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

NCT04529369 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2020-08-27

No results posted yet for this study

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.

Conditions

  • Benign Prostatic Hyperplasia

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

Sponsors & Collaborators

  • Jewish General Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-31
Primary Completion
2025-10-31
Completion
2030-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04529369 on ClinicalTrials.gov