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

Assiut University

Status: Not yet enrolling

Conditions: BPH (Benign Prostatic Hyperplasia)

Treatments: Procedure: TRUS-Guided TURP and enucleation; Procedure: Standard TURP and enucleation

Study type: Interventional

Funder types: Other

Identifiers

NCT06922968

TRUS with TURP and enucleation

Details and patient eligibility

About

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

Full 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.

Enrollment: 114 estimated patients

Sex: Male

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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114 participants in 2 patient groups

Control group

Experimental group

Description:

Control cases under went TURP and enucleation

Treatment:

Procedure: Standard TURP and enucleation

TRUS Guided group

Experimental group

Description:

TRUS guided group during TURP and enucleation

Treatment:

Procedure: TRUS-Guided TURP and enucleation