Botox shot during prostate op eases overactive bladder

NCT ID NCT07554989

Disease control Sponsor: Taksim Egitim ve Arastirma Hastanesi Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at 70 men with an enlarged prostate and overactive bladder symptoms. Some received a Botox injection into the prostate during surgery, while others took standard medication after surgery. The Botox group showed better symptom scores at 12 weeks, suggesting a potential benefit. However, the study is small and retrospective, so more research is needed.

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-A (Botox) injection into the prostate
What this could lead to: If successful, this could offer a more effective one-time treatment for overactive bladder symptoms in men undergoing prostate surgery, reducing the need for long-term medication.
What could go wrong: This is a small retrospective study (70 patients) with no randomization, so results may not apply to everyone. The injection adds a procedure with potential risks like pain or infection, and long-term benefits beyond 12 weeks are unknown.

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Study facts

What this study's own registry entry says, in plain language.

Participants

About 70 people

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

Started

Apr 2026

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

"The study population consists of male patients who were treated at Taksim Egitim Ve Arastırma Hastanesi Urology Department. The cohort includes patients who underwent endoscopic prostate surgery for Benign Prostatic Hyperplasia (BPH) and had documented preoperative symptoms of Overactive Bladder (OAB). Data were retrospectively collected from the electronic medical records and patient charts of individuals treated between \[2024\] and \[2027\]."

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: * Male patients aged 40 years and older who were diagnosed with benign prostatic hyperplasia and underwent transurethral resection of the prostate (TURP) or a similar endoscopic prostate surgery were included in the study Exclusion Criteria: * Neurological Pathologies: * Diagnosis of neurogenic bladder. * History of Multiple Sclerosis, Parkinson's disease, or cerebrovascular accident (CVA). * Spinal cord injury or any other conditions leading to neurogenic bladder dysfunction. Metabolic and Systemic Diseases: * Diabetes Mellitus with associated neuropathy. * Severe renal impairment (eGFR \<30 ml/min/1.73 m²). * Severe hepatic impairment (Child-Pugh C). * Moderate hepatic impairment (Child-Pugh B) or severe renal impairment in patients using strong CYP3A inhibitors. Urinary System Related Pathologies: * Previous treatment with intravesical BoNT-A or Mirabegron. * Active urinary tract infection (confirmed by positive urine culture). * Presence of bladder tumor, bladder stones, or bladder diverticulum. * History of pelvic radiotherapy. * Urethral stricture or conditions carrying a risk of re-obstruction. Cardiovascular Risks (Contraindications for Mirabegron and Anticholinergics): * Uncontrolled hypertension (≥180/110 mmHg). * Severe cardiac arrhythmia or heart failure (NYHA Class III-IV). Other Exclusion Criteria: * Patients planning to receive other overactive bladder (OAB) treatments during the study period. * Incomplete follow-up data or missing medical records.

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Conditions

The condition(s) this trial relates to.

benign prostatic hyperplasia bladder neck obstruction overactive bladder

As listed by the trial registrant

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

Bladder outlet obstruction Botulinium toxin-A Prostatic hyperplasia, benign Urinary bladder, overactive

Botox shot during prostate op eases overactive bladder

What the study statuses mean