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NOT YET RECRUITING
NCT04529369
NA

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

Sponsor: Jewish General Hospital

View on ClinicalTrials.gov

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.

Official title: Efficacy and Long-term Durability of Middle Lobe Only (MLO) Versus Complete Trans-Urethral Vaporization of the Prostate (PVP), Prospective Cohort Study.

Key Details

Gender

MALE

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

280

Start Date

2020-10

Completion Date

2030-10

Last Updated

2020-08-27

Healthy Volunteers

No

Interventions

PROCEDURE

Middle lobe only Photoselective vaporization of the prostate (PVP)

Middle lobe only Photoselective vaporization of the prostate (PVP) without vaporization of the lateral lobes

PROCEDURE

Complete PVP

Traditional Photoselective vaporization of the prostate PVP