Comparative Study Between Safety and Effectiveness of Hig... | NCT05678452

Studies
Comparative Study Between Safety and Effectiveness of High Versus Low Power HOLEP

NCT05678452

Sponsor

Al-Azhar University

Status

Recruiting

Last Update Posted

Aug 15, 2024Actual

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Benign Prostatic Hyperplasia

Interventions

HOLEP for treating BPH

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

Aug 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2022Actual

Primary Completion Date

Jun 1, 2025Estimated

Completion Date

Sep 1, 2025Estimated

First Submitted Date

Dec 24, 2022

First Submission Date that Met QC Criteria

Jan 9, 2023

First Posted Date

Jan 10, 2023Actual

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

Aug 13, 2024

Last Update Posted Date

Aug 15, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Holmium laser enucleation (HOLEP) has became a standard of treatment of large prostates that indicates surgery. HOLEP is widely used nowadays. Many settings are used but no optimal setting was world wide adopted. The aim of this trial is to assess the Low-power Holmium laser enucleation of the prostate (LP-HoLEP)and compare to high-power (HP-HoLEP) for enucleation efficiency pertaining to the advantages of lower cost and minimal postoperative dysuria, storage symptoms, and negative sexual impact.

Detailed Description

Not provided

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

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LP-HoLEP	Active Comparator	2J/25Hz setting	Procedure: HOLEP for treating BPH
HP-HoLEP.	Active Comparator	2J/50Hz setting	Procedure: HOLEP for treating BPH

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HOLEP for treating BPH	Procedure	HoLEP will be performed using 100W Versapulse, Luminis Inc., with 2J/25Hz for LP-HoLEP and 2J/50Hz for HP-HoLEP.	HP-HoLEP. LP-HoLEP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Enucleation Efficiency	Enucleated weight/min will be evaluated.	3 hours

Secondary Outcomes

Measure	Description	Time Frame
Dysuria will be assessed by dysuria visual analog scale	burning micturation after the procedure. Dysuria will be assessed by dysuria visual analog scale	2 weeks
The complications of both techniques

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

large prostate indicated for surgical intervention.

Exclusion Criteria:

prostate cancer
recurrent adenomas
associated neurologic factors that may affect outcomes (e.g., neurogenic bladder)

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mohamed F Salman, MD	Contact	+201111788996		prof_mohamed_fawzy@yahoo.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Urology department - AlAzhar university	Recruiting	Cairo			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

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