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

NCT ID: NCT00527371

Last Updated: 2018-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 164 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2013-10-31

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.

Detailed Description

Following a review of treatments for benign prostatic hyperplasia (BPH) by the Medical Advisory Secretariat (MAS) of the Ontario Ministry of Health and Long-Term Care (MOHLTC), the Ontario Health Technology Advisory Committee (OHTAC) recommended that "a registry study be conducted to establish longer term effectiveness and complication rates for PVP given the likelihood of increasing diffusion of this technology". Since then, the Medical Devices Bureau of the Therapeutic Products Directorate, Health Canada, has licensed in April 30, 2007, a 120W-KTP laser system (Greenlight HPS (TM)) for sale in Canada. As several new 120W systems will be operating in Ontario in the coming months, there is an urgent need to evaluate the effectiveness, cost-effectiveness and durability of 120W PVP compared to conventional TURP in the treatment of patients with BPH.

Conditions

Benign Prostatic Hyperplasia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PVP

Photoselective vaporization of the prostate.

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

TURP

Transurethral resection of the prostate.

Group Type: ACTIVE_COMPARATOR

Transurethral resection of the prostate

Intervention Type: PROCEDURE

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

Interventions

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

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.

Intervention Type: DEVICE

Transurethral resection of the prostate

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

Intervention Type: PROCEDURE

Other Intervention Names

PVP; TURP

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)
• Bilateral hydronephrosis on renal ultrasound
• Urethral strictures or a residual volume >400 ml
• Immunocompromised
• Previous TURP

• Minimum Eligible Age: 41 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Ontario Ministry of Health and Long Term Care

OTHER_GOV

Sponsor Role: collaborator

St. Joseph's Healthcare Hamilton

OTHER

Sponsor Role: lead

Responsible Party

Jean-Eric Tarride

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jean-Eric Tarride, PhD

Role: STUDY_CHAIR

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

Gary McIsaac, MD

Role: PRINCIPAL_INVESTIGATOR

Trillium Health Centre

Edward Woods, MD

Role: PRINCIPAL_INVESTIGATOR

The Scarborough Hospital

Paul Whelan, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Hamilton, Ontario, Canada

Trillium Health Centre

Mississauga, Ontario, Canada

The Scarborough Hospital

Scarborough Village, Ontario, Canada

Countries

Canada

References

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.

Reference Type: RESULT

PMID: 24319513 (View on PubMed)

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.

Reference Type: RESULT

PMID: 24019857 (View on PubMed)

Other Identifiers

HTA 010-0706-01

Identifier Type: -

Identifier Source: org_study_id