NCT03916536

Brief Summary

Because of the diversity of the studies and deficiency of those comparing various techniques of EEP for treatment of LUTs secondary to BPO in patients with large sized prostate, we aim in this study at testing the non-inferiority of PKEP and ThuLEP to HoLEP in relieving LUTs secondary to BPO in patients prostate size \>80ml. Our hypothesis is to present an evidence that enucleation is a technique rather than a power dependent procedure through a RCT.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
155

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2019

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

February 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 16, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

September 21, 2021

Status Verified

September 1, 2021

Enrollment Period

2.1 years

First QC Date

April 13, 2019

Last Update Submit

September 18, 2021

Conditions

Prostate HypertrophyHolmium LaserThulium LaserBipolar DiathermyProstate Enucleation

Keywords

Holmium LaserThulium LaserBipolar diathermyprostate enucleation

Outcome Measures

Primary Outcomes (1)

  • urinary functional outcomes using uroflowmetry

    assessed by maximum flow rate (Q-max) measured using uroflowmetry by ml/sec, better outcome above 15ml/sec

    2 years

Secondary Outcomes (2)

  • patient symptoms

    2 years

  • perioperative complications

    2 years

Study Arms (3)

Holmium Laser

ACTIVE COMPARATOR

holmium laser enucleation of the prosteate

Procedure: Holmium Laser

Thulium Laser

ACTIVE COMPARATOR

Thulium laser enucleation of the prosteate

Procedure: Thulium Laser

Bipolar Enucleation

ACTIVE COMPARATOR

Bipolar enucleation of the prosteate

Procedure: Bipolar diathermy

Interventions

Holmium LaserPROCEDURE

Holmium laser enucleation of large sized prostate

Also known as: HoLEP
Holmium Laser
Thulium LaserPROCEDURE

Thulium laser enucleation of large sized prostate

Also known as: ThuLEP
Thulium Laser
Bipolar diathermyPROCEDURE

Bipolar enucleation of large sized prostate

Also known as: Bipolar enucleation
Bipolar Enucleation

Eligibility Criteria

Age50 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients' age \>50 years
  • Lower urinary tract symptoms LUTS secondary benigh prostatic obstruction BPO who failed medical treatment
  • International prostate symptom scores (IPSS) \>15 and bother score quality of life (QOL) \> 3 (according to IPSS question 8)
  • Maximum urinary flow rate (Q max) \<15 ml/sec with at least 150 ml voided volume or cases with acute urine retention secondary to BPO who failed trial of voiding on medical treatment.
  • Transrectal ultrasound TRUS estimated total prostate size 80-250cc

You may not qualify if:

  • Patient with neurological disorder which might affect bladder function as cerebrovascular stroke, Parkinson disease
  • Active urinary tract infection (positive urine culture) till treatment
  • Presence of bladder cancer (within the last 2 years)
  • Known prostate cancer patients will be excluded preoperatively on the basis of digital rectal examination, prostate specific antigen level, and TRUS imaging followed by prostate biopsies if necessary.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology and Nephrology Center

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

Related Publications (1)

  • Shoma AM, Ghobrial FK, El-Tabey N, El-Hefnawy AS, El-Kappany HA. A randomized trial of holmium laser vs thulium laser vs bipolar enucleation of large prostate glands. BJU Int. 2023 Dec;132(6):686-695. doi: 10.1111/bju.16174. Epub 2023 Sep 28.

    PMID: 37667842DERIVED

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Lasers, Solid-State

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

LasersOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

April 13, 2019

First Posted

April 16, 2019

Study Start

February 1, 2019

Primary Completion

March 1, 2021

Study Completion

March 1, 2021

Last Updated

September 21, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)