Comparison of Concurrent Endoscopic Prostate Surgery With Botox-A Injection and Postoperative Medical Therapy in BPH Patients With Overactive Bladder Symptoms
Intravesical OnabotulinumtoxinA (BoNT-A) injection performed concurrently with endoscopic prostate surgery provides superior clinical improvement at the 12th postoperative week compared to standard medical therapy in patients with urodynamically confirmed bladder outlet obstruction (BOO) and concomitant overactive bladder (OAB). This superiority is demonstrated through significant improvements in OABSS, OAB-V8, ICIQ-UI SF, IIQ-7, and IPSS scores.
Eligibility
Sex
MALE
Min age
40 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Change in Overactive Bladder Symptom Score (OABSS) — Baseline (Preoperative) and Postoperative 12th Week A validated questionnaire used to quantify overactive bladder symptoms. Total score ranges from 0 to 15, where higher scores indicate more severe symptoms
Trial sites (1)
Facility
City
Region
Status
Taksim Egitim Ve Arastirma Hastanesi
Istanbul
Turkey (Türkiye)
More Taksim Egitim ve Arastirma Hastanesi trials in Turkey
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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