HoLEP Vs BPEP for Large Prostatic Adenoma

NCT04275076 | Completed Phase 3

• 1 other identifier: FWA000017585.
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Prostate Hyperplasia

Outcome Measures

Primary Outcomes (1)

• operative time

  form the beginning of endoscopic procedure till catheter insertion

  50-120 minutes

Secondary Outcomes (22)

• Enucleation efficacy of HoLEP

  12 months

• Enucleation efficacy of BEEP

  12 months

• Mean energy in (HoLEP) in joules

  intra-operative finding

• irrigation fluid

  intra-operative finding

• catheter removal time

  1-7 days

Study Arms (2)

Holmium laser enucleation of the prostate

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

bipolar transurethral 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

Interventions

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

Holmium laser enucleation of the prostate; bipolar transurethral enucleation of the prostate

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Men who are fit for surgery and need a surgical resection of the prostate larger than 80 ml including:
• Bothersome LUTS with an IPSS score over 19
• Refractory hematuria
• Upper urinary tract affection
• Recurrent UTI secondary to prostatic enlargement
• Maximum uroflow rate (Qmax) below 10 ml/sec.
• bladder diverticula
• Urinary retention whether recurrent acute attacks with failure of medical treatment or chronic retention.

You may not qualify if:

• Patients with:
• Neurogenic bladder
• Previous prostate or urethral surgery
• Associated urethral stricture
• Prostate cancer diagnosed by TRUS biopsy
• Bladder stones,

Sponsors & Collaborators

• Ahmed Maher Gamil Ahmed Higazy: lead

Study Sites (1)

Ain Shams University Hospitals

Cairo, 11361, Egypt

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: patients, data collector, and the statistician all were blinded to the type of intervention that was used in each group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: assistant lecturer of urology/ Specialist

Study Record Dates

• First Submitted: February 12, 2020
• First Posted: February 19, 2020
• Study Start: February 1, 2018
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: June 16, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)