HoLEP Vs BPEP for Large Prostatic Adenoma

NCT ID: NCT04275076

Last Updated: 2020-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2020-02-01

Brief Summary

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

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.

Conditions

Prostate Hyperplasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Holmium laser enucleation of the prostate

Holmium laser enucleation of the prostate

Group Type: EXPERIMENTAL

Holmium laser enucleation of the prostate versus bipolar transurethral enucleation of the prostate in management of benign prostatic hyperplasia

Intervention Type: PROCEDURE

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

bipolar transurethral enucleation of the prostate

bipolar transurethral enucleation of the prostate

Group Type: EXPERIMENTAL

Holmium laser enucleation of the prostate versus bipolar transurethral enucleation of the prostate in management of benign prostatic hyperplasia

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

Eligibility Criteria

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,

• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Ahmed Maher Gamil Ahmed Higazy

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Maher Gamil Ahmed Higazy

assistant lecturer of urology/ Specialist

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Ain Shams University Hospitals

Cairo, , Egypt

Countries

Egypt

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

FWA000017585.

Identifier Type: -

Identifier Source: org_study_id