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

Sponsor
Al-Azhar University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05678452
Collaborator
(none)
200
Enrollment
1
Location
2
Arms
32
Anticipated Duration (Months)
6.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: HOLEP for treating BPH
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
HoLEP will be performed using 100W Versapulse, Luminis Inc., with 2J/25Hz for LP-HoLEP and 2J/50Hz for HP-HoLEP.HoLEP will be performed using 100W Versapulse, Luminis Inc., with 2J/25Hz for LP-HoLEP and 2J/50Hz for HP-HoLEP.
Masking:
None (Open Label)
Masking Description:
double blind
Primary Purpose:
Treatment
Official Title:
Comparative Study Between Safety and Efficacy of High Versus Low Power HOLEP in Enucleation of the Prostate; Prospective Randomized Double Blind Trial
Actual Study Start Date :
Jan 1, 2022
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: LP-HoLEP

2J/25Hz setting

Procedure: HOLEP for treating BPH
HoLEP will be performed using 100W Versapulse, Luminis Inc., with 2J/25Hz for LP-HoLEP and 2J/50Hz for HP-HoLEP.
Active Comparator: HP-HoLEP.

2J/50Hz setting

Procedure: HOLEP for treating BPH
HoLEP will be performed using 100W Versapulse, Luminis Inc., with 2J/25Hz for LP-HoLEP and 2J/50Hz for HP-HoLEP.

Outcome Measures

Primary Outcome Measures

  1. Enucleation Efficiency [3 hours]

    Enucleated weight/min will be evaluated.

Secondary Outcome Measures

  1. Dysuria will be assessed by dysuria visual analog scale [2 weeks]

    burning micturation after the procedure. Dysuria will be assessed by dysuria visual analog scale

  2. The complications of both techniques [3 months]

    The complications will be classified according to the modified Clavien classification system.

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Urology department - AlAzhar university Cairo Egypt

Sponsors and Collaborators

  • Al-Azhar University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mohamed Fawzy Abd Elfattah Salman, Director, Al-Azhar University
ClinicalTrials.gov Identifier:
NCT05678452
Other Study ID Numbers:
  • low and high power HOLEP
First Posted:
Jan 10, 2023
Last Update Posted:
Jan 10, 2023
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mohamed Fawzy Abd Elfattah Salman, Director, Al-Azhar University
HOLEP, Enucleation, Prostate
Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia

Study Results

No Results Posted as of Jan 10, 2023