Clinical trial NCT00527371: PVP Compared to TURP for the Treatment of Benign Hyperplasia of the Prostate
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
Overall status: COMPLETED
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Keywords: Benign hyperplasia of the prostate
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
Collaborators: name: Ontario Ministry of Health and Long Term Care
First posted: 2007-09-10
Enrollment: 164
Sex: MALE
Minimum age (years): 41
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The primary outcome is the change in International Prostatic Symptom Score (IPSS).
timeFrame: 6-months after surgery versus baseline.
Secondary outcomes:
measure: International Prostatic Symptom Score (IPSS)
timeFrame: 1, 3, 12 and 24 months post procedure
measure: Peak or maximum urinary flow rate
timeFrame: 1, 3 and 6 months post surgery
measure: Post-void residual volume
timeFrame: 1, 3, 6 month post procedure
measure: Length of operation/procedure
timeFrame: During procedure
measure: Frequency of blood transfusion
timeFrame: During procedure
measure: Change in hemoglobin in recovery room
timeFrame: Following procedure
measure: Postoperative serum electrolytes (sodium, creatinine) in recovery room
timeFrame: Following procedure
measure: Duration of catheterization
timeFrame: 10 days after procedure
measure: Occurrence of urethral stricture or bladder neck contracture requiring re-operation
timeFrame: up to 2 years after the procedure
measure: Re-bleed rate requiring hospitalization
timeFrame: 1 month after procedure
measure: Prostate-specific antigen (PSA) value
timeFrame: 3 months follow-up
measure: Rate of re-operation
timeFrame: At 1, 6, 12 and 24 months following intervention
measure: Rate of re-catheterization
timeFrame: 1, 6, 12 and 24 months following intervention
measure: Rate of sexual dysfunction (SHIM) and/or retrograde ejaculation (specific question)
timeFrame: Pre-op, 1, 3, 6 months
measure: Use of medications for the treatment of bladder outlet obstruction
timeFrame: 1, 3 and 6 months after intervention
measure: Long-term durability of PVP and TURP (i.e. readmission, drug therapy)
timeFrame: At 12 and 24 months after intervention
measure: IPSS quality of life score (Bother-score)
timeFrame: Pre-op, 1, 3, 6, 12 and 24 months
measure: EQ-5D utility score
timeFrame: Pre-op, 1, 3, 6, 12 and 24 months
measure: Resource utilization: hospital length of stay, OR time, pain medications, follow-up care (e.g. urologist visits, lab tests)
timeFrame: Pre-op, 1, 3, 6, 12 and 24 months
measure: Productivity losses
timeFrame: Pre-op, 1, 3, 6, 12 and 24 months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster Institute of Urology at St. Joseph's Healthcare Hamilton
state: Ontario
city: Mississauga
country: Canada
facility: Trillium Health Centre
state: Ontario
city: Scarborough
country: Canada
facility: The Scarborough Hospital
state: Ontario
Study officials:
affiliation: Program for Assessment of Technology in Health, St. Joseph's Healthcare/McMaster University
name: Jean-Eric Tarride, PhD
role: STUDY_CHAIR
affiliation: Trillium Health Centre
name: Gary McIsaac, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Scarborough Hospital
name: Edward Woods, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster Institute of Urology at St. Joseph's Healthcare Hamilton
name: Paul Whelan, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.