Status:
COMPLETED
High Power Thulium Vaporization vs Transurethral Resection of the Prostate for Treatment of BPH
Lead Sponsor:
Mansoura University
Conditions:
Benign Prostatic Hyperplasia
Eligibility:
MALE
50+ years
Phase:
NA
Brief Summary
the investigators plan to test Thulium laser vaporization using high power ( 200w ) Front fire vaporization compared to standard M-TURP in reduction of LUTS secondary to BPH in a prospective randomize...
Detailed Description
When Lower Urinary Tract Symptoms (LUTS) are refractory to medical therapy and bothersome enough to warrant surgical intervention, transurethral resection of the prostate (TURP) has been the historica...
Eligibility Criteria
Inclusion
- Patients' age ≥50 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 between 30-80 ml
Exclusion
- Patient with neurological disorder which might affect bladder function as cerebrovascular stroke, Parkinson disease
- Active urinary tract infection,
- Presence of active bladder pathology (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 :
May 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03264482
Start Date
May 20 2017
End Date
December 1 2020
Last Update
July 27 2021
Active Locations (1)
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1
Urology and nephrology center
Al Manşūrah, DK, Egypt, 35516