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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03916536
Other study ID # Prostate Enucleation
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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