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NCT Number: NCT06922968

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

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

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Key information

Age range

50 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Assiut university

Asyut, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TRUS-Guided TURP and enucleation

Procedure

realtime TRUS guidance during the procedure (TURP and enucleation)

Standard TURP and enucleation

Procedure

No TRUS guidance during the procedure (TURP and enucleation)

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Mahmoud Farouk Hassan, lecturer Of Urology

CONTACT

[email protected]

+201009152070

Mohamed mostafa Elsharkawy, assistant lecturer of Urology

CONTACT

[email protected]

+201065811880

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 11, 2025
Registry last updated
Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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