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Benign Prostatic HyperplasiaPVPNCT00527371

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

A study testing GreenLight HPS (TM)laser system [Photoselective Vaporization of the prostate (PVP)] and Transurethral resection of the prostate in people with Benign Prostatic Hyperplasia, run by St. Joseph's Healthcare Hamilton at 3 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 41 years and older, men only
Conditions the study is for
Benign Prostatic Hyperplasia
What is being tested?
GreenLight HPS (TM)laser system [Photoselective Vaporization of the prostate (PVP)] and Transurethral resection of the prostate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
164 participants
Where
3 sitesCanada
Study dates
Jan 2008to Oct 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 41 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

3 sites in 1 country.

Canada3 sites

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

    Hamilton, Ontario, L8N 4A6

  • Trillium Health Centre

    Mississauga, Ontario, L5B 1B8

  • The Scarborough Hospital

    Scarborough Village, Ontario, M1P 2T7

Other trials in Canada

About this study

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)

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.

Read the 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.

Being tested
GreenLight HPS (TM)laser system [Photoselective Vaporization of the prostate (PVP)], Transurethral resection of the prostate
Keywords
Benign hyperplasia of the prostate
Medical subject headings
Prostatic Hyperplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called 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.

  • Transurethral resection of the prostateProcedure or surgery

    Also called TURP

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

Study groups in NCT00527371
Study groupRoleWhat they receive
PVPExperimentalPhotoselective vaporization of the prostate.
Receives: Device: GreenLight HPS (TM)laser system [Photoselective Vaporization of the prostate (PVP)]
TURPActive comparatorTransurethral resection of the prostate.
Receives: Procedure: Transurethral resection of the prostate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary outcome is the change in International Prostatic Symptom Score (IPSS).

    Measured: 6-months after surgery versus baseline.

Secondary outcomes (20)

  1. International Prostatic Symptom Score (IPSS)

    Measured: 1, 3, 12 and 24 months post procedure

  2. Peak or maximum urinary flow rate

    Measured: 1, 3 and 6 months post surgery

  3. Post-void residual volume

    Measured: 1, 3, 6 month post procedure

  4. Length of operation/procedure

    Measured: During procedure

  5. Frequency of blood transfusion

    Measured: During procedure

  6. Change in hemoglobin in recovery room

    Measured: Following procedure

  7. Postoperative serum electrolytes (sodium, creatinine) in recovery room

    Measured: Following procedure

  8. Duration of catheterization

    Measured: 10 days after procedure

  9. Occurrence of urethral stricture or bladder neck contracture requiring re-operation

    Measured: up to 2 years after the procedure

  10. Re-bleed rate requiring hospitalization

    Measured: 1 month after procedure

  11. Prostate-specific antigen (PSA) value

    Measured: 3 months follow-up

  12. Rate of re-operation

    Measured: At 1, 6, 12 and 24 months following intervention

  13. Rate of re-catheterization

    Measured: 1, 6, 12 and 24 months following intervention

  14. Rate of sexual dysfunction (SHIM) and/or retrograde ejaculation (specific question)

    Measured: Pre-op, 1, 3, 6 months

  15. Use of medications for the treatment of bladder outlet obstruction

    Measured: 1, 3 and 6 months after intervention

  16. Long-term durability of PVP and TURP (i.e. readmission, drug therapy)

    Measured: At 12 and 24 months after intervention

  17. IPSS quality of life score (Bother-score)

    Measured: Pre-op, 1, 3, 6, 12 and 24 months

  18. EQ-5D utility score

    Measured: Pre-op, 1, 3, 6, 12 and 24 months

  19. Resource utilization: hospital length of stay, OR time, pain medications, follow-up care (e.g. urologist visits, lab tests)

    Measured: Pre-op, 1, 3, 6, 12 and 24 months

  20. Productivity losses

    Measured: Pre-op, 1, 3, 6, 12 and 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2007 (estimated)
  2. Study startJan 2008
  3. Primary completionFeb 2013
  4. Study completionOct 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
164 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00527371
Sponsor's protocol ID
HTA 010-0706-01
Acronym
PVP
Status last verified
Feb 2018
First submitted
6 Sep 2007
Last updated
12 Feb 2018
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 24319513

  • 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.

    PubMed 24019857

Questions about this trial

What is this clinical trial studying?

A study testing GreenLight HPS (TM)laser system [Photoselective Vaporization of the prostate (PVP)] and Transurethral resection of the prostate in people with Benign Prostatic Hyperplasia, run by St. Joseph's Healthcare Hamilton at 3 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary outcome is the change in International Prostatic Symptom Score (IPSS). (time frame: 6-months after surgery versus baseline.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00527371, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2018.

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