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

Sponsor

Mansoura University (Other)

Overall Status

Completed

CT.gov ID

NCT03916536

Collaborator

(none)

155

Enrollment

Location

Arms

24.9

Actual Duration (Months)

6.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Hypertrophy Holmium Laser Thulium Laser Bipolar Diathermy Prostate Enucleation	Procedure: Holmium Laser Procedure: Thulium Laser Procedure: Bipolar diathermy	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

155 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Feb 1, 2019

Actual Primary Completion Date :

Mar 1, 2021

Actual Study Completion Date :

Mar 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Holmium Laser holmium laser enucleation of the prosteate	Procedure: Holmium Laser Holmium laser enucleation of large sized prostate Other Names: HoLEP
Active Comparator: Thulium Laser Thulium laser enucleation of the prosteate	Procedure: Thulium Laser Thulium laser enucleation of large sized prostate Other Names: ThuLEP
Active Comparator: Bipolar Enucleation Bipolar enucleation of the prosteate	Procedure: Bipolar diathermy Bipolar enucleation of large sized prostate Other Names: Bipolar enucleation

Arm

Intervention/Treatment

Active Comparator: Holmium Laser

holmium laser enucleation of the prosteate

Procedure: Holmium Laser

Holmium laser enucleation of large sized prostate

Other Names:

HoLEP

Active Comparator: Thulium Laser

Thulium laser enucleation of the prosteate

Procedure: Thulium Laser

Thulium laser enucleation of large sized prostate

Other Names:

ThuLEP

Active Comparator: Bipolar Enucleation

Bipolar enucleation of the prosteate

Procedure: Bipolar diathermy

Bipolar enucleation of large sized prostate

Other Names:

Bipolar enucleation

Outcome Measures

Primary Outcome Measures

urinary functional outcomes using uroflowmetry [2 years]
assessed by maximum flow rate (Q-max) measured using uroflowmetry by ml/sec, better outcome above 15ml/sec

Secondary Outcome Measures

patient symptoms [2 years]
assessed by international prostate symptoms score (IPSS) questionnaire, better outcome score below 9
perioperative complications [2 years]
assessed by clavien dindo score

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

Male

Accepts 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.