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

107 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Top-Down HoLEP for enlarged prostate?

Research shows that both Top-Down HoLEP and Traditional HoLEP are effective for treating an enlarged prostate, with studies indicating good outcomes in terms of symptom relief and quality of life improvements. The Top-Down HoLEP technique is a safe and effective modification of the traditional method, providing similar benefits. ^{1 2 3 4 5}

Is HoLEP safe for treating an enlarged prostate?

HoLEP, including both traditional and top-down methods, is generally considered safe for treating an enlarged prostate, with studies showing less blood loss and shorter hospital stays compared to other surgical options. ^{1 3 6 7 8}

How does Top-Down HoLEP treatment differ from other treatments for enlarged prostate?

Top-Down HoLEP is a modified version of the traditional HoLEP technique for treating an enlarged prostate, offering a potentially safer and more effective approach by using a laser to remove prostate tissue from the top down. This method may result in better outcomes compared to traditional HoLEP, with less bleeding and shorter recovery times than other surgical options like open prostatectomy or TURP (transurethral resection of the prostate). ^{1 3 6 7 9}

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.

Research Team

Hazem Elmansy, MD

Principal Investigator

Thunder Bay Regional Health Sciences Centre

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.

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Holmium laser enucleation of the prostate (HoLEP): the endourologic alternative to open prostatectomy. [2022]

2. Egypt pubmed.ncbi.nlm.nih.gov

Outcomes of Top-Down Holmium Laser Enucleation of Prostate for Recurrent/Residual Benign Prostatic Hyperplasia: One-Year Follow-Up. [2022]

3. England pubmed.ncbi.nlm.nih.gov

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. [2023]

4. China pubmed.ncbi.nlm.nih.gov

[Holmium laser enucleation versus open prostatectomy for large volume benign prostatic hyperplasia: a meta-analysis of the therapeutic effect and safety]. [2012]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Holmium Laser Enucleation of the Prostate Provides Similar Incidental Prostate Cancer Detection Rates as Open Prostatectomy: A Matched Pair Analysis. [2019]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Holmium laser enucleation of the prostate in Jehovah's Witness patients. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Feasibility of holmium laser enucleation of the prostate (HoLEP) for recurrent/residual benign prostatic hyperplasia (BPH). [2013]

8. United States pubmed.ncbi.nlm.nih.gov

A Systematic Review and Meta-analysis of Efficacy and Safety Following Holmium Laser Enucleation of Prostate and Transurethral Resection of Prostate for Benign Prostatic Hyperplasia. [2020]

9. Germany pubmed.ncbi.nlm.nih.gov

'En Bloc' HoLEP with early apical release in men with benign prostatic hyperplasia. [2021]