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Recruiting NCT06839768

Safety and Efficacy of MILEP Versus Standard EEP

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Trial Parameters

Condition Benign Prostate Hypertrophy(BPH)
Sponsor Sechenov University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 340
Sex MALE
Min Age 18 Years
Max Age 85 Years
Start Date 2024-03-14
Completion 2025-03
Interventions
Standard endoscopic enucleation of the prostate (EEP)MiLEP

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Brief Summary

Endoscopic enucleation of the prostate (EEP) is a standard treatment for benign prostatic hyperplasia (BPH), with modifications such as MiLEP that utilizes smaller instruments. The reduced resectoscope diameter in MiLEP may help decrease rates of stress urinary incontinence (SUI) and urethral strictures. Objective: to compare the efficacy and safety of MiLEP and standard EEP with a thulium fiber laser (TFL).

Eligibility Criteria

Inclusion Criteria: LUTS presence, proven by: 1. IPSS questionnaire (Score \>20); 2. OR uroflowmetry result (Qmax \<10 ml/s); Exclusion Criteria: * Prostate volume \> 120 cc * Prostate cancer on pathology; * Urethral strictures; * Bladder calculi; * Prior prostate surgery; * Neurogenic bladder dysfunction.

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