Green LEP vs ThuLEP in Management of Marked Enlarged Prostate

NCT03305861 | Recruiting DMC

• 1 other identifier: MD/17.02.26
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

In this study the investigators aim to test TGreenlight (532-nm) laser Photoselective Enucleation of the Prostate (Green LEP) using (XPS) 180W system ) vs Thulium Laser 200 W Enucleation of the Prostate (ThuLEP) in reduction of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) in a randomized controlled trial. Furthermore, all peri-operative parameters, urinary flow parameters, prostate size changes and complications associated with the procedures will be compared.

Conditions

Prostatic Hyperplasia With Urinary Obstruction

Keywords

Thulium Laser Enucleation of the Prostate (ThuLEP); Greenlight Laser Enucleation of the Prostate (Green LEP)

Outcome Measures

Primary Outcomes (2)

• voiding and storage symptoms improvement

  International Prostate Symptom Score (I-PSS)

  6 months

• sexual function changes

  International Index of Erectile Function Questionnaire (IIEF)

  6 months

Secondary Outcomes (2)

• Operative time

  6 months

• Postoperative complication

  12 months

Study Arms (2)

ThuLEP

EXPERIMENTAL

Thulium laser enucleation of prostate

Procedure: ThuLEP

Green LEP

EXPERIMENTAL

Greenlight laser enucleation of prostate

Procedure: Green LEP

Interventions

ThuLEP PROCEDURE

Thulium laser enucleation of prostate

ThuLEP

Green LEP PROCEDURE

Greenlight laser enucleation of prostate

Green LEP

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients' age ≥ 40 years
• LUTS secondary to BOO due to BPH who failed medical treatment
• International prostate symptom scores (IPSS) \>15 and bother score (QOL) ≥ 3 (according to IPSS question 8)
• Peak urinary flow rate (Qmax) \<15 ml/sec with at least 125 ml voided volume or Patients with acute urine retention secondary to BPH who failed trial of voiding on medical treatment.
• ASA (American society of anaesthesiologists) score ≤3.
• TRUS prostate size \> /= 80 ml

You may not qualify if:

• Patient with neurological disorder which might affect bladder function as cerebrovascular stroke, Parkinson disease
• Active urinary tract infection,
• Presence of active 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.
• Patient has a disorder of the coagulation cascade (e.g., liver cell failure) or disorders that affect platelet count or function (e.g., von Willebrand disease) that would put the subject at risk for intraoperative or postoperative bleeding.
• Patient is unable to discontinue anticoagulant and antiplatelet therapy preoperatively (3-5 d) except for low-dose aspirin (e.g., 100 mg).
• Patient has had an acute myocardial infarction or open-heart surgery \<180 days prior to the date of informed consent.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Urology and Nephrology Center

Al Mansurah, Dakahlia Governorate, Egypt

RECRUITING

Central Study Contacts

Mahmoud Nabil Laymon, MD

CONTACT

00201002275698; dr_mahmoudlaymon@yahoo.com

Adel M Nabeeh, Professor

CONTACT

0020100196665; adel_nabeeh51@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 22, 2017
• First Posted: October 10, 2017
• Study Start: April 1, 2017
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: October 30, 2024

Record last verified: 2024-10

Locations

EG (1)