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Procedure
Traditional vs Top-Down HoLEP for Enlarged Prostate
N/A
Waitlist Available
Led By Hazem Elmansy, MD
Research Sponsored by Thunder Bay Regional Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Failed medical (non-surgical) treatment
Referred to urology for refractory LUTS secondary to BPH
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-year post-op
Awards & highlights
Study Summary
This trial will compare the two most common types of surgery for treating an enlarged prostate. HoLEP is a newer, less invasive type of surgery that has a shorter hospital stay, but a longer learning curve for surgeons. The "Top-Down" HoLEP technique is a novel technique which offers potential benefits to the Traditional HoLEP procedure, including decreased complexity, a reduced learning curve.
Who is the study for?
This trial is for men over 50 with severe urinary symptoms from an enlarged prostate (BPH) who haven't improved with non-surgical treatments. They must have a prostate size >80 ml, be able to follow study procedures, and give informed consent in English. Men with active infections, previous BPH surgery, bladder stones, prostate cancer or certain other conditions are excluded.Check my eligibility
What is being tested?
The study compares two surgical techniques using lasers to remove prostate tissue: the traditional HoLEP method and a newer 'Top-Down' HoLEP that might be simpler and quicker to learn. The goal is to see if Top-Down HoLEP reduces operation time while helping symptoms of BPH.See study design
What are the potential side effects?
Potential side effects include but are not limited to bleeding, infection risk post-operation, temporary difficulty urinating requiring catheter use, sexual dysfunction such as ejaculatory problems or erectile dysfunction which can affect quality of life.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition did not improve with medication alone.
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I have been referred to a urologist for persistent urinary symptoms due to an enlarged prostate.
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My prostate symptoms are severe, affecting my quality of life, and my urine flow is very slow.
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I am a man over 50 years old.
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My prostate is larger than 80 ml as measured before surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1-year post-op
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-year post-op
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Operating time
Secondary outcome measures
International Prostate Symptom Scores (I-PSS)
Intraoperative adverse events
Length of hospital stay
+4 moreTrial Design
2Treatment groups
Active Control
Group I: Top-Down HoLEPActive Control1 Intervention
The "Top-Down" HoLEP technique is a novel technique which offers potential benefits to the Traditional HoLEP procedure, including decreased complexity, a reduced learning curve, with anticipated improved continence [8]. A variation of this method is also being explored in Japan (termed the "en-bloc technique with anteroposterior dissection HoLEP") [9]. The main difference between the Top-Down and Traditional approach is that the direction of lateral dissection begins from upwards to downwards. This could help in avoiding the overtraction of the mucosal strip overlying the posterior urethral sphincter, which theoretically leads to a decrease in the incidence of postoperative stress incontinence. Moreover, using the Top-Down approach should lead to a decrease in the incidence of lost enucleation planes, which results in decreasing the intraoperative time and decreasing the number of cases required to master the HoLEP technique.
Group II: Traditional HoLEPActive Control1 Intervention
Holmium laser enucleation of the prostate (HoLEP), first reported by Fraundorfer et al in 1998, is a more recent step in the evolution of holmium laser prostatectomy. HoLEP is a safe and effective procedure which has demonstrated comparable results to Transurethral Resection of the Prostate (TURP) and open prostatectomy for patients with symptomatic enlarged prostate, with low morbidity and short hospital stay [4]. The improvement in outcome parameters is durable, and the late complications and reoperation rates reported are very low [5]. HoLEP is equally suitable for small, medium and larger prostate glands, with clinical outcomes that are independent of prostate size, unlike TURP. HOLEP offers patients the alterative of being treated endoscopically with minimal blood loss, short catheterization time, and decreased hospital stay [6].
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Who is running the clinical trial?
Thunder Bay Regional Research InstituteLead Sponsor
8 Previous Clinical Trials
727 Total Patients Enrolled
Thunder Bay Regional Health Research InstituteLead Sponsor
8 Previous Clinical Trials
727 Total Patients Enrolled
Northern Ontario School of MedicineOTHER
10 Previous Clinical Trials
815 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of prostate cancer.I am able to understand and consent to the study in English.I have a history of narrowed urethra or its treatment.I have been referred to a urologist for persistent urinary symptoms due to an enlarged prostate.My condition did not improve with medication alone.I do not have an active urinary tract infection, or it is being treated.I have had surgery for an enlarged prostate.My prostate symptoms are severe, affecting my quality of life, and my urine flow is very slow.I am a man over 50 years old.My prostate is larger than 80 ml as measured before surgery.My prostate is smaller than 80 mL.I have bladder stones.I have bladder control issues due to nerve problems.
Research Study Groups:
This trial has the following groups:- Group 1: Top-Down HoLEP
- Group 2: Traditional HoLEP
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment for this trial still ongoing?
"Clinicaltrials.gov records confirm that, despite being posted on October 15th 2019, this particular study is not presently taking in participants. Fortunately, there are 156 other clinical trials actively recruiting patients at the moment."
Answered by AI
What are the essential goals of this investigation?
"This medical trial is expected to compare the operating time, International Prostate Symptom Scores (I-PSS), Quality of Life (QoL) scores and peak urine flow rates between cohorts undergoing Top-Down Holmium Laser Enucleation of the prostate (HoLEP) and traditional HoEP procedures. I-PSS measures range from 0 to 35 points with higher numbers indicating greater severity, while QOL evaluates patient sentiment on their condition in a 6 point scale ranging from "delighted" to "terrible". Uroflowmetry determines peak urine flow rate with normal values typically exceeding 15ml/second."
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