Short- and Medium-term Safety/Effectiveness Analysis of Low Energy Holmium Laser Enucleation of the Prostate (HoLEP)

1. Overview of the study Research design: prospective, single-arm blind randomized control study, non-inferiority study Study Period: 12 months since IRB approval date Subject: Patients with benign prostatic hyperplasia Number of study subjects: 90 Vulnerable Subjects: None
2. Background and purpose of the study

1. Research background

1. Overview and main symptoms of prostatic hyperplasia (BPH)

-The prostate is a male reproductive organ located in the lower bladder. Benign prostatic hyperplasia (BPH) causes lower urinary tract symptoms (LUTS) due to bladder outlet obstruction.

• The prevalence of prostatic hyperplasia is known to reach 37% in the 50s, 49% in the 60s, and 70% in the 70s; a disease with a very high incidence in long-aged men.
• BPH is a disease directly related to the quality of life that interferes with the patient's social life, sexual life, and daily life. If it persists for a long time, it may cause bladder stones, hematuria, and even renal dysfunction, so timely treatment is absolutely necessary.

2. Surgical Treatment of BPH

-Surgical treatment is recommended for an enlarged prostate that is not treated with drugs, and transurethral surgery using an endoscope is recommended for standard surgery for an enlarged prostate.

• Transurethral surgery for BPH varies from traditional transurethral resection of the prostate (TURP) to holmium laser enucleation of the prostate (HoLEP).
• HoLEP has a sharp increase in the number of surgeries worldwide due to its low recurrence rate, high efficiency, and high patient satisfaction;
• Since its first introduction in 2008 in Korea, the number and rate of surgeries have been steadily increasing. The total number of surgery for BPH is equivalent to about 10,000 cases per year. TUR-P and KTP laser surgery are on a decreasing trend, while HoLEP is on an increasing trend.

3. The importance of HoLEP