Holmium laser enucleation of prostate (HoLEP): HoLEP is a widespread and minimally invasive surgical method to treat LUTS caused by BPO. En-bloc or tri-lobar technique will be performed according to the surgeon's preference during the procedure.
Study summary
The goal of this observational study is to determine whether the rate of prostate tissue removed during surgery relative to the preoperative total prostate volume (referred to as the "enucleation ratio") predicts symptomatic improvement 3 months after HoLEP. The main question it aims to answer is:
\- What is the minimum enucleation ratio required to achieve clinically important symptomatic improvement? (Symptomatic improvement is referred to as a threshold of having an International Prostate Symptom Score (IPSS) lower than 8 points, which is determined by the American Urological Association (AUA) and European Association of Urology(EAU)).
Eligibility
Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Men aged 18 years pr older who are planned to undergo HoLEP.
* Participants who are willing to give informed consent.
* Participants who have moderate to severe LUTS (referring to IPSS score 8 points or more).
* No history of previous prostate or urethral surgery.
Exclusion Criteria:
* Unwillingness to provide informed consent.
* Unwillingness to provide contact information or unreachability during follow-up periods.
* Incidental diagnosis of a urogenital malignancy requiring primary treatment after enrollment (e.g., bladder tumor, renal cell carcinoma, testicular tumor).
Primary outcome measure(s)
Achievement of mild symptom category (IPSS < 8) at 3 months after HoLEP — 3 months after HoLEP The International Prostate Symptom Score (IPSS) is a validated questionnaire for lower urinary tract symptoms (LUTS).
An IPSS score of 1-7 indicates mild LUTS, 8-19 moderate, and 20-35 severe LUTS, according to both the AUA and the EAU.
Achievement of mild LUTS (IPSS \< 8) is widely accepted as a satisfactory surgical outcome. Therefore, the primary outcome was set as binary (IPSS \< 8 or otherwise).
3 months as a postoperative period is preferred because relief of irritative symptoms requires time, and the 3-month timepoint is widely adopted in the HoLEP literature as the standard assessment period for functional outcomes, allowing sufficient recovery from transient postoperative irritative symptoms while reflecting stable surgical results.
Trial sites (1)
Facility
City
Region
Status
Ondokuz Mayis University, Faculty of Medicine, Department of Urology
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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