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

NCT ID: NCT06922968

Last Updated: 2025-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2026-10-01

Brief Summary

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

Detailed Description

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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.

Conditions

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BPH (Benign Prostatic Hyperplasia)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Control group

Control cases under went TURP and enucleation

Group Type EXPERIMENTAL

Standard TURP and enucleation

Intervention Type PROCEDURE

No TRUS guidance during the procedure (TURP and enucleation)

TRUS Guided group

TRUS guided group during TURP and enucleation

Group Type EXPERIMENTAL

TRUS-Guided TURP and enucleation

Intervention Type PROCEDURE

realtime TRUS guidance during the procedure (TURP and enucleation)

Interventions

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TRUS-Guided TURP and enucleation

realtime TRUS guidance during the procedure (TURP and enucleation)

Intervention Type PROCEDURE

Standard TURP and enucleation

No TRUS guidance during the procedure (TURP and enucleation)

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed ElSharkawy

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed Mohamed Abdel-Moniem Hassanein, professor of Urology

Role: STUDY_DIRECTOR

Assiut University

Locations

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Assiut university

Asyut, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Mohamed mostafa Elsharkawy, assistant lecturer of Urology

Role: CONTACT

+201065811880

Mahmoud Farouk Hassan, lecturer Of Urology

Role: CONTACT

+201009152070

Other Identifiers

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TRUS with TURP and enucleation

Identifier Type: -

Identifier Source: org_study_id

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