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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

Must not have

Previous surgical treatment for BPH

History of prostate cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1-year post-op

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had surgery for an enlarged prostate.

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I have a history of prostate cancer.

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I am able to understand and consent to the study in English.

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I have a history of narrowed urethra or its treatment.

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My prostate is smaller than 80 mL.

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I have bladder stones.

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I have bladder control issues due to nerve problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-year post-op

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1-year post-op

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-year post-op for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Operating time

Secondary study objectives

International Prostate Symptom Scores (I-PSS)

Intraoperative adverse events

Length of hospital stay

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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 \[6\].

0 / 12Eligibility criteria met