CompletedNot Applicable

Prostate Vaporization Techniques in Canadian Hospital

Canada55 participantsStarted 2014-05

Plain-language summary

Kingston General Hospital is committed to upgrading the surgical treatment platform for benign prostate surgery. Vaporization Surgery, either laser-vaporization or electo-vaporization is becoming a "standard" of therapy for benign prostatic hyperplasia rather than the traditional transurethral resection of the prostate. However many Canadian hospitals have been slow to adopt an updated program because of evolving competing technology systems as well as unknown cost, efficacy, complication and patient/surgeon satisfaction considerations. KGH has been recognized as a centre of excellence in evaluating medical therapy for BPH and studies from the institution have impacted BPH care nationally and abroad. Laser and other state of the art BPH surgical technologies are being purchased by Ontario hospitals, including the local area, with no prospective assessment process. Kingston is uniquely advantaged to undertake a randomized comparative study of two of the most promising technology platforms because the investigators have the experience and expertise to perform the study in a hospital and surgeon naive institution. The investigators propose to directly compare two vaporization techniques, laser and plasma vaporization systems. The investigators will be able to answer the most important questions in technology introduction and technique into our hospital system - cost, efficacy, safety and satisfaction. The results will inform KGH (and other similar Ontario centres) on the advantage or not (financial and patient care related) of investing in a BPH state of the art vaporization technology.

Who can participate

Age range

45 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male at least 45 years of age. * Peak urinary flow rate at least 4 ml/sec with a voided volume of at least 125 ml. * IPPS symptom score ≥ 12 at screening visit. * Prostate volume on DRE estimated to be \> 30cc. * Voluntarily signed informed consent agreement prior to the performance of any study procedures. Exclusion Criteria: * Any prior invasive intervention for BPH. * PSA level greater than 10 ng/ml at screening without either a negative biopsy or documented explanation of why no biopsy was performed. * Medical condition unfit for surgery * History or current evidence of carcinoma of the prostate. * Documented bacterial prostatitis within the past 3 months. * Known severe bleeding disorder. * Unable to follow protocol directions or sign informed consent due to organic brain or psychiatric disease. * History of alcoholism or any other substance abuse, which, in the opinion of the investigator, would affect compliance with the protocol.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Clarion laser vaporization of the prostate

Timeframe: 3 months

Olympus plasma vaporization of the prostate

Timeframe: 3 months

Trial details

NCT IDNCT03495258

SponsorQueen's University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-07-08

View on ClinicalTrials.gov More Direct Costs Excluding Capital Equipment Purchase trials