Traditional vs Top-Down HoLEP for Enlarged Prostate

Recruiting in Palo Alto (17 mi)

Overseen byHazem Elmansy, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Thunder Bay Regional Research Institute

No Placebo Group

Trial Summary

What is the purpose of this trial?Benign prostatic hyperplasia (BPH), the non-malignant enlargement of the prostate gland, places pressure on the urethra and causes urination difficulties and bladder problems. Lower Urinary Tract Symptoms (LUTS) secondary to BPH is a common condition in aging men, with an overall prevalence of more than 50% in those older than 50 years of age. Men with LUTS often experience sexual dysfunction including ejaculatory loss, painful ejaculation, and erectile dysfunction, which among other complications can also lead to a decreased quality of life. 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 offers patients the alternative of being treated endoscopically with minimal blood loss, short catheterization time, and decreased hospital stay. One noted drawback to HoLEP, and the primary reason why it has yet to become the new standard for treatment of symptomatic BPH, is the complexity of this procedure, with a prolonged learning curve. Modifications to the procedure have thus been explored in order to address this limitation. 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. This study will compare the operating time between the Top-Down Holmium Laser Enucleation of the prostate (HoLEP) and the Traditional HoLEP for the treatment of patients with symptomatic bladder outlet obstruction due to BPH in Northwestern Ontario.

Eligibility Criteria

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.

Inclusion Criteria

I have been referred to a urologist for persistent urinary symptoms due to an enlarged prostate.

My condition did not improve with medication alone.

My prostate symptoms are severe, affecting my quality of life, and my urine flow is very slow.

+4 more

Exclusion 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.

+6 more

Participant Groups

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.

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 \[6\].