HoLEP Sheath Sizes for Enlarged Prostate
Recruiting in Palo Alto (17 mi)
Overseen byHazem Elmansy
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Thunder Bay Regional Health Research Institute
Disqualifiers: Prostate cancer, Urethral stenosis, Neurogenic bladder, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
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
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.
12345Is 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.
678910How 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.
3451112Eligibility 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
+4 more
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.
+4 more
Trial 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)
Participant Groups
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.
2Treatment groups
Active Control
Group I: 26F Sheath SizeActive Control1 Intervention
Comparator arm for procedures using 26F sheath size
Group II: 22F Sheath SizeActive Control1 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)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Thunder Bay Regional Health Sciences CentreThunder Bay, Canada
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Who Is Running the Clinical Trial?
Thunder Bay Regional Health Research InstituteLead Sponsor
References
Holmium laser enucleation of the prostate: initial report of the first 230 Egyptian cases performed in a single center. [2010]To report our experience with the first 230 cases of holmium laser enucleation of the prostate (HoLEP) performed in a single center.
Holmium laser enucleation of the prostate and retropubic prostatic adenomectomy: morbidity analysis and anesthesia considerations. [2017]Holmium laser enucleation of the prostate (HoLEP) is an alternative to prostatic adenomectomy for the surgical treatment of benign prostatic hypertrophy. We analyzed our learning curve for this technique, and we compared it in a secondary manner with prostatic adenomectomy.
Holmium laser enucleation of the prostate: Problem-based evolution of the technique. [2021]Holmium laser enucleation of the prostate (HoLEP) is a minimally invasive and size-independent treatment for benign prostatic hyperplasia with excellent long-term surgical outcome. Considered difficult to learn, different modifications of the technique have been proposed in the last 21 years to overcome the most common problems encountered during this procedure. We present a step-by-step technique including the reasons and advantages of each modification we have progressively adopted until we evolved into our totally en-bloc no-touch low-power HoLEP.
Holmium laser enucleation of the prostate (HoLEP) for small, large and giant prostatic hyperplasia: tips and tricks. [2018]Holmium laser enucleation of the prostate (HoLEP) allows to treat extremely large prostates (>200 cm3). The aim of the study was to compare the efficiency of HoLEP for prostates of different sizes.
Comparison of the Efficacy of Holmium Laser Enucleation of the Prostate in Treating Prostate Volumes of ≤80 and > 80 mL. [2019]Holmium laser enucleation of the prostate (HoLEP) is becoming the new standard procedure for treating benign prostatic hyperplasia (BPH), a common condition in aging men. Most studies have focused on proving its efficacy in treating large prostates. In this study, we compared its efficacy in treating small ( 80 mL) prostates.
Holmium laser enucleation of the prostate: comparison of outcomes according to prostate size in 97 Japanese patients. [2022]To review the outcomes associated with holmium laser enucleation of the prostate (HoLEP) to identify the efficacy and safety in relation to the prostate size in subjects with symptomatic benign prostatic hyperplasia (BPH).
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]To assess the perioperative outcomes of holmium laser enucleation of the prostate (HoLEP) in real-life practice and investigate the factors influencing the safety and effectiveness of the technique.
[Report of 3162 cases of holmium laser enucleation of the prostate and review]. [2013]To evaluate the safety, effectiveness, and outcomes of holmium laser enucleation of the prostate (HoLEP) for patients with symptomatic enlarged prostate after 11 years of experience.
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]To assess the efficacy and safety of holmium laser enucleation of the prostate (HoLEP) and transurethral resection of the prostate (TURP) for patients with prostate volume less than 100 mL or 100 g.
Efficacy and safety of holmium laser enucleation of the prostate for extremely large prostatic adenoma in patients with benign prostatic hyperplasia. [2018]To evaluate the efficacy and safety of holmium laser enucleation of the prostate (HoLEP) for extremely large prostates.
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]Holmium laser enucleation of the prostate (HoLEP) is currently the size-independent gold standard for surgical treatment of benign prostate enlargement (BPE).
Influence of prostate size on the outcome of holmium laser enucleation of the prostate. [2022]To analyse the effect of prostate size on the outcome of holmium laser enucleation of prostate (HoLEP, an established procedure for treating symptomatic benign prostatic hypertrophy, BPH), in the initial 354 patients at 1 year of follow-up.