PVP Compared to TURP for the Treatment of Benign Hyperplasia of the Prostate

NCT00527371 | Completed

• 1 other identifier: HTA 010-0706-01
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 3

Brief Summary

In patients with an enlarged prostate (benign prostatic hyperplasia), is treatment using photoselective vaporization of the prostate (PVP 120 Watt) as effective and cost-effective as the standard treatment of transurethral resection of the prostate (TURP)? A higher-power (120W) laser system has recently been approved by Health Canada for the treatment of an enlarged prostate. This system, which uses laser energy to vaporize the prostate tissue, will be compared with the current standard treatment of transurethral resection of the prostate. This newer generation laser may offer more efficient removal of prostate tissue with fewer complications and may result in clinical and economic benefits compared to the standard treatment. However, there have been no studies comparing the 120W laser with the standard transurethral resection of the prostate. This study will provide currently unavailable information for clinicians and decision makers.

Conditions

Benign Prostatic Hyperplasia

Keywords

Benign hyperplasia of the prostate

Outcome Measures

Primary Outcomes (1)

• The primary outcome is the change in International Prostatic Symptom Score (IPSS).

  6-months after surgery versus baseline.

Secondary Outcomes (20)

• International Prostatic Symptom Score (IPSS)

  1, 3, 12 and 24 months post procedure

• Peak or maximum urinary flow rate

  1, 3 and 6 months post surgery

• Post-void residual volume

  1, 3, 6 month post procedure

• Length of operation/procedure

  During procedure

• Frequency of blood transfusion

  During procedure

Study Arms (2)

PVP

EXPERIMENTAL

Photoselective vaporization of the prostate.

Device: GreenLight HPS (TM)laser system [Photoselective Vaporization of the prostate (PVP)]

TURP

ACTIVE COMPARATOR

Transurethral resection of the prostate.

Procedure: Transurethral resection of the prostate

Interventions

GreenLight HPS (TM)laser system [Photoselective Vaporization of the prostate (PVP)] DEVICE

Photoselective vaporization of the prostate will be performed using the GreenLight HPS (TM)laser system (American Medical Systems), which is a high-power (120W) potassium titanyl phosphate (KTP) laser which was licensed by Health Canada in April 2007.

Also known as: PVP

PVP

Transurethral resection of the prostate PROCEDURE

Transurethral resection of the prostate will be performed with a continuous flow resectoscope and unipolar cautery using a standard technique.

Also known as: TURP

TURP

Eligibility Criteria

• Age: 41 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male over the age of 40
• Diagnosed with symptomatic/obstructive symptoms secondary to BPH requiring surgical intervention as determined by their urologist
• Experienced lower urinary tract symptoms (LUTS) secondary to BPH \> 3 months in duration
• IPSS value of \> 12
• Peak urinary flow \< 15mL/sec on voided volume (minimum of 150 ml)
• Prostate size, as measured by transrectal ultrasonography (TRUS), less than 100cc in volume
• American Society of Anesthesiology (ASA) classification of physical status, class 1-3
• Able to read, understand, and sign the Informed Consent
• Willing and able to comply with all follow-up requirements including multiple follow-up visits

You may not qualify if:

• Transvesically measured post-void residual volume \>400 mL
• Currently in urinary retention
• Chronic urinary retention
• Medications impairing bladder contractibility
• Uncorrectable bleeding disorders or long- term anticoagulation that cannot be stopped
• Recent myocardial infarction or coronary artery stent placement
• Any of the following diseases which appear to involve the bladder: myasthenia gravis, diabetes neuropathy, multiple sclerosis, spinal cord injury or Parkinson disease
• Any patient with idiopathic atonic bladder
• Major pelvic fractures that involved damage to the external urinary sphincter
• Recently completed definitive radiation therapy for prostate cancer
• Active localized or systemic infections; including active urinary tract infection
• Active cystolithiasis, urethral strictures, bladder neck contracture, or acute prostatitis affecting bladder function
• If patient's PSA value \> PSA age-adjusted normal value, patient needs to have a negative biopsy before participating in the study
• Confirmed malignancy of the prostate
• Bladder cancer treated with transurethral resection of bladder cancer (TURBT) within 12 months or any patients treated with Bacillius Calmette-Guerin (BCG)

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead
• Ontario Ministry of Health and Long Term Care: collaborator

Study Sites (3)

McMaster Institute of Urology at St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

Trillium Health Centre

Mississauga, Ontario, L5B 1B8, Canada

Location

The Scarborough Hospital

Scarborough Village, Ontario, M1P 2T7, Canada

Location

Related Publications (2)

• Whelan JP, Bowen JM, Burke N, Woods EA, McIssac GP, Hopkins RB, O'Reilly DJ, Xie F, Sehatzadeh S, Levin L, Mathew SP, Patterson LL, Goeree R, Tarride JE. A prospective trial of GreenLight PVP (HPS120) versus transurethral resection of the prostate in the treatment of lower urinary tract symptoms in Ontario, Canada. Can Urol Assoc J. 2013 Sep-Oct;7(9-10):335-41. doi: 10.5489/cuaj.180.

  PMID: 24319513 RESULT

• Bowen JM, Whelan JP, Hopkins RB, Burke N, Woods EA, McIsaac GP, O'Reilly DJ, Xie F, Sehatzadeh S, Levin L, Mathew SP, Patterson LL, Goeree R, Tarride JE. Photoselective vaporization for the treatment of benign prostatic hyperplasia. Ont Health Technol Assess Ser. 2013 Aug 1;13(2):1-34. eCollection 2013.

  PMID: 24019857 RESULT

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Transurethral Resection of Prostate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Prostatectomy; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Jean-Eric Tarride, PhD

  Program for Assessment of Technology in Health, St. Joseph's Healthcare/McMaster University

  STUDY CHAIR

• Gary McIsaac, MD

  Trillium Health Centre

  PRINCIPAL INVESTIGATOR

• Edward Woods, MD

  The Scarborough Hospital

  PRINCIPAL INVESTIGATOR

• Paul Whelan, MD

  McMaster Institute of Urology at St. Joseph's Healthcare Hamilton

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: September 6, 2007
• First Posted: September 10, 2007
• Study Start: January 1, 2008
• Primary Completion: February 1, 2013
• Study Completion: October 1, 2013
• Last Updated: February 12, 2018

Record last verified: 2018-02

Locations

CA (3)