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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different sizes of scopes used in Holmium Laser Enucleation of the Prostate (HoLEP), a procedure for treating an enlarged prostate. The goal is to determine if a smaller scope speeds up surgery and eases recovery with fewer complications. The trial compares two scope sizes: 22F and 26F. It seeks men over 50 who have unsuccessfully tried other treatments for urinary issues due to an enlarged prostate and have a prostate size over 80 ml. Participants must be able to follow study procedures. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance surgical outcomes for future patients.

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 prior data suggests that these sheath sizes are safe for HoLEP procedures?

Research has shown that Holmium Laser Enucleation of the Prostate (HoLEP) is generally safe and well-tolerated. Studies have examined different tube sizes used in the procedure, specifically the 22F and 26F sizes. Results suggest both sizes have low rates of complications, such as urethral narrowing and other issues.

One study found that the 22F and 26F tubes offer similar safety levels, indicating a low risk of complications for both. Another study emphasized HoLEP's effectiveness and low complication rates, even for patients with other health conditions.

In summary, current research considers HoLEP a safe procedure, whether using a 22F or 26F tube. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the HoLEP procedure because it offers a refined approach to treating an enlarged prostate. Unlike traditional surgeries like TURP (Transurethral Resection of the Prostate), HoLEP uses a laser to precisely remove excess prostate tissue, which can lead to shorter recovery times and less bleeding. The current trial is exploring the use of different sheath sizes (22F and 26F) during the procedure, potentially making it even less invasive and more comfortable for patients. By optimizing these technical aspects, HoLEP could further improve patient outcomes and set a new standard for treating this common condition.

What evidence suggests that this trial's sheath sizes could be effective for enlarged prostate?

Research has shown that Holmium Laser Enucleation of the Prostate (HoLEP) effectively treats benign prostatic hyperplasia (BPH), a condition characterized by an enlarged prostate. HoLEP is safe and efficient, providing long-lasting results for patients. Studies indicate that HoLEP is effective regardless of prostate size, offering a less invasive option with results comparable to traditional surgery. It reduces symptoms and improves quality of life more effectively than older methods. In this trial, participants will undergo HoLEP using either a 26F or 22F sheath size, and researchers are still studying the differences in outcomes between these sizes. ^{2 6 7 8 9}

Who Is on the Research Team?

Hazem Elmansy

Principal Investigator

Thunder Bay Regional Health Sciences Centre

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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) 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 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) 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 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 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 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]

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]

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]

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Holmium laser enucleation of the prostate (HoLEP) is routinely performed with 24F, 26F, and 28F laser scopes. Proponents of larger caliber ...