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Benign Prostatic HyperplasiaNCT04391114

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

A study testing Traditional HoLEP and Top-Down HoLEP in people with Benign Prostatic Hyperplasia and Lower Urinary Tract Symptoms, run by Thunder Bay Regional Health Research Institute at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 50 years and older, men only
What is being tested?
Traditional HoLEP and Top-Down HoLEP
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
107 participants
Where
1 siteCanada
Study dates
15 Oct 2019to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Thunder Bay Regional Health Sciences Centre/Thunder Bay Regional Health Research Institute

    Thunder Bay, Ontario, P7B6V4

Other trials in Canada

About this study

Official title: The Operative Parameters and Postoperative Outcomes of the Top-Down Holmium Laser Enucleation of the Prostate (HoLEP) Technique vs the Traditional HoLEP for Treatment of Benign Prostatic Hyperplasia (BPH): A Randomized Prospective Comparative Study

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.

Read more

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.

Read the detailed description

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.

Conventional Transurethral Resection of the Prostate (TURP), a surgical technique in which excess prostate tissue is removed using a resectoscope, remains the gold standard treatment in most centres for symptomatic BPH. However, morbidity after TURP is high, especially bleeding requiring blood transfusion (0.4-6.4%) and late postoperative bleeding (1.3-1.7%).

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. The improvement in outcome parameters is durable, and the late complications and reoperation rates reported are very low. 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 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 as compared to TURP. 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. A variation of this method is also being explored in Japan (termed the "en-bloc technique with anteroposterior dissection HoLEP"). 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.

In a recent retrospective review of this technique in Indiana, promising early operative results in a small sample size were demonstrated. The mean enucleation time and mean enucleation rate were both faster when comparing the 49 patients who underwent the top-down technique as compared to those 37 patients who underwent the traditional HoLEP technique. While the results of this particular study are limited by the relatively small number of cases and retrospective nature of the study, the potential value of this technique is evident. A retrospective review of 26 patients who underwent surgery using the en-bloc technique in Japan led to similar conclusions regarding the complexity of the procedure and improvement of rates. While this procedure demonstrates potential over the conventional TURP treatment and traditional HoLEP treatment of symptomatic BPH, the specific techniques of the Top-down technique must be further explored.

Our most recent online publication about Top-Down HoLEP early outcomes in 60 patients who underwent HoLEP between 2017 and 2018 with median prostate volume of 124ml (70-266) demonstrated at 3 months follow-up, the urine stream significantly improved with a median Qmax 23.6 mL/s (17-42). Two patients (3.3%) had urge incontinence, and 2 other patients (3.3%) had stress incontinence at 3 months follow-up.

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.

Being tested
Traditional HoLEP, Top-Down HoLEP
Medical subject headings
Prostatic Hyperplasia, Lower Urinary Tract Symptoms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Traditional HoLEPProcedure or surgery

    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].

  • Top-Down HoLEPProcedure or surgery

    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.

Study groups in NCT04391114
Study groupRoleWhat they receive
Traditional HoLEPActive comparatorHolmium 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].
Receives: Procedure: Traditional HoLEP
Top-Down HoLEPActive comparatorThe "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.
Receives: Procedure: Top-Down HoLEP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Operating time

    Length of time required for surgical procedure

    Measured: Operating time/Surgery

Secondary outcomes (7)
  1. Intraoperative adverse events

    Incidence of bleeding and blood transfusion; and operative time/laser time ratio to be investigated

    Measured: During surgery

  2. Length of hospital stay

    Time participant had to remain in hospital following surgery. Time to be measured in hours and minutes

    Measured: 1-day post-op

  3. Time to catheter removal

    Time until catheter was removed from participant post-surgery. Measured in hours and minutes

    Measured: 1-day post-op

  4. International Prostate Symptom Scores (I-PSS)

    The International Prostate Symptom Score (I-PSS) is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).

    Measured: 1-year post-op

  5. Quality of Life (QoL) scores

    One question asking; "If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that? Scored from 0-6 with 0 being "delighted" and 6 being "terrible". Higher the score, the lower the quality of life.

    Measured: 1-year post-op

  6. peak urine flow rates (Qmax)

    Indicates the maximum urine flow rate. In men peak flow rates (Qmax) greater than 15-20 ml/second are considered normal, rates less than 10 ml/second are considered abnormal. This is measured by Uroflowmetry, also called a uroflow test, which measures the flow and force of urine stream during urination.

    Measured: 1-year post-op

  7. post-void residual urine volume (PVR)

    The amount of urine retained in the bladder after a voluntary void. Incomplete bladder emptying is diagnosed by postvoid catheterization or ultrasonography showing an elevated residual urine volume. A volume < 50 mL is normal; <100 mL is usually acceptable in patients > 65 but abnormal in younger patients

    Measured: 1-year post-op

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2020
  2. Study start15 Oct 2019
  3. Primary completion1 Jun 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective comparative randomized controlled trial comparing two standard of care treatments
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
107 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04391114
Sponsor's protocol ID
2019518
Status last verified
Aug 2024
First submitted
6 May 2020
Last updated
10 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: We have no plan to share individual data with any other researchers. We do plan to present our findings at various national and international conferences in the future... however all participant data will have been de-identified and grouped at that point.

Questions about this trial

What is this clinical trial studying?

A study testing Traditional HoLEP and Top-Down HoLEP in people with Benign Prostatic Hyperplasia and Lower Urinary Tract Symptoms, run by Thunder Bay Regional Health Research Institute at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Operating time (time frame: Operating time/Surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.

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