NCT04471155

Brief Summary

comparison of holmium laser enucleation prostatectomy and open prostatectomy regarding safety and efficacy in men with prostate larger than 80 grams

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 15, 2020

Completed
Last Updated

July 15, 2020

Status Verified

July 1, 2020

Enrollment Period

2 years

First QC Date

July 9, 2020

Last Update Submit

July 13, 2020

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (3)

  • efficacy by measuring maximum urinary flow rate in millilitre per second

    change of maximum urinary flow rate in mililiter per second pre and post opeartive

    1 year

  • efficacy in american urological association symptom score

    change of american urological association symptom score pre and post operative by scale from 1 to 35

    1 year

  • efficacy of evacuation by measuring post-voiding residual urine volume in millilitre

    change of post-voiding residual urine volume in millilitre

    1 year

Secondary Outcomes (1)

  • safety by doing blood picture to asses hemoglobin drop

    immediate post-operative

Study Arms (2)

Holep

ACTIVE COMPARATOR

patient underwent laser prostatectomy

Procedure: Holep

open prostatectomy

ACTIVE COMPARATOR

patient underwent open prostatectomy

Procedure: Holep

Interventions

HolepPROCEDURE

laser enucleation of the gland versus open enucleation

Also known as: open prostatectomy
Holepopen prostatectomy

Eligibility Criteria

Age55 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsonly males have prostate
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Urological Association Symptom Score of eight or higher,
  • Maximum urinary flow rate of 10ml/s or less,
  • Post void residual urine volume of 50 ml or more,
  • And a total prostate volume of 80 ml or more in transrectal ultrasound (TRUS).

You may not qualify if:

  • A previous prostate or urethral surgery
  • And non-BPH related voiding disorders
  • Prostate cancer patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohamed Alnoomani

Cairo, Cairo Governorate, Egypt

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
mohamed nabil alnoomani, assistant lecturer of urology

Study Record Dates

First Submitted

July 9, 2020

First Posted

July 15, 2020

Study Start

April 1, 2018

Primary Completion

April 1, 2020

Study Completion

April 22, 2020

Last Updated

July 15, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)