Transurethral Resection Versus Transurethral Enucleation of the Prostate: Prospective Randomized Study (Prostate)

TUERP technique could be used in prostates of all sizes with the same safety and efficacy "size independent procedure" . TUERP could be performed using the bipolar system only ,with or without the use of morcellator.

Study Overview

• Status: Not yet recruiting
• Conditions: BPH
• Intervention / Treatment: Procedure: Transurethral resection of the prostate; Procedure: transurethral enucleation of prostate

Detailed Description

Transurethral resection of the prostate (TURP) was first done in the 1920s. Since then, TURP has been considered as the gold standard treatment for BPH . However, its relatively high complication rate and postoperative recurrence necessitates further modification in the surgery technique .The resected adenomas have been reported to recur in up to 15% of cases that need a repeat surgical intervention, even by experienced surgeons in high-volume centers .

Before the era of TURP, simple open prostatectomy was the mainstay of surgical therapy. However, open simple prostatectomy has high risk of considerable intraoperative bleeding requiring transfusion. The lower abdominal incision done in open prostatectomy may result in significant postoperative pain, an extended recovery period and longer hospital stay, with greater morbidity and a perioperative mortality rate of 0.2%. In addition, TURP for large prostatic adenomas causes significantly much more bleeding with clot retention as compared to simple open prostatectomy, it also need a longer operative time, which leads to increased risk of TUR syndrome with subsequent morbidity . A new technique in which transurethral enucleation and resection of the prostate (TUERP) was developed and adopted to replicate the open enucleation of prostatic adenomas in an endoscopic way. This will combine the benefits of complete prostate enucleation in a minimally invasive technique . prostate enucleation by laser currently used as minimally invasive and save alternative to TURP, but still has not been widely accepted for some reasons, including high cost and prolonged learning curve.

TUERP technique could be used in prostates of all sizes with the same safety and efficacy "size independent procedure" . TUERP could be performed using the bipolar system only ,with or without the use of morcellator

• Study Type: Interventional
• Enrollment (Anticipated): 58
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed F Hassan, Master; Phone Number: 01069569946; Email: ahmedfarahat358@gmail.com
• Study Contact Backup: Name: AHMED F HASSAN; Phone Number: 01156522620; Email: ahmedfarahat358@gmail.com

Study Locations

• Egypt
  • Assiut, Egypt, 71715
    • Assiut University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• -Patients aging from 50 to 80 years old who are diagnosed with clinical symptomatic BPH.
• The patients have clear indi¬cation for endoscopic surgery (according to the guidelines).
• Clinically fit patients for surgery.
• Signed an informed consent.

Exclusion Criteria:

• Prostate cancer Previous urethral or prostate surgery Neurogenic bladder Urethral stricture Poor general condition of the patient

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Transurethral resection of the prostate group (TURP).; the 1st group of patients will undergone Transurethral resection of the prostate for treatment of BPH	Procedure: Transurethral resection of the prostate; - After an initial cysto-urethroscopy assessment done, Transurethral resection of the prostate is performed using the bipolar system with normal saline irrigation, under spinal or general anesthesia.
Active Comparator: transurethral enucleation of prostate group (TUEP); the 2nd group of patients will undergone Transurethral enucleation of the prostate for treatment of BPH	Procedure: transurethral enucleation of prostate; After an initial cysto-urethroscopy assessment done, transurethral enucleation of prostate is performed using the bipolar system with normal saline irrigation, under spinal or general anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of operation	time used for resection or enucleation and resection of the prostate	intraoperative (from the start of resection or enucleation till the fixation of urethral catheter)

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: MOHAMED F ABBAS, MD, AUH

Study record dates

Study Major Dates

• Study Start (Anticipated): April 30, 2022
• Primary Completion (Anticipated): March 30, 2024
• Study Completion (Anticipated): April 30, 2024

Study Registration Dates

• First Submitted: March 28, 2022
• First Submitted That Met QC Criteria: April 8, 2022
• First Posted (Actual): April 15, 2022

Study Record Updates

• Last Update Posted (Actual): April 15, 2022
• Last Update Submitted That Met QC Criteria: April 8, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: TURP

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
• product manufactured in and exported from the U.S.: No