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

NCT04529369 | Not Yet Recruiting DMC

• 1 other identifier: MP-05-2021-2448 (MP)
• Study Type: interventional
• Target: 280
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (5)

• Inability to void

  incidence of inability to void that needs surgical intervention after Middle lobe only PVP compared to complete PVP

  3 months

• IPSS

  The difference in international prostate symptoms score (IPSS) pre and post interventions and compare it between groups

  3 months to 5 years

• Qmax

  The difference in Maximal flow rate (Qmax) pre and post interventions and compare it between groups

  3 months to 5 years

• PVR

  The difference in Post void residual pre and post interventions and compare it between groups

  3 months to 5

• MSHQ-EJD

  The difference in Male sexual health questionnaire ejaculatory dysfunction (MSHQ-EjD) pre and post interventions and compare it between groups

  3 months to 5 years

Secondary Outcomes (7)

• Efficaciy of MLO based on prostate size, PSA, IPP and/or lateral lobes adenine

  3 months to 5 years

• additional treatment

  3 months to 5 years

• bleeding

  3 months

• rate of patients with prominent middle lobe who needs MLO PVP

  3 months to 5 years

• Erectile dysfunction MSHQ

  3 months to 5 years

Study Arms (2)

Prominent middle lobe BPH satisfactory channel after MLO PVP

EXPERIMENTAL

Procedure: Middle lobe only Photoselective vaporization of the prostate (PVP)

Prominent middle lobe BPH unsatisfactory channel after MLO PVP

ACTIVE COMPARATOR

Procedure: Complete PVP

Interventions

Middle lobe only Photoselective vaporization of the prostate (PVP) PROCEDURE

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

Prominent middle lobe BPH satisfactory channel after MLO PVP

Complete PVP PROCEDURE

Traditional Photoselective vaporization of the prostate PVP

Prominent middle lobe BPH unsatisfactory channel after MLO PVP

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult males (18-year-old and more)
• Suffering bothersome LUTS or urinary retention secondary to BPH
• Cystoscopic examination documenting the predominant middle lobe prostatic adenoma that is considered to be the primary cause of BOO.

You may not qualify if:

• Patients neurogenic lower urinary tract dysfunction (Neurogenic Bladder)
• Not competent to give consent and/or inability to provide answers to the questionnaire
• Patient who refuse to participate in the study
• Patients without a median lobe
• Patients who have a large prostate (more than 120 g on trans-abdominal ultrasound prostate sizing).
• Patients who have renal impairment secondary to BPH
• Patients with proven or suspicion of prostate cancer based on clinical examination and/or PSA level
• Patients with refractory hematuria secondary to BPH
• Patients with urethral strictures
• Patients with bladder cancer
• Patients with history of pelvic radiotherapy

Sponsors & Collaborators

• Jewish General Hospital: lead

Related Publications (7)

• Nickel JC, Aaron L, Barkin J, Elterman D, Nachabe M, Zorn KC. Canadian Urological Association guideline on male lower urinary tract symptoms/benign prostatic hyperplasia (MLUTS/BPH): 2018 update. Can Urol Assoc J. 2018 Oct;12(10):303-312. doi: 10.5489/cuaj.5616. No abstract available.

  PMID: 30332601 BACKGROUND

• May F, Hartung R. Surgical atlas. Transurethral resection of the prostate. BJU Int. 2006 Oct;98(4):921-34. doi: 10.1111/j.1464-410X.2006.06474.x. No abstract available.

  PMID: 16978302 BACKGROUND

• Zorn KC, Liberman D. GreenLight 180W XPS photovaporization of the prostate: how I do it. Can J Urol. 2011 Oct;18(5):5918-26.

  PMID: 22018158 BACKGROUND

• Luo GC, Foo KT, Kuo T, Tan G. Diagnosis of prostate adenoma and the relationship between the site of prostate adenoma and bladder outlet obstruction. Singapore Med J. 2013 Sep;54(9):482-6. doi: 10.11622/smedj.2013168.

  PMID: 24068054 BACKGROUND

• Gul Z, Chughtai B, Te AE, Thomas D, Kaplan SA. Ejaculatory Preserving Middle Lobe Onl-Transurethral Resection and Vaporization of the Prostate: 12-Year Experience. Urology. 2019 Dec;134:199-202. doi: 10.1016/j.urology.2019.07.042. Epub 2019 Sep 26.

  PMID: 31563537 BACKGROUND

• Cornu JN, Ahyai S, Bachmann A, de la Rosette J, Gilling P, Gratzke C, McVary K, Novara G, Woo H, Madersbacher S. A Systematic Review and Meta-analysis of Functional Outcomes and Complications Following Transurethral Procedures for Lower Urinary Tract Symptoms Resulting from Benign Prostatic Obstruction: An Update. Eur Urol. 2015 Jun;67(6):1066-1096. doi: 10.1016/j.eururo.2014.06.017. Epub 2014 Jun 25.

  PMID: 24972732 BACKGROUND

• Rassweiler J, Teber D, Kuntz R, Hofmann R. Complications of transurethral resection of the prostate (TURP)--incidence, management, and prevention. Eur Urol. 2006 Nov;50(5):969-79; discussion 980. doi: 10.1016/j.eururo.2005.12.042. Epub 2006 Jan 30.

  PMID: 16469429 BACKGROUND

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery (Urology)

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: August 27, 2020
• Study Start: October 1, 2020
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2030
• Last Updated: August 27, 2020

Record last verified: 2020-08