HoLEP Vs BPEP for Large Prostatic Adenoma (enucleation)

Holmium Laser Enucleation of the Prostate Versus Bipolar Transurethral Enucleation of the Prostate in Management of Benign Prostatic Hyperplasia A Randomized Controlled Trial

Benign prostatic hyperplasia (BPH) is one of the most common urinary disorders in elderly males. The symptoms of BPH include impaired physiological and functional well-being, which interferes with daily living.

At present, transurethral resection of the prostate (TURP) is the standard surgical treatment. However, the high rate of complications associated with TURP is a major drawback of this procedure.

Holmium laser enucleation of the prostate (HoLEP) was proven to be an effective surgical treatment for BPH with no prostate size limitation with adequate hemostasis, bipolar enucleation of the prostate (BPEP) has been introduced as an alternative energy source with a promising outcome with equal safety and efficacy

Study Overview

• Status: Completed
• Conditions: Prostate Hyperplasia
• Intervention / Treatment: Procedure: Holmium laser enucleation of the prostate versus bipolar transurethral enucleation of the prostate in management of benign prostatic hyperplasia

Detailed Description

Enlarged prostate represents the most common cause of lower urinary tract symptoms (LUTS) in elderly men including irritative, obstructive urinary symptoms or even urinary retention that significantly affects the quality life (QoL).

Transurethral resection of the prostate (TURP) represents the standard surgical technique for the management of benign prostatic hyperplasia (BPH) with a prostate size less than 80 ml. However, considerable morbidities are associated with larger sizes.

Endoscopic enucleation of the prostate (EEP) has been recognized as a treatment option for large prostatic adenomas, since first described by Hiraoka et.al, in 1986, it started to gain popularity despite the long learning curve. Many studies have evaluated its efficacy against the gold standard open prostatectomy in large prostate size more than 80ml and showed its safety and efficacy.

EEP represents an anatomical surgical technique resembling a surgeon's finger in open prostatectomy where any energy source that provides adequate haemostasis could be used. Many studies concluded that EEP relies on the surgeon's skills rather than the energy source itself. Holmium laser enucleation of the prostate (HoLEP) was first described by Gilling in 1998 and was proven to be effective with no prostate size limitation with adequate haemostasis, recently it has been approved as a standard treatment for large prostatic adenoma, bipolar enucleation of the prostate (BPEP) has been introduced as an alternative energy source with a promising outcome with equal safety and efficacy.

Few studies evaluated both techniques, one study was done by Shoma et al. showing no statistical difference regarding safety and efficacy between both techniques, another study conducted by Enikeev et al. reported earlier recovery and catheter removal with HoLEP compared to BPEP. However, cost-effectiveness was never been evaluated before between both techniques especially in developing countries.

With such scarce information, the investigators aimed through this study to compare these two energy sources in the enucleation procedure of the prostate in terms of safety, efficacy, and cost-effectiveness in the management of BPH in large prostatic adenoma more than 80 ml.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11361
    • Ain Shams University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Men who are fit for surgery and need a surgical resection of the prostate larger than 80 ml including:

  1. Bothersome LUTS with an IPSS score over 19
  2. Refractory hematuria
  3. Upper urinary tract affection
  4. Recurrent UTI secondary to prostatic enlargement
  5. Maximum uroflow rate (Qmax) below 10 ml/sec.
  6. bladder diverticula
  7. Urinary retention whether recurrent acute attacks with failure of medical treatment or chronic retention.

Exclusion Criteria:

• Patients with:

  1. Neurogenic bladder
  2. Previous prostate or urethral surgery
  3. Associated urethral stricture
  4. Prostate cancer diagnosed by TRUS biopsy
  5. Bladder stones,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Holmium laser enucleation of the prostate	Procedure: Holmium laser enucleation of the prostate versus bipolar transurethral enucleation of the prostate in management of benign prostatic hyperplasia; comparison between 2 energy sources of enucleation in management of benign prostatic hyperplasia, holmium laser versus bipolar energy source in trans-urethral enucleation of the prostate
Experimental: bipolar transurethral enucleation of the prostate	Procedure: Holmium laser enucleation of the prostate versus bipolar transurethral enucleation of the prostate in management of benign prostatic hyperplasia; comparison between 2 energy sources of enucleation in management of benign prostatic hyperplasia, holmium laser versus bipolar energy source in trans-urethral enucleation of the prostate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
operative time	form the beginning of endoscopic procedure till catheter insertion	50-120 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enucleation efficacy of HoLEP	Mean Enucleation time (HoLEP) in minutes divided by Mean resected volume in grams	12 months
Enucleation efficacy of BEEP	Mean Enucleation time (BPEP) in minutes/ Mean resected volume in grams	12 months
Mean energy in (HoLEP) in joules	Mean energy in (HoLEP) in joules	intra-operative finding
irrigation fluid	Average Irrigation fluid used in each group in liters	intra-operative finding
catheter removal time	postoperative time till catheter removal	1-7 days
resected volume	resected volume in grams	intra-operative finding
hemoglobin drop	blood loss in dl/ml	intra-operative finding
conversion to other type of surgery	conversion to other types of surgeries like TURP, open surgery, procedure abortion	intra-operative finding
Operative safety:	capsular perforation, Yes/No	intra-operative finding
Operative safety:	morcellation injury, Yes/No	intra-operative finding
early post operative complication	stress incontinence, Yes/No	1 month
early post operative complication	urinary tract infection, Yes/No	1 month
early post operative complication	urine retention, Yes/No	1 month
Postoperative efficacy:	IPSS: international prostate symptom score	12 months
Postoperative efficacy:	QoL: quality of life questionnaire	12 months
Postoperative efficacy:	Qmax (m/sec.) : peak flow rate	12 months
Postoperative efficacy:	PVRU (ml): post voiding residual urine	12 months
Postoperative efficacy:	PSA (ng/ml): prostatic specific antigen	12 months
Postoperative efficacy:	postoperative prostate volume assessment in grams	12 months
cost effectiveness	Running cost in Egyptian pounds of the following: irrigation fluid, hospital stay, fiber, loop, management of complication in each group	12 months
hospital stay	duration of postoperative hospital stay in days	1-7 days
Cost analysis	average running cost evaluation in both procedure	1 year

Collaborators and Investigators

• Sponsor: Ahmed Maher Gamil Ahmed Higazy

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): February 1, 2020
• Study Completion (Actual): February 1, 2020

Study Registration Dates

• First Submitted: February 12, 2020
• First Submitted That Met QC Criteria: February 18, 2020
• First Posted (Actual): February 19, 2020

Study Record Updates

• Last Update Posted (Actual): June 16, 2020
• Last Update Submitted That Met QC Criteria: June 12, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: FWA000017585.

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No