who have not responded to standard medications.
What could go wrong
This is an early-phase study with only 60 participants, so results may not apply to all patients. BOTOX injections can cause temporary side effects like pain or urinary tract 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 1

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

Participants

60 people

The number who actually took part.

Started

Oct 2025

Finished

Apr 2026

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

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: Male patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) Moderate symptoms, defined as International Prostate Symptom Score (IPSS) \> 12 Maximum urinary flow rate (Qmax) \< 15 mL/second Prostate volume between 30 and 60 grams Persistent symptoms after at least 6 months of medical therapy for BPH Ability to provide informed consent Exclusion Criteria: story of chronic bladder catheterization Compromised cardiopulmonary status Contraindications to botulinum toxin type A (BoNT-A) Current urinary tract infection Neurogenic voiding dysfunction Post-void residual (PVR) \> 250 mL History of previous prostatic surgery Prostatitis Urethral strictur

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Conditions

The condition(s) this trial relates to.

benign prostatic hyperplasia Lower Urinary Tract Symptoms

As listed by the trial registrant

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

Benign prostatic hyperplasia

Contacts and locations

Locations

  • Benha University Hospitals

    Banhā, Qalyubia Governorate, Egypt

More trials for these conditions

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