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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06922968
Enrollment
114
Registered
2025-04-11
Start date
2025-04-01
Completion date
2026-10-01
Last updated
2025-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

BPH (Benign Prostatic Hyperplasia)

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.

Interventions

PROCEDURETRUS-Guided TURP and enucleation

realtime TRUS guidance during the procedure (TURP and enucleation)

PROCEDUREStandard TURP and enucleation

No TRUS guidance during the procedure (TURP and enucleation)

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
MALE
Age
50 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
efficacy of endoscopic treatment of BPHAt 12 weeks after the procedureIntervention efficacy will be evaluated by comparing the Peak flow rate in ml/second.(measured by uroflowmetry) between the two groups

Countries

Egypt

Contacts

Primary ContactMohamed mostafa Elsharkawy, assistant lecturer of Urology
mhmdsharkawy@aun.edu.eg+201065811880
Backup ContactMahmoud Farouk Hassan, lecturer Of Urology
Mahmoud12@aun.edu.eg+201009152070

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026