Clinical Trial

Middle Lobe Only Laser Vaporization or Total Prostate Vaporization of the Prostate, Prospective Cohort Study

Not Yet Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated August 27, 2020 (before its estimated October 2025 completion). Its status may not reflect the trial's current state.
Summary
The investigator aims to prospectively investigate the efficacy and durability of the middle lobe only versus traditional complete photoselective greenlight vaporization of the prostate in patients with prominent middle lobe. The investigator will select patients based on pre-op cystoscopy if patients have a prominent middle lobe to participate in this study. Researches will start to vaporize only the middle lobe then, at the end of this step, The investigator will look at the verumontanum into the prostatic fossa and determine if the patient is having adequate opened prostatic fossa or not. Patients with unsatisfactory opened fossa will have a complete PVP of lateral lobes, while patients with a satisfactory channel will not receive a complete PVP. Primary objectives of the study are to look into pre and post-operative uroflowmetry and post-void residual, International prostate symptoms scores, need of catheterization, and need for secondary interventions over five then ten years. Secondary objectives are to look into erectile and ejaculatory status using the Male Sexual Health Questionnaire (MSHQ) and MSHQ-EjD Short Form for Assessing EjD. Researchers will follow the patients at three months, six months, one year then yearly for five years then an extension to up to 10 years.
Trial Details
NCT Number NCT04529369
Lead Sponsor Jewish General Hospital
Conditions Benign Prostatic Hyperplasia
Enrollment 280 participants
Start Date 2020-10
Primary Completion 2025-10 (estimated)
Study Completion 2030-10 (estimated)
Updated on ClinicalTrials.gov 2020-08-27