Back to resultsPVP Compared to TURP for the Treatment of Benign Hyperplasia of the Prostate (PVP)
Primary Purpose
Benign Prostatic Hyperplasia
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
GreenLight HPS (TM)laser system [Photoselective Vaporization of the prostate (PVP)]
Transurethral resection of the prostate
Sponsored by
About this trial
This is an interventional treatment trial for Benign Prostatic Hyperplasia focused on measuring Benign hyperplasia of the prostate
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
Sites / Locations
- McMaster Institute of Urology at St. Joseph's Healthcare Hamilton
- Trillium Health Centre
- The Scarborough Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PVP
TURP
Arm Description
Photoselective vaporization of the prostate.
Transurethral resection of the prostate.
Outcomes
Primary Outcome Measures
The primary outcome is the change in International Prostatic Symptom Score (IPSS).
Secondary Outcome Measures
International Prostatic Symptom Score (IPSS)
Peak or maximum urinary flow rate
Post-void residual volume
Length of operation/procedure
Frequency of blood transfusion
Change in hemoglobin in recovery room
Postoperative serum electrolytes (sodium, creatinine) in recovery room
Duration of catheterization
Occurrence of urethral stricture or bladder neck contracture requiring re-operation
Re-bleed rate requiring hospitalization
Prostate-specific antigen (PSA) value
Rate of re-operation
Rate of re-catheterization
Rate of sexual dysfunction (SHIM) and/or retrograde ejaculation (specific question)
Use of medications for the treatment of bladder outlet obstruction
Long-term durability of PVP and TURP (i.e. readmission, drug therapy)
IPSS quality of life score (Bother-score)
EQ-5D utility score
Resource utilization: hospital length of stay, OR time, pain medications, follow-up care (e.g. urologist visits, lab tests)
Productivity losses
Full Information
NCT ID
NCT00527371
First Posted
September 6, 2007
Last Updated
February 8, 2018
Sponsor
St. Joseph's Healthcare Hamilton
Collaborators
Ontario Ministry of Health and Long Term Care
1. Study Identification
Unique Protocol Identification Number
NCT00527371
Brief Title
PVP Compared to TURP for the Treatment of Benign Hyperplasia of the Prostate
Acronym
PVP
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Joseph's Healthcare Hamilton
Collaborators
Ontario Ministry of Health and Long Term Care
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia
Keywords
Benign hyperplasia of the prostate
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
164 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PVP
Arm Type
Experimental
Arm Description
Photoselective vaporization of the prostate.
Arm Title
TURP
Arm Type
Active Comparator
Arm Description
Transurethral resection of the prostate.
Intervention Type
Device
Intervention Name(s)
GreenLight HPS (TM)laser system [Photoselective Vaporization of the prostate (PVP)]
Other Intervention Name(s)
PVP
Intervention Description
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
Procedure
Intervention Name(s)
Transurethral resection of the prostate
Other Intervention Name(s)
TURP
Intervention Description
Transurethral resection of the prostate will be performed with a continuous flow resectoscope and unipolar cautery using a standard technique.
Primary Outcome Measure Information:
Title
The primary outcome is the change in International Prostatic Symptom Score (IPSS).
Time Frame
6-months after surgery versus baseline.
Secondary Outcome Measure Information:
Title
International Prostatic Symptom Score (IPSS)
Time Frame
1, 3, 12 and 24 months post procedure
Title
Peak or maximum urinary flow rate
Time Frame
1, 3 and 6 months post surgery
Title
Post-void residual volume
Time Frame
1, 3, 6 month post procedure
Title
Length of operation/procedure
Time Frame
During procedure
Title
Frequency of blood transfusion
Time Frame
During procedure
Title
Change in hemoglobin in recovery room
Time Frame
Following procedure
Title
Postoperative serum electrolytes (sodium, creatinine) in recovery room
Time Frame
Following procedure
Title
Duration of catheterization
Time Frame
10 days after procedure
Title
Occurrence of urethral stricture or bladder neck contracture requiring re-operation
Time Frame
up to 2 years after the procedure
Title
Re-bleed rate requiring hospitalization
Time Frame
1 month after procedure
Title
Prostate-specific antigen (PSA) value
Time Frame
3 months follow-up
Title
Rate of re-operation
Time Frame
At 1, 6, 12 and 24 months following intervention
Title
Rate of re-catheterization
Time Frame
1, 6, 12 and 24 months following intervention
Title
Rate of sexual dysfunction (SHIM) and/or retrograde ejaculation (specific question)
Time Frame
Pre-op, 1, 3, 6 months
Title
Use of medications for the treatment of bladder outlet obstruction
Time Frame
1, 3 and 6 months after intervention
Title
Long-term durability of PVP and TURP (i.e. readmission, drug therapy)
Time Frame
At 12 and 24 months after intervention
Title
IPSS quality of life score (Bother-score)
Time Frame
Pre-op, 1, 3, 6, 12 and 24 months
Title
EQ-5D utility score
Time Frame
Pre-op, 1, 3, 6, 12 and 24 months
Title
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
Title
Productivity losses
Time Frame
Pre-op, 1, 3, 6, 12 and 24 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
41 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Eric Tarride, PhD
Organizational Affiliation
Program for Assessment of Technology in Health, St. Joseph's Healthcare/McMaster University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Gary McIsaac, MD
Organizational Affiliation
Trillium Health Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Edward Woods, MD
Organizational Affiliation
The Scarborough Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paul Whelan, MD
Organizational Affiliation
McMaster Institute of Urology at St. Joseph's Healthcare Hamilton
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster Institute of Urology at St. Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
Trillium Health Centre
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5B 1B8
Country
Canada
Facility Name
The Scarborough Hospital
City
Scarborough
State/Province
Ontario
ZIP/Postal Code
M1P 2T7
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
24319513
Citation
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.
Results Reference
result
PubMed Identifier
24019857
Citation
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.
Results Reference
result
Learn more about this trial
PVP Compared to TURP for the Treatment of Benign Hyperplasia of the Prostate
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