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

Benign Prostatic Hyperplasia Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00527371
• Other study ID #: HTA 010-0706-01
• Status: Completed
• Phase: N/A
• First received: September 6, 2007
• Last updated: February 8, 2018
• Start date: January 2008
• Est. completion date: October 2013

Study information

• Verified date: February 2018
• Source: St. Joseph's Healthcare Hamilton
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: October 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 41 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

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.

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.

Locations

Country	Name	City	State
Canada	McMaster Institute of Urology at St. Joseph's Healthcare Hamilton	Hamilton	Ontario
Canada	Trillium Health Centre	Mississauga	Ontario
Canada	The Scarborough Hospital	Scarborough	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
St. Joseph's Healthcare Hamilton	Ontario Ministry of Health and Long Term Care

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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 Ass — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome is the change in International Prostatic Symptom Score (IPSS).		6-months after surgery versus baseline.
Secondary	International Prostatic Symptom Score (IPSS)		1, 3, 12 and 24 months post procedure
Secondary	Peak or maximum urinary flow rate		1, 3 and 6 months post surgery
Secondary	Post-void residual volume		1, 3, 6 month post procedure
Secondary	Length of operation/procedure		During procedure
Secondary	Frequency of blood transfusion		During procedure
Secondary	Change in hemoglobin in recovery room		Following procedure
Secondary	Postoperative serum electrolytes (sodium, creatinine) in recovery room		Following procedure
Secondary	Duration of catheterization		10 days after procedure
Secondary	Occurrence of urethral stricture or bladder neck contracture requiring re-operation		up to 2 years after the procedure
Secondary	Re-bleed rate requiring hospitalization		1 month after procedure
Secondary	Prostate-specific antigen (PSA) value		3 months follow-up
Secondary	Rate of re-operation		At 1, 6, 12 and 24 months following intervention
Secondary	Rate of re-catheterization		1, 6, 12 and 24 months following intervention
Secondary	Rate of sexual dysfunction (SHIM) and/or retrograde ejaculation (specific question)		Pre-op, 1, 3, 6 months
Secondary	Use of medications for the treatment of bladder outlet obstruction		1, 3 and 6 months after intervention
Secondary	Long-term durability of PVP and TURP (i.e. readmission, drug therapy)		At 12 and 24 months after intervention
Secondary	IPSS quality of life score (Bother-score)		Pre-op, 1, 3, 6, 12 and 24 months
Secondary	EQ-5D utility score		Pre-op, 1, 3, 6, 12 and 24 months
Secondary	Resource utilization: hospital length of stay, OR time, pain medications, follow-up care (e.g. urologist visits, lab tests)		Pre-op, 1, 3, 6, 12 and 24 months
Secondary	Productivity losses		Pre-op, 1, 3, 6, 12 and 24 months