Bladder Outlet Obstruction, Botulinium Toxin-A, Prostatic Hyperplasia, Benign, Urinary Bladder, Overactive
Conditions
Keywords
BPH, OAB, BONT-A, TUR-P, LUTS
Brief 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.
Detailed description
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.
Interventions
None listed
Sponsors
Taksim Egitim ve Arastirma Hastanesi
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
40 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IPSS Score Change | Baseline and 12th Week | International Prostate Symptom Score (0-35 points). Higher scores indicate more severe LUTS |
Countries
Turkey (Türkiye)
Outcome results
None listed