Comparative evaluation of the surgical outcome Thulium laser enucleation of the prostate

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2015
INTERVENTION: 1. Randomization arm 1: Thulium laser enucleation (ThuLEP) 2. Randomization arm 2: Transurethral Resection of the Prostate (TURP) Prospective data collection of consecutive cases: Open Simple Prostatectomy (OSP) CONDITION: Benign prostatic hyperplasia, benign bladder outlet obstruction, urology ; Cancer PRIMARY OUTCOME: 1. Symptoms (International Prostate Symptom Score, I‐PSS), measured pre‐operatively, at 1 month, at 3 months and at 12 months; 2. Maximum flow rate: Urodynamic evaluation, measured pre‐operatively and at 3 months; 3. Time for catheter removal; 4. Erectile function (International Index of Erectile Function Questionnaire, IIEF) at 1 month, 3 months and 12 months; 5. Complications during first month after surgery and at 12 months SECONDARY OUTCOME: Treatment cost INCLUSION CRITERIA: Candidates for surgical treatment of Benign Prostatoc Hyperplasia (BPH): 1. Prostate volume >60ml 2. Qmax <15ml/s 3. Post‐void residual (PVR) <150ml 4. Insufficient conservative or pharmacological treatment of BPH 5. Urodynamic confirmation of bladder outlet obstruction
Epistemonikos ID: 86331bf93b33de3590bfc03d737dbe61d71b4c11
First added on: Aug 23, 2024