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

Not Applicable

Not yet recruiting

• Conditions: BPH (Benign Prostatic Hyperplasia)

• Registration Number: NCT06922968
• Lead Sponsor: Assiut University

Brief Summary

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

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 Timeline

• Study First Submitted: 2025-03-17
• Status Verified: 2025-04
• Study Start: 2025-04-01
• Study First Submitted QC: 2025-04-09
• Last Update Submitted: 2025-04-09
• Study First Posted: 2025-04-11
• Last Update Posted: 2025-04-11
• Primary Completion: 2026-10-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 114

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
efficacy of endoscopic treatment of BPH	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

Trial Locations

Locations (1)

Assiut university; 🇪🇬 Assiut, Egypt