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

Prostate Hypertrophy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03916536
• Other study ID #: Prostate Enucleation
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: March 1, 2021

Study information

• Verified date: September 2021
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: March 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar Diathermy
• Holmium Laser
• Hyperthermia
• Hypertrophy
• Prostate Enucleation
• Prostate Hypertrophy
• Prostatic Hyperplasia
• Thulium Laser

Intervention

Procedure:
• Holmium Laser
Holmium laser enucleation of large sized prostate
• Thulium Laser
Thulium laser enucleation of large sized prostate
• Bipolar diathermy
Bipolar enucleation of large sized prostate

Locations

Country	Name	City	State
Egypt	Urology and Nephrology Center	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	patient symptoms	assessed by international prostate symptoms score (IPSS) questionnaire, better outcome score below 9	2 years
Secondary	perioperative complications	assessed by clavien dindo score	2 years