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Holmium Laser Versus Thulium Laser Versus Bipolar Enucleation of the Prostate.

Primary Purpose

Prostate Hypertrophy, Holmium Laser, Thulium Laser

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Holmium Laser

Thulium Laser

Bipolar diathermy

About this trial

This is an interventional treatment trial for Prostate Hypertrophy focused on measuring Holmium Laser, Thulium Laser, Bipolar diathermy, prostate enucleation

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.

Sites / Locations

Urology and Nephrology Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Holmium Laser

Thulium Laser

Bipolar Enucleation

Arm Description

holmium laser enucleation of the prosteate

Thulium laser enucleation of the prosteate

Bipolar enucleation of the prosteate

Outcomes

Primary Outcome Measures

urinary functional outcomes using uroflowmetry

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

Secondary Outcome Measures

patient symptoms

assessed by international prostate symptoms score (IPSS) questionnaire, better outcome score below 9

perioperative complications

assessed by clavien dindo score

Full Information

NCT ID

NCT03916536

First Posted

April 13, 2019

Last Updated

September 18, 2021

Sponsor

Mansoura University

1. Study Identification

Unique Protocol Identification Number

NCT03916536

Brief Title

Holmium Laser Versus Thulium Laser Versus Bipolar Enucleation of the Prostate.

Official Title

Holmium Laser Versus Thulium Laser Versus Bipolar Enucleation of the Prostate for Treatment of Large Sized Benign Prostatic Enlargement. A Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

February 1, 2019 (Actual)

Primary Completion Date

March 1, 2021 (Actual)

Study Completion Date

March 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Hypertrophy, Holmium Laser, Thulium Laser, Bipolar Diathermy, Prostate Enucleation

Keywords

Holmium Laser, Thulium Laser, Bipolar diathermy, prostate enucleation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

155 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Holmium Laser

Arm Type

Active Comparator

Arm Description

holmium laser enucleation of the prosteate

Arm Title

Thulium Laser

Arm Type

Active Comparator

Arm Description

Thulium laser enucleation of the prosteate

Arm Title

Bipolar Enucleation

Arm Type

Active Comparator

Arm Description

Bipolar enucleation of the prosteate

Intervention Type

Procedure

Intervention Name(s)

Holmium Laser

Other Intervention Name(s)

HoLEP

Intervention Description

Holmium laser enucleation of large sized prostate

Intervention Type

Procedure

Intervention Name(s)

Thulium Laser

Other Intervention Name(s)

ThuLEP

Intervention Description

Thulium laser enucleation of large sized prostate

Intervention Type

Procedure

Intervention Name(s)

Bipolar diathermy

Other Intervention Name(s)

Bipolar enucleation

Intervention Description

Bipolar enucleation of large sized prostate

Primary Outcome Measure Information:

Title

urinary functional outcomes using uroflowmetry

Description

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

Time Frame

2 years

Secondary Outcome Measure Information:

Title

patient symptoms

Description

assessed by international prostate symptoms score (IPSS) questionnaire, better outcome score below 9

Time Frame

2 years

Title

perioperative complications

Description

assessed by clavien dindo score

Time Frame

2 years

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

male

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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.

Facility Information:

Facility Name

Urology and Nephrology Center

City

Mansoura

State/Province

Dakahlia

ZIP/Postal Code

35516

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Holmium Laser Versus Thulium Laser Versus Bipolar Enucleation of the Prostate.

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