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Clinical Trials in Turkey / NCT07554989
Active, not recruiting Observational

Comparison of Concurrent Endoscopic Prostate Surgery With Botox-A Injection and Postoperative Medical Therapy in BPH Patients With Overactive Bladder Symptoms

NCT07554989 · tracked via the Priya Life Science Turkey tracker
Phase
Observational
Started
2026-04-01
Last updated
2026-04-28

Condition(s) studied

Urinary Bladder, OveractiveProstatic Hyperplasia, BenignBladder Outlet ObstructionBotulinium Toxin-A

Study summary

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)

Trial sites (1)

FacilityCityRegionStatus
Taksim Egitim Ve Arastirma Hastanesi Istanbul Turkey (Türkiye)

More Taksim Egitim ve Arastirma Hastanesi trials in Turkey

Other trials for the same condition

Official registry record

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.

View NCT07554989 on ClinicalTrials.gov ↗ ← All trials in Turkey