HoLEP for Prostate Obstruction

Overseen By Allaa Fadl-Alla, BS

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Prostates over 200g, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

300 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary aim is to assess the impact of laser setting frequency and wattage during holmium laser enucleation of the prostate. There is currently no gold-standard laser settings for HoLEP procedures. In the investigator's current high-volume practice, the following settings for enucleation are: 2j 50hz. These settings are conventional settings, but there is no literature to prove optimal laser settings. The investigators hypothesizes that utilization of higher laser settings may be associated with a clinically significant (defined as \> 10%) decrease in procedural time without any detrimental postoperative outcomes, and a utilization of lower laser settings may be associated with a clinically significant (defined as \>10%) reduction in postoperative irritative voiding symptoms without any detrimental postoperative outcomes.

Do I need to stop my current medications for the HoLEP trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Holmium Laser Enucleation of the Prostate (HoLEP) for prostate obstruction?

Research shows that HoLEP is a safe and effective treatment for prostate obstruction, particularly for benign prostatic hyperplasia (BPH), which is an enlarged prostate. Studies indicate that HoLEP is a good alternative to traditional surgery methods, providing long-term relief from urinary symptoms. ^{1 2 3 4 5}

Is HoLEP generally safe for humans?

HoLEP (Holmium Laser Enucleation of the Prostate) is generally considered safe for treating an enlarged prostate, with studies showing it has been performed on thousands of patients with a low rate of complications. It is a minimally invasive procedure, meaning it usually involves less risk and quicker recovery compared to traditional surgery. ^{5 6 7 8 9}

How does the HoLEP treatment differ from other treatments for prostate obstruction?

HoLEP (Holmium Laser Enucleation of the Prostate) is unique because it uses a laser to precisely remove prostate tissue, allowing for the treatment of larger prostates with minimal bleeding. Unlike traditional surgery, it is a minimally invasive procedure performed through the urethra, which can lead to quicker recovery times. ^{1 3 4 5 10}

Research Team

Amy Krambeck, MD

Principal Investigator

Northwestern University

Eligibility Criteria

This trial is for individuals with prostate obstruction or urological diseases who are candidates for HoLEP, a laser treatment to remove prostate tissue. Specific eligibility criteria aren't provided, but typically participants would need to be suitable for the procedure.

Inclusion Criteria

I am a man aged 18-89 getting HoLEP for urinary issues due to an enlarged prostate.

Exclusion Criteria

I am unable to make my own medical decisions.

Prostate measurements over 200g

Non-English speakers

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Holmium Laser Enucleation of the Prostate with varying laser settings (2J 40hz, 2J 50hz, 2J 60hz) to assess the impact on procedural time and postoperative outcomes

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure, focusing on postoperative outcomes and irritative voiding symptoms

2 years

Treatment Details

Interventions

• Holmium Laser Enucleation of the Prostate (HoLEP)

Trial Overview The study tests different laser settings during HoLEP procedures to find out if higher or lower settings affect the surgery time and postoperative outcomes like irritative voiding symptoms without causing harm.

Participant Groups

Group I: 2J 60hz Laser Energy Experimental Treatment 1 Intervention

Patients will under go their Holmium Laser Enucleation procedure with the laser setting: 2J 60hz

Group II: 2J 50hz Laser Energy Experimental Treatment 1 Intervention

Patients will under go their Holmium Laser Enucleation procedure with the laser setting: 2J 50hz

Group III: 2J 40hz Laser Energy Experimental Treatment 1 Intervention

Patients will under go their Holmium Laser Enucleation procedure with the laser setting: 2J 40hz

Holmium Laser Enucleation of the Prostate (HoLEP) is already approved in United States, Canada, European Union for the following indications:

Approved in United States as HoLEP for:

• Benign Prostatic Hyperplasia (BPH)

Approved in Canada as HoLEP for:

• Benign Prostatic Hyperplasia (BPH)

Approved in European Union as HoLEP for:

• Benign Prostatic Hyperplasia (BPH)

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Findings from Research

Holmium laser enucleation (HoLEP) and transurethral resection of the prostate (TURP) both improve urinary flow rates similarly after 6 and 12 months, indicating comparable efficacy in treating prostatic obstruction.

HoLEP offers significant advantages over TURP, including less blood loss, shorter catheterization time, and shorter hospital stays, while maintaining a similar safety profile regarding adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meta-analysis of holmium laser enucleation versus transurethral resection of the prostate for symptomatic prostatic obstruction. Tan, A., Liao, C., Mo, Z., et al.[2007]

Holmium laser enucleation of the prostate (HoLEP) is a safe and effective alternative to traditional surgeries like transurethral resection and open prostatectomy for treating lower urinary tract symptoms caused by benign prostatic enlargement, with low complication rates and minimal need for reintervention.

Long-term follow-up data indicate that HoLEP provides durable functional results, making it a recommended treatment option regardless of prostate size.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Holmium laser enucleation of the prostate and holmium laser ablation of the prostate: indications and outcome. Suardi, N., Gallina, A., Salonia, A., et al.[2008]

Holmium laser enucleation of the prostate (HoLEP) is effective for treating bladder outlet obstruction (BOO) caused by benign prostatic hyperplasia (BPH), showing excellent outcomes across a wide range of patients, including those on anticoagulation and with previous surgeries.

HoLEP has a low immediate complication rate and rare instances of incontinence, although retrograde ejaculation occurs in about 75% of patients; it also has a lower retreatment rate compared to other BPH procedures, indicating its long-term effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Holmium Laser Enucleation of the Prostate: Patient Selection and Outcomes. Kuebker, JM., Miller, NL.[2018]

In a study of 600 patients undergoing Holmium laser enucleation of the prostate (HoLEP) for benign prostate hyperplasia, significant improvements in functional outcomes were observed at 1, 3, and 6 months post-surgery, indicating the procedure's efficacy.

The complication rates were comparable to existing literature, with only one case of persistent stress urinary incontinence, suggesting that HoLEP is a safe and effective alternative to traditional transurethral resection of the prostate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Holmium laser enucleation of the prostate for the treatment of size-independent BPH: A single-center experience of 600 cases. Yalçın, S., Yılmaz, S., Gazel, E., et al.[2020]

Holmium laser enucleation of the prostate (HoLEP) is a safe and effective treatment for benign prostatic hyperplasia, showing significant improvements in urinary symptoms and urodynamic parameters across 190 patients studied.

As surgeons gain experience, the operative time decreases and the rate of complications, such as bladder mucosal injury and urinary incontinence, also declines, indicating that even inexperienced surgeons can perform HoLEP with acceptable safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Holmium laser enucleation of the prostate: the safety, efficacy, and learning experience in China. Du, C., Jin, X., Bai, F., et al.[2016]

In a study of 1,396 men undergoing holmium laser enucleation of the prostate (HoLEP) for lower urinary tract symptoms, the en-bloc technique showed significantly fewer adverse events compared to the traditional 3-lobe method, indicating improved safety.

The en-bloc method was also more efficient, requiring less laser energy and resulting in shorter enucleation times, while maintaining effective symptom relief and functional outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy, Efficiency, and Safety of En-bloc vs Three-lobe Enucleation of the Prostate: A Propensity Score-matched Analysis. Tamalunas, A., Schott, M., Keller, P., et al.[2023]

In a study of 280 patients undergoing holmium laser enucleation of the prostate (HoLEP), the procedure was successfully completed in 95.7% of cases, indicating a high success rate and safety profile.

The overall incidence of complications was low, with most being minor and manageable, such as transient urinary incontinence in 10.7% of patients, which resolved spontaneously in all but two cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peri-operative complications of holmium laser enucleation of the prostate: experience in the first 280 patients, and a review of literature. Shah, HN., Mahajan, AP., Hegde, SS., et al.[2019]

Holmium laser enucleation of the prostate (HoLEP) is a safe and effective treatment for benign prostatic hyperplasia, showing significant improvements in International Prostate Symptom Scores and quality of life after an average follow-up of 32.4 months.

The procedure resulted in fewer complications and faster recovery compared to traditional open surgery, with a low incidence of serious complications and an average hospital stay of just 3.1 days.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Report of 3162 cases of holmium laser enucleation of the prostate and review]. Liu, QG., Li, X., Ma, WQ., et al.[2013]

Holmium laser enucleation of the prostate (HoLEP) is a minimally invasive procedure with a low complication rate, as evidenced by a study of 206 patients where no major complications or deaths occurred, and only 1% required postoperative transfusions.

Most patients (86.9%) were discharged after an overnight stay without a catheter, indicating a quick recovery, with long-term follow-up showing manageable complications such as a 2.4% rate of urethral strictures and bladder neck contractures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Holmium laser enucleation of the prostate: morbidity in a series of 206 patients. Kuo, RL., Paterson, RF., Siqueira, TM., et al.[2019]

Holmium laser enucleation of the prostate (HoLEP) is more effective than transurethral prostate resection (TURP) in terms of reducing catheter time (17.7 hours vs 44.9 hours) and hospital stay (27.6 hours vs 49.9 hours), making it a more efficient option for patients.

While HoLEP takes longer to perform than TURP (62.1 minutes vs 33.1 minutes), it removes more prostate tissue (40.4 grams vs 24.7 grams) and shows similar improvements in urinary symptoms and flow rates at 12 months post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial comparing holmium laser enucleation of the prostate with transurethral resection of the prostate for the treatment of bladder outlet obstruction secondary to benign prostatic hyperplasia in large glands (40 to 200 grams). Tan, AH., Gilling, PJ., Kennett, KM., et al.[2017]

References

1. England pubmed.ncbi.nlm.nih.gov

Meta-analysis of holmium laser enucleation versus transurethral resection of the prostate for symptomatic prostatic obstruction. [2007]

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

Holmium laser enucleation of the prostate and holmium laser ablation of the prostate: indications and outcome. [2008]

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

Holmium Laser Enucleation of the Prostate: Patient Selection and Outcomes. [2018]

4. Turkey pubmed.ncbi.nlm.nih.gov

Holmium laser enucleation of the prostate for the treatment of size-independent BPH: A single-center experience of 600 cases. [2020]

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

Holmium laser enucleation of the prostate: the safety, efficacy, and learning experience in China. [2016]

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

Efficacy, Efficiency, and Safety of En-bloc vs Three-lobe Enucleation of the Prostate: A Propensity Score-matched Analysis. [2023]

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

Peri-operative complications of holmium laser enucleation of the prostate: experience in the first 280 patients, and a review of literature. [2019]

8. China pubmed.ncbi.nlm.nih.gov

[Report of 3162 cases of holmium laser enucleation of the prostate and review]. [2013]

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

Holmium laser enucleation of the prostate: morbidity in a series of 206 patients. [2019]

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

A randomized trial comparing holmium laser enucleation of the prostate with transurethral resection of the prostate for the treatment of bladder outlet obstruction secondary to benign prostatic hyperplasia in large glands (40 to 200 grams). [2017]