Real-Time (TRUS) Guidance in Endoscopic Treatment of BPH

April 9, 2025 updated by: Mohamed ElSharkawy, Assiut University

Standard Versus Transrectal Ultrasound (TRUS)-Guided Endoscopic Treatment of Benign Prostatic Hyperplasia: A Prospective Randomized Controlled Trial

The study aims to evaluate the role of TRUS in improving the efficacy and safety of endoscopic enucleation of prostate and TURP.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Standard TURP is an established procedure for managing BPH but has limitations, including the risk of incomplete adenoma removal and complications such as bleeding. Research on transurethral enucleation techniques has demonstrated potential for improved outcomes, especially in larger prostates. However, challenges persist in achieving precise resection boundaries and minimizing intraoperative risks.

TRUS, widely utilized for prostate biopsy and volume assessment, has recently gained attention for its intraoperative applications. Studies show that real-time TRUS provides accurate imaging of prostate anatomy and resection planes, helping surgeons better differentiate adenomatous tissue from surrounding structures. This enhances surgical precision, reduces intraoperative bleeding, and minimizes residual tissue, leading to better outcomes in procedures like TURP and enucleation.

Current TURP and enucleation approaches depend heavily on endoscopic visual guidance, which, despite significant advancements, can lead to residual tissue, excessive bleeding, and prolonged recovery. While enucleation techniques have addressed some of these challenges, they remain less accessible due to high costs and steep learning curves, making them unsuitable for all healthcare settings.

Integrating TRUS into TURP or enucleation offers the potential to address these limitations by enhancing tissue differentiation and guiding precise resection. This study aims to evaluate the efficacy of TRUS in reducing complications, achieving complete tissue removal, and improving patient recovery outcomes, potentially paving the way for its routine adoption in BPH surgery.

Study Type

Interventional

Enrollment (Estimated)

114

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mohamed mostafa Elsharkawy, assistant lecturer of Urology
  • Phone Number: +201065811880
  • Email: mhmdsharkawy@aun.edu.eg

Study Contact Backup

  • Name: Mahmoud Farouk Hassan, lecturer Of Urology
  • Phone Number: +201009152070
  • Email: Mahmoud12@aun.edu.eg

Study Locations

  • Egypt
      • Assiut, Egypt
        • Assiut University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male patients aged 50-80 years
  • Diagnosed with benign prostatic hyperplasia (BPH) and scheduled for TURP or prostatic adenoma enucleation.
  • The patients have clear indication 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Control group
Control cases under went TURP and enucleation
Procedure: Standard TURP and enucleation
No TRUS guidance during the procedure (TURP and enucleation)
Experimental: TRUS Guided group
TRUS guided group during TURP and enucleation
Procedure: TRUS-Guided TURP and enucleation
realtime TRUS guidance during the procedure (TURP and enucleation)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
efficacy of endoscopic treatment of BPH
Time Frame: At 12 weeks after the procedure
Intervention efficacy will be evaluated by comparing the Peak flow rate in ml/second.(measured by uroflowmetry) between the two groups
At 12 weeks after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Ahmed Mohamed Abdel-Moniem Hassanein, professor of Urology, Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

March 17, 2025

First Submitted That Met QC Criteria

April 9, 2025

First Posted (Actual)

April 11, 2025

Study Record Updates

Last Update Posted (Actual)

April 11, 2025

Last Update Submitted That Met QC Criteria

April 9, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRUS with TURP and enucleation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

to put protect privacy of participants

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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