HoLEP Sheath Sizes for Enlarged Prostate

Overseen By Shalyn Littlefield

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Thunder Bay Regional Health Research Institute

Disqualifiers: Prostate cancer, Urethral stenosis, Neurogenic bladder, 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: 2

Duration: 1 day

142 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 study team or your doctor.

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

Research shows that HoLEP is effective for treating benign prostatic hyperplasia (BPH), a common condition in older men, regardless of prostate size. It is considered a minimally invasive procedure with excellent long-term outcomes, making it a new standard for BPH treatment. ^{1 2 3 4 5}

Is HoLEP generally safe for treating an enlarged prostate?

Research shows that HoLEP is generally safe for treating an enlarged prostate, with studies evaluating its safety and effectiveness over many years and in thousands of patients. ^{6 7 8 9 10}

How is the treatment Holmium Laser Enucleation of the Prostate (HoLEP) unique for treating enlarged prostate?

HoLEP is unique because it is a minimally invasive treatment that can effectively treat prostates of any size, from small to extremely large, making it a versatile option for benign prostatic hyperplasia (BPH). It uses a laser to remove excess prostate tissue, which can lead to excellent long-term outcomes and is considered the gold standard for surgical treatment of prostate enlargement. ^{3 4 5 11 12}

What is the purpose of this trial?

Holmium laser enucleation of the prostate (HoLEP) is routinely performed with 24F, 26F, and 28F laser scopes. Proponents of larger caliber scopes suggest that the larger scope size allows for improved visualization, hemostasis, and operative efficiencies. Proponents of a smaller scope diameter suggest that by eliminating the need for pre-HoLEP urethral dilation to accommodate a larger scope. It has also been proposed that a smaller caliber scope is less traumatic to the urethra resulting in lower rates of bladder neck contracture and urethral stricture disease. Currently, to our knowledge, there are no level one evaluation examining scope size 22F versus 26F sheath in laser enucleation outcomes. The aim of our study is to determine if a smaller diameter scope is associated with improved laser enucleation time, post-operative recovery, rates of same-day discharge, or increasing intra-operative or postoperative complication rates

Research Team

Hazem Elmansy

Principal Investigator

Thunder Bay Regional Health Sciences Centre

Eligibility Criteria

This trial is for men with benign prostatic hyperplasia (BPH), which means they have an enlarged prostate. The study is looking for participants who haven't had previous treatments that would affect the outcome of this trial.

Inclusion Criteria

Ability to comply with the requirements of the study procedures

I am a man over 50 years old.

Written informed consent to participate in the study

Exclusion Criteria

Participants with preexisting conditions, which, in the opinion of the investigator, interfere with the conduct of the study

I have had surgery for an enlarged prostate.

I do not have an active urinary tract infection, or it is being treated.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Holmium Laser Enucleation of the Prostate (HoLEP) using either a 22F or 26F sheath size

1 day

1 visit (in-person)

Post-operative Recovery

Participants are monitored for post-operative recovery and same-day discharge

Within 6 hours

1 visit (in-person)

Follow-up

Participants are monitored for continence status, quality of life, and other outcomes

1 year

Multiple visits (in-person and virtual)

Treatment Details

Interventions

• Holmium Laser Enucleation of the Prostate (HoLEP)

Trial Overview The study compares two sizes of scopes used in a laser surgery called HoLEP to treat BPH. One group will undergo the procedure with a 22F sheath size, while another will use a larger 26F sheath, to see which results in better outcomes and fewer complications.

Participant Groups

Group I: 26F Sheath Size Active Control 1 Intervention

Comparator arm for procedures using 26F sheath size

Group II: 22F Sheath Size Active Control 1 Intervention

Comparator arm for procedures using 22F sheath size

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?

Thunder Bay Regional Health Research Institute

Lead Sponsor

Trials

11

Recruited

860+

Findings from Research

Holmium laser enucleation of the prostate (HoLEP) is a safe and effective treatment for benign prostatic hyperplasia (BPH), showing significant improvements in urinary flow and symptom scores in 230 patients over a 12-month follow-up period.

The procedure resulted in a substantial reduction in prostate volume (90.8%) and prostate-specific antigen levels (82.5%), with only minor temporary side effects, indicating its efficacy regardless of prostate size.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Holmium laser enucleation of the prostate: initial report of the first 230 Egyptian cases performed in a single center. Abdel-Hakim, AM., Habib, EI., El-Feel, AS., et al.[2010]

Holmium laser enucleation of the prostate (HoLEP) demonstrated lower postoperative morbidity and shorter hospital stays compared to traditional retropubic adenomectomy, making it a safer surgical option for treating benign prostatic hypertrophy.

The study suggests that after performing approximately 50 HoLEP procedures, surgeons can achieve better surgical performance and fewer complications, indicating that this number represents a significant point in the learning curve for this technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Holmium laser enucleation of the prostate and retropubic prostatic adenomectomy: morbidity analysis and anesthesia considerations. Soto-Mesa, D., Amorín-Díaz, M., Pérez-Arviza, L., et al.[2017]

Holmium laser enucleation of the prostate (HoLEP) is a minimally invasive treatment for benign prostatic hyperplasia that offers excellent long-term outcomes, regardless of prostate size.

The paper outlines a step-by-step technique for HoLEP, highlighting various modifications that improve the procedure's safety and efficacy, ultimately leading to a refined 'no-touch' approach that enhances surgical precision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Holmium laser enucleation of the prostate: Problem-based evolution of the technique. de Figueiredo, FCA., Cracco, CM., de Marins, RL., et al.[2021]

Holmium laser enucleation of the prostate (HoLEP) is effective for treating large prostates, including those over 200 cm3, with higher enucleation efficiency observed in larger prostates (1.70 g/min for >200 cm3 compared to 1.05 g/min for <100 cm3).

The procedure is safe and shows no significant differences in patient outcomes, such as symptom scores and quality of life, over an 18-month follow-up period, indicating its consistent efficacy regardless of prostate size.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Holmium laser enucleation of the prostate (HoLEP) for small, large and giant prostatic hyperplasia: tips and tricks. Glybochko, PV., Rapoport, LM., Enikeev, ME., et al.[2018]

Holmium laser enucleation of the prostate (HoLEP) is effective for treating benign prostatic hyperplasia (BPH) in both small (≤80 mL) and large (>80 mL) prostates, as shown in a study of 119 patients.

Postoperative improvements in urinary symptoms and flow rates were similar for both prostate size groups, indicating that HoLEP is a safe and effective treatment option regardless of prostate volume.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the Efficacy of Holmium Laser Enucleation of the Prostate in Treating Prostate Volumes of ≤80 and > 80 mL. Gazel, E., Kaya, E., Yalcin, S., et al.[2019]

Holmium laser enucleation of the prostate (HoLEP) is an effective treatment for benign prostatic hyperplasia (BPH), showing significant improvement in urinary flow and quality of life across all prostate sizes in a study of 97 patients.

While larger prostate sizes required longer operation times and resulted in slightly greater hemoglobin loss, the overall safety profile was good, with low rates of major complications and no need for blood transfusions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Holmium laser enucleation of the prostate: comparison of outcomes according to prostate size in 97 Japanese patients. Seki, N., Tatsugami, K., Naito, S.[2022]

Holmium laser enucleation of the prostate (HoLEP) is a safe and effective treatment for benign prostate hyperplasia (BPH) in real-life settings, as demonstrated by a study of 963 patients over 10 years, showing significant improvements in urinary symptoms and flow rates after 12 months.

The procedure is effective regardless of factors like anticoagulant therapy, bladder stones, or prostate size (≥100 mL), although larger prostates and bladder stone removal may increase operation time without affecting safety or outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Critical analysis of a multicentric experience with holmium laser enucleation of the prostate for benign prostatic hyperplasia: outcomes and complications of 10 years of routine clinical practice. Romero-Otero, J., García-Gómez, B., García-González, L., et al.[2020]

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 more effective and safer than transurethral resection of the prostate (TURP) for patients with prostate volumes less than 100 mL, showing shorter catheterization times, reduced hospital stays, and lower blood transfusion rates across 764 patients in eight studies.

Although HoLEP requires a longer operation time, it removes more tissue and results in better post-surgery outcomes, indicating it may be a preferable option for treating benign prostatic obstruction in smaller prostates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis of efficacy and safety comparing holmium laser enucleation of the prostate with transurethral resection of the prostate for patients with prostate volume less than 100 mL or 100 g. Chen, J., Dong, W., Gao, X., et al.[2022]

Holmium laser enucleation of the prostate (HoLEP) is effective and safe for patients with extremely large prostates, as shown in a study of 502 patients with prostate volumes ranging from less than 100 mL to over 200 mL.

While the procedure took longer for patients with the largest prostates, there were no significant differences in postoperative complications across all groups, indicating that HoLEP can be a reliable treatment option regardless of prostate size.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of holmium laser enucleation of the prostate for extremely large prostatic adenoma in patients with benign prostatic hyperplasia. Kim, M., Piao, S., Lee, HE., et al.[2018]

The MOSES technology laser enucleation of the prostate (MoLEP) demonstrated significantly shorter enucleation and surgical times compared to the standard holmium laser enucleation of the prostate (HoLEP), making it more efficient for treating benign prostate enlargement (BPE).

Postoperative outcomes favored MoLEP with a shorter hospital length of stay, suggesting it could be a viable option for same-day discharge surgeries, while HoLEP showed a trend towards higher rates of recatheterization and urethral stricture, although these were not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does MOSES Technology Enhance the Efficiency and Outcomes of Standard Holmium Laser Enucleation of the Prostate? Results of a Systematic Review and Meta-analysis of Comparative Studies. Gauhar, V., Gilling, P., Pirola, GM., et al.[2023]

Holmium laser enucleation of the prostate (HoLEP) is a safe and effective treatment for benign prostatic hypertrophy (BPH), showing significant improvements in symptoms and urinary flow rates across all prostate sizes in a study of 354 patients over one year.

The procedure's efficiency increases with larger prostate sizes, although larger prostates (over 100 g) are associated with a higher risk of certain complications, such as superficial bladder mucosal injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of prostate size on the outcome of holmium laser enucleation of the prostate. Shah, HN., Sodha, HS., Kharodawala, SJ., et al.[2022]

References

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

Holmium laser enucleation of the prostate: initial report of the first 230 Egyptian cases performed in a single center. [2010]

2. Spain pubmed.ncbi.nlm.nih.gov

Holmium laser enucleation of the prostate and retropubic prostatic adenomectomy: morbidity analysis and anesthesia considerations. [2017]

3. Germany pubmed.ncbi.nlm.nih.gov

Holmium laser enucleation of the prostate: Problem-based evolution of the technique. [2021]

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

Holmium laser enucleation of the prostate (HoLEP) for small, large and giant prostatic hyperplasia: tips and tricks. [2018]

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

Comparison of the Efficacy of Holmium Laser Enucleation of the Prostate in Treating Prostate Volumes of ≤80 and > 80 mL. [2019]

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

Holmium laser enucleation of the prostate: comparison of outcomes according to prostate size in 97 Japanese patients. [2022]

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

Critical analysis of a multicentric experience with holmium laser enucleation of the prostate for benign prostatic hyperplasia: outcomes and complications of 10 years of routine clinical practice. [2020]

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

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

9. China pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis of efficacy and safety comparing holmium laser enucleation of the prostate with transurethral resection of the prostate for patients with prostate volume less than 100 mL or 100 g. [2022]

10. Korea (South) pubmed.ncbi.nlm.nih.gov

Efficacy and safety of holmium laser enucleation of the prostate for extremely large prostatic adenoma in patients with benign prostatic hyperplasia. [2018]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Does MOSES Technology Enhance the Efficiency and Outcomes of Standard Holmium Laser Enucleation of the Prostate? Results of a Systematic Review and Meta-analysis of Comparative Studies. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Influence of prostate size on the outcome of holmium laser enucleation of the prostate. [2022]