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Compares treatment options for Prostatic Hyperplasia With Urinary Obstruction
Official title Green LEP vs ThuLEP in Management of Marked Enlarged Prostate
ClinicalTrials.gov ID: NCT03305861
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 80, men only
You may be able to join 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...
- ASA (American society of anaesthesiologists) score ≤3.
You likely can't join 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...
- Patient has a disorder of the coagulation cascade (e.g., liver cell failure) or disorders that affect platelet count or function (e.g., von...
- Patient is unable to discontinue anticoagulant and antiplatelet therapy preoperatively (3-5 d) except for low-dose aspirin (e.g., 100 mg).
See the full eligibility criteria
- 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
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Al Mansurah, Dakahlia Governorate, Egypt
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 40 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Al Mansurah, Dakahlia Governorate, Egypt. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.