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

N/AActive Not RecruitingNCT07554989

Taksim Egitim ve Arastirma Hastanesi70 enrolled

Overview

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.

Study Design and Patient Selection: This prospective, randomized controlled study aims to evaluate the clinical efficacy of intravesical OnabotulinumtoxinA (BoNT-A) injection when performed concurrently with endoscopic prostate surgery (TURP or Laser Enucleation). Patients diagnosed with concomitant Bladder Outlet Obstruction (BOO) and Overactive Bladder (OAB) via preoperative urodynamic studies will be included in the study. Intervention and Procedure: Participants will be randomized into two groups: 1. Intervention Group: Patients will receive intravesical BoNT-A injections (100 Units) into the detrusor muscle (sparing the trigone) during the same anesthesia session as the endoscopic prostate surgery. 2. Control Group: Patients will undergo endoscopic prostate surgery followed by the standard postoperative medical protocol (e.g., anticholinergics or Beta-3 agonists). Data Collection and Follow-up: Baseline clinical data, including International Prostate Symptom Score (IPSS), Overactive Bladder Symptom Score (OABSS), OAB-V8, International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF), and Incontinence Impact Questionnaire-7 (IIQ-7), will be recorded preoperatively. All patients will be followed for 12 weeks postoperatively. The primary objective is to compare the 12th-week clinical outcomes between the BoNT-A group and the standard medical therapy group. Statistical analysis will be performed to determine if simultaneous BoNT-A administration provides a significant advantage in alleviating OAB symptoms and improving quality of life in the early postoperative period.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Urinary Bladder, Overactive

Eligibility

Sex: MALEMin age: 40 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change in Overactive Bladder Symptom Score (OABSS)

A validated questionnaire used to quantify overactive bladder symptoms. Total score ranges from 0 to 15, where higher scores indicate more severe symptoms

Time frame: Baseline (Preoperative) and Postoperative 12th Week

Secondary Outcomes

IPSS Score Change

International Prostate Symptom Score (0-35 points). Higher scores indicate more severe LUTS

Time frame: Baseline and 12th Week