Status:
RECRUITING
Green LEP vs ThuLEP in Management of Marked Enlarged Prostate
Lead Sponsor:
Mansoura University
Conditions:
Prostatic Hyperplasia With Urinary Obstruction
Eligibility:
MALE
40-80 years
Phase:
NA
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 Prosta...
Detailed Description
Transurethral resection of the prostate (TURP) and open simple prostatectomy (SP) have been the historical reference-standard procedures for prostates \< 80 g and ≥ 80 to 100 g, respectively, for year...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2024
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT03305861
Start Date
April 1 2017
End Date
November 1 2024
Last Update
October 30 2024
Active Locations (1)
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1
Urology and Nephrology Center
Al Mansurah, Dakahlia Governorate, Egypt