Real-Time (TRUS) Guidance in Endoscopic Treatment of BPH | NCT06922968

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

NCT06922968

Sponsor

Assiut University

Status

Not yet recruiting

Last Update Posted

Apr 11, 2025Actual

Enrollment

114Estimated

Phase

Not Applicable

Conditions

BPH (Benign Prostatic Hyperplasia)

Interventions

TRUS-Guided TURP and enucleation
Standard TURP and enucleation

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2025Estimated

Primary Completion Date

Oct 1, 2026Estimated

Completion Date

Oct 1, 2026Estimated

First Submitted Date

Mar 17, 2025

First Submission Date that Met QC Criteria

Apr 9, 2025

First Posted Date

Apr 11, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 9, 2025

Last Update Posted Date

Apr 11, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mohamed ElSharkawy, Principal Investigator, Assiut UniversityPrincipal Investigator

Lead Sponsor

Assiut UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

114Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control group	Experimental	Control cases under went TURP and enucleation	Procedure: Standard TURP and enucleation
TRUS Guided group	Experimental	TRUS guided group during TURP and enucleation	Procedure: TRUS-Guided TURP and enucleation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TRUS-Guided TURP and enucleation	Procedure	realtime TRUS guidance during the procedure (TURP and enucleation)	TRUS Guided group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
efficacy of endoscopic treatment of BPH	Intervention efficacy will be evaluated by comparing the Peak flow rate in ml/second.(measured by uroflowmetry) between the two groups	At 12 weeks after the procedure

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mohamed mostafa Elsharkawy, assistant lecturer of Urology	Contact	+201065811880		mhmdsharkawy@aun.edu.eg
Mahmoud Farouk Hassan, lecturer Of Urology	Contact	+201009152070		Mahmoud12@aun.edu.eg

Overall Officials

Name	Affiliation	Role
Ahmed Mohamed Abdel-Moniem Hassanein, professor of Urology	Assiut University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assiut university		Asyut			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

to put protect privacy of participants

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011470	Prostatic Hyperplasia

Ancestor Terms

ID	Term
D011469	Prostatic Diseases
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided