Traditional vs Top-Down HoLEP for Enlarged Prostate

Overseen By Imran Malik, MSc

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Thunder Bay Regional Research Institute

Disqualifiers: Previous BPH surgery, Bladder stones, Prostate cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: During surgery

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two techniques for treating an enlarged prostate, a condition that makes urination difficult for many men. The study compares the Traditional HoLEP procedure to a new method called Top-Down HoLEP, which might be easier to learn and could improve continence (control over urination). Men experiencing serious urination problems due to an enlarged prostate, who have not found success with non-surgical treatments, might be suitable candidates for this trial. As an unphased trial, it offers participants the chance to contribute to innovative research that could lead to improved treatment options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these HoLEP techniques are safe for treating BPH?

Research has shown that Holmium Laser Enucleation of the Prostate (HoLEP) is a safe and effective treatment for an enlarged prostate, with few side effects. Studies have found that HoLEP, including the newer Top-Down technique, results in less blood loss and shorter hospital stays compared to open surgery.

Both the Top-Down and Traditional HoLEP have low complication rates, even for men over 75. The procedure improves urinary symptoms and is generally well-tolerated. The new Top-Down HoLEP might simplify the procedure and speed up recovery, but both techniques remain safe and effective. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it compares two techniques for treating an enlarged prostate: Top-Down HoLEP and Traditional HoLEP. The Top-Down HoLEP technique is unique due to its upward-to-downward direction of dissection, which could reduce the risk of stress incontinence and shorten surgery time by making it easier to master. Traditional HoLEP, on the other hand, is already a well-established procedure known for its effectiveness and safety, offering endoscopic treatment with minimal blood loss and a short hospital stay. This trial aims to determine if the novel Top-Down approach offers significant advantages over the traditional method, potentially leading to better patient outcomes and a simpler learning curve for surgeons.

What evidence suggests that this trial's treatments could be effective for BPH?

This trial compares two techniques for Holmium laser enucleation of the prostate (HoLEP) in treating an enlarged prostate, also known as benign prostatic hyperplasia (BPH). Research has shown that HoLEP effectively improves urinary function with a low risk of complications. Studies have found that HoLEP outperforms the traditional method, transurethral resection of the prostate (TURP), and requires less recovery time than open surgery. In this trial, participants will be assigned to either the Traditional HoLEP or the newer Top-Down HoLEP method. The Top-Down HoLEP might simplify the learning process and could enhance bladder control after surgery. Both Traditional and Top-Down HoLEP are safe and effective options for men with BPH, offering similar benefits. ^{1 4 6 7 8}

Who Is on the Research Team?

Hazem Elmansy, MD

Principal Investigator

Thunder Bay Regional Health Sciences Centre

Are You a Good Fit for This Trial?

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

My condition did not improve with medication alone.

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

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

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either the Top-Down HoLEP or Traditional HoLEP procedure for the treatment of BPH

During surgery

1 visit (in-person)

Postoperative Recovery

Participants recover from surgery, including catheter removal and monitoring for intraoperative adverse events

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness, including assessments of urinary symptoms, quality of life, and urine flow rates

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Top-Down HoLEP
• Traditional HoLEP

Trial Overview 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.

How Is the Trial Designed?

Group I: Top-Down HoLEP Active Control 1 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 HoLEP Active Control 1 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 \[6\].

Who Is Running the Clinical Trial?

Thunder Bay Regional Research Institute

Lead Sponsor

Trials

9

Recruited

620+

Thunder Bay Regional Health Research Institute

Lead Sponsor

Trials

11

Recruited

860+

Northern Ontario School of Medicine

Collaborator

Trials

11

Recruited

920+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8158276/

'Top-Down' holmium laser enucleation of the prostate. ... HoLEP has better outcomes than traditional TURP and less morbidity than open prostatectomy [12,13]. However, the major drawback for the widespread application ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04391114

Top-Down Holmium Laser Enucleation of the Prostate ... HoLEP is a safe and effective procedure which has demonstrated comparable results to TURP and open prostatectomy for patients with symptomatic enlarged prostate ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11059977/

Holmium Laser Enucleation of Prostate: Is novel En Bloc ... En bloc and 2-lobe techniques of HoLEP showed similar postoperative outcomes in terms of improvement in Qmax and drop in hemoglobin. However, the enucleation ...

4. frontiersin.org frontiersin.org/journals/surgery/articles/10.3389/fsurg.2024.1358701/full

Patient reported outcome and quality of life measured by a ... This study underlines the effectiveness and safety of HoLEP using a high power Holmium Laser even in high-risk patients with anticoagulation and ...

5. urotoday.com urotoday.com/recent-abstracts/men-s-health/bph-benign-prostatic-enlargement/147204-top-down-holmium-laser-enucleation-of-the-prostate-holep-versus-traditional-holep-for-the-treatment-of-benign-prostatic-hyperplasia-bph-1-year-outcomes-of-a-randomized-controlled-trial.html

Top-down holmium laser enucleation of the prostate ... The HoLEP procedure significantly improves patients' urinary functional outcomes and has comparable postoperative outcomes regardless of the ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04391114

Top-Down Holmium Laser Enucleation of the Prostate ... HoLEP is a safe and effective procedure which has demonstrated comparable results to TURP and open prostatectomy for patients with symptomatic enlarged prostate ...

7. tau.amegroups.org tau.amegroups.org/article/view/61929/html

Efficacy and safety of holmium laser enucleation of the ... Conclusions: HoLEP could be safe and effective even for men aged ≥75 years, comparing complications, urinary condition, and KHQ scores. Keywords ...

8. researchgate.net researchgate.net/publication/363713821_Outcomes_of_Top-Down_Holmium_Laser_Enucleation_of_Prostate_for_RecurrentResidual_Benign_Prostatic_Hyperplasia_One-Year_Follow-Up

(PDF) Outcomes of Top-Down Holmium Laser Enucleation ... Conclusions: For managing recurrent and nonrecurrent cases of BPH, top-down HoLEP is safe with comparable urinary functional outcomes. Patients ...