NCT05330156

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 15, 2022

Completed
15 days until next milestone

Study Start

First participant enrolled

April 30, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

April 15, 2022

Status Verified

April 1, 2022

Enrollment Period

1.9 years

First QC Date

March 28, 2022

Last Update Submit

April 8, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (2)

Transurethral resection of the prostate group (TURP).

ACTIVE COMPARATOR

the 1st group of patients will undergone Transurethral resection of the prostate for treatment of BPH

Procedure: Transurethral resection of the prostate

transurethral enucleation of prostate group (TUEP)

ACTIVE COMPARATOR

the 2nd group of patients will undergone Transurethral enucleation of the prostate for treatment of BPH

Procedure: transurethral enucleation of prostate

Interventions

\- 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.

Transurethral resection of the prostate group (TURP).

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.

transurethral enucleation of prostate group (TUEP)

Eligibility Criteria

Sexmale(Gender-based eligibility)
Gender Eligibility DetailsBPH disease is a male disease
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

assiut University

Asyut, 71715, Egypt

Location

Related Publications (1)

  • Mostafa MM, Ibrahim AF, Moeen AM, Elgammal MA, El-Azab AS, Faragallah MA. Bipolar resection versus enucleation of the prostate in management of benign prostatic hyperplasia patients with large-sized prostates: a prospective randomized controlled clinical trial. BMC Urol. 2026 Jan 24. doi: 10.1186/s12894-025-02004-1. Online ahead of print.

MeSH Terms

Interventions

Transurethral Resection of Prostate

Intervention Hierarchy (Ancestors)

ProstatectomyUrologic Surgical Procedures, MaleUrologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • MOHAMED F ABBAS, MD

    AUH

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed F Hassan, Master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

March 28, 2022

First Posted

April 15, 2022

Study Start

April 30, 2022

Primary Completion

March 30, 2024

Study Completion

April 30, 2024

Last Updated

April 15, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations