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

February 8, 2018 updated by: Jean-Eric Tarride, St. Joseph's Healthcare Hamilton

Prospective Controlled Trial Comparing Photoselective Vaporization of the Prostate (PVP-120W) to Transurethral Resection of the Prostate (TURP) for the Treatment of Benign Hyperplasia of the Prostate (BPH)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
164

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • McMaster Institute of Urology at St. Joseph's Healthcare Hamilton
      • Mississauga, Ontario, Canada, L5B 1B8
        • Trillium Health Centre
      • Scarborough, Ontario, Canada, M1P 2T7
        • The Scarborough Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

41 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PVP
Photoselective vaporization of the prostate.
Device: 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.
Other Names:
  • PVP
Active Comparator: TURP
Transurethral resection of the prostate.
Procedure: 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.
Other Names:
  • TURP

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The primary outcome is the change in International Prostatic Symptom Score (IPSS).
Time Frame: 6-months after surgery versus baseline.
6-months after surgery versus baseline.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
International Prostatic Symptom Score (IPSS)
Time Frame: 1, 3, 12 and 24 months post procedure
1, 3, 12 and 24 months post procedure
Peak or maximum urinary flow rate
Time Frame: 1, 3 and 6 months post surgery
1, 3 and 6 months post surgery
Post-void residual volume
Time Frame: 1, 3, 6 month post procedure
1, 3, 6 month post procedure
Length of operation/procedure
Time Frame: During procedure
During procedure
Frequency of blood transfusion
Time Frame: During procedure
During procedure
Change in hemoglobin in recovery room
Time Frame: Following procedure
Following procedure
Postoperative serum electrolytes (sodium, creatinine) in recovery room
Time Frame: Following procedure
Following procedure
Duration of catheterization
Time Frame: 10 days after procedure
10 days after procedure
Occurrence of urethral stricture or bladder neck contracture requiring re-operation
Time Frame: up to 2 years after the procedure
up to 2 years after the procedure
Re-bleed rate requiring hospitalization
Time Frame: 1 month after procedure
1 month after procedure
Prostate-specific antigen (PSA) value
Time Frame: 3 months follow-up
3 months follow-up
Rate of re-operation
Time Frame: At 1, 6, 12 and 24 months following intervention
At 1, 6, 12 and 24 months following intervention
Rate of re-catheterization
Time Frame: 1, 6, 12 and 24 months following intervention
1, 6, 12 and 24 months following intervention
Rate of sexual dysfunction (SHIM) and/or retrograde ejaculation (specific question)
Time Frame: Pre-op, 1, 3, 6 months
Pre-op, 1, 3, 6 months
Use of medications for the treatment of bladder outlet obstruction
Time Frame: 1, 3 and 6 months after intervention
1, 3 and 6 months after intervention
Long-term durability of PVP and TURP (i.e. readmission, drug therapy)
Time Frame: At 12 and 24 months after intervention
At 12 and 24 months after intervention
IPSS quality of life score (Bother-score)
Time Frame: Pre-op, 1, 3, 6, 12 and 24 months
Pre-op, 1, 3, 6, 12 and 24 months
EQ-5D utility score
Time Frame: Pre-op, 1, 3, 6, 12 and 24 months
Pre-op, 1, 3, 6, 12 and 24 months
Resource utilization: hospital length of stay, OR time, pain medications, follow-up care (e.g. urologist visits, lab tests)
Time Frame: Pre-op, 1, 3, 6, 12 and 24 months
Pre-op, 1, 3, 6, 12 and 24 months
Productivity losses
Time Frame: Pre-op, 1, 3, 6, 12 and 24 months
Pre-op, 1, 3, 6, 12 and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
St. Joseph's Healthcare Hamilton

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ontario Ministry of Health and Long Term Care

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Jean-Eric Tarride, PhD, Program for Assessment of Technology in Health, St. Joseph's Healthcare/McMaster University
  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 6, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 10, 2007

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 12, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HTA 010-0706-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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