Status:
ACTIVE_NOT_RECRUITING
Top-Down Holmium Laser Enucleation of the Prostate (HoLEP) vs the Traditional HoLEP for Treatment of Benign Prostatic Hyperplasia (BPH)
Lead Sponsor:
Thunder Bay Regional Health Research Institute
Conditions:
Benign Prostatic Hyperplasia
Lower Urinary Tract Symptoms
Eligibility:
MALE
50+ years
Phase:
NA
Brief Summary
Benign prostatic hyperplasia (BPH), the non-malignant enlargement of the prostate gland, places pressure on the urethra and causes urination difficulties and bladder problems. Lower Urinary Tract Symp...
Detailed Description
Benign prostatic hyperplasia (BPH), the non-malignant enlargement of the prostate gland, places pressure on the urethra and causes urination difficulties and bladder problems. Lower Urinary Tract Symp...
Eligibility Criteria
Inclusion
- Males over 50 years of age at the time of enrollment
- Referred to urology for refractory LUTS secondary to BPH
- Failed medical (non-surgical) treatment
- Prostate size on preoperative TRUS of \> 80 ml
- IPSS \>15, QOL score ≥3 and Qmax \<15 ml/sec
- Written informed consent to participate in the study
- Ability to comply with the requirements of the study procedures
Exclusion
- Previous surgical treatment for BPH
- Presence of bladder stones
- History of prostate cancer
- Prostate size \< 80 mL
- History of urethral stenosis or its management
- Known or suspected neurogenic bladder
- Participants with active urinary tract infection until appropriately treated
- Participants with preexisting conditions, which, in the opinion of the investigator, interfere with the conduct of the study
- Participants who lack the capacity, or cannot speak English, in order to provide free and informed written consent
Key Trial Info
Start Date :
October 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2026
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT04391114
Start Date
October 15 2019
End Date
December 31 2026
Last Update
April 10 2025
Active Locations (1)
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1
Thunder Bay Regional Health Sciences Centre/Thunder Bay Regional Health Research Institute
Thunder Bay, Ontario, Canada, P7B6V4