Top-Down Holmium Laser Enucleation of the Prostate (HoLEP) vs the Traditional HoLEP for Treatment of Benign Prostatic Hyperplasia (BPH)

NCT04391114 | Active Not Recruiting

• 1 other identifier: 2019518
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Benign Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Outcome Measures

Primary Outcomes (1)

• Operating time

  Length of time required for surgical procedure

  Operating time/Surgery

Secondary Outcomes (7)

• Intraoperative adverse events

  During surgery

• Length of hospital stay

  1-day post-op

• Time to catheter removal

  1-day post-op

• International Prostate Symptom Scores (I-PSS)

  1-year post-op

• Quality of Life (QoL) scores

  1-year post-op

Study Arms (2)

Traditional HoLEP

ACTIVE COMPARATOR

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 \[6\].

Procedure: Traditional HoLEP

Top-Down HoLEP

ACTIVE COMPARATOR

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.

Procedure: Top-Down HoLEP

Interventions

Traditional HoLEP PROCEDURE

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 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 \[6\].

Traditional HoLEP

Top-Down HoLEP PROCEDURE

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.

Top-Down HoLEP

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males over 50 years of age at the time of enrollment
• Referred to urology for refractory LUTS secondary to BPH
• Failed medical (non-surgical) treatment
• Prostate size on preoperative TRUS of \> 80 ml
• IPSS \>15, QOL score ≥3 and Qmax \<15 ml/sec
• Written informed consent to participate in the study
• Ability to comply with the requirements of the study procedures

You may not qualify if:

• Previous surgical treatment for BPH
• Presence of bladder stones
• History of prostate cancer
• Prostate size \< 80 mL
• History of urethral stenosis or its management
• Known or suspected neurogenic bladder
• Participants with active urinary tract infection until appropriately treated
• Participants with preexisting conditions, which, in the opinion of the investigator, interfere with the conduct of the study
• Participants who lack the capacity, or cannot speak English, in order to provide free and informed written consent

Sponsors & Collaborators

• Thunder Bay Regional Health Research Institute: lead

Study Sites (1)

Thunder Bay Regional Health Sciences Centre/Thunder Bay Regional Health Research Institute

Thunder Bay, Ontario, P7B6V4, Canada

Location

MeSH Terms

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hazem Elmansy, MD

  Thunder Bay Regional Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urology Surgeon

Model Details: Prospective comparative randomized controlled trial comparing two standard of care treatments

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: May 18, 2020
• Study Start: October 15, 2019
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 10, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)