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)).
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.
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).
Adult males with moderate to severe lower urinary tract symptoms (LUTS) secondary to benign prostatic obstruction (BPO) who are scheduled to undergo holmium laser enucleation of the prostate (HoLEP) at participating urology centers across multiple institutions.
Cohort
Prospective
Holmium laser enucleation of prostate (HoLEP)
Procedure/SurgeryHoLEP 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.
Achievement of mild symptom category (IPSS < 8) at 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.
QoL score reduction of at least 1 point from the baseline at 3 months after HoLEP
The Quality of Life (QoL) score is a single validated question included in the IPSS questionnaire that assesses how much lower urinary tract symptoms affect a patient's daily life, scored from 0 (delighted) to 6 (terrible). 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.
Qmax > 15 mL/s achievement rate at 3 months after HoLEP
Maximum urinary flow rate (Qmax) is an objective measure of voiding efficiency assessed by uroflowmetry. A Qmax of 15 mL/s is widely accepted as the threshold distinguishing normal from impaired voiding, as referenced in EAU guidelines for non-neurogenic male LUTS. 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.
Ratio of high grade complications (Clavien-Dindo grade III or higher) within 1 month after HoLEP
In large HoLEP series, 30-day postoperative complications have been consistently reported using the Clavien-Dindo classification.
Ratio of stress urinary incontinence at 3 months after HoLEP
Stress urinary incontinence, whether transient or permanent, is a well-recognized complication of HoLEP, and its absence at 3 months postoperatively is among the criteria for Trifecta achievement as defined in the literature.
PVR-R change 3 months after HoLEP
Post-void residual ratio (PVR-R) is calculated by dividing post-void residual volume by total bladder capacity, both obtained from uroflowmetry. Although PVR-R is referenced in the EAU guidelines on urinary incontinence, it has not yet been established as a standard outcome measure in the BPH surgery literature. Nevertheless, expressing post-void residual as a ratio relative to total bladder capacity may offer a more individualized and reproducible measure compared to absolute volume alone, and its exploratory assessment following HoLEP may contribute to future standardization of voiding outcomes.
tPSA change 3 months after HoLEP
Total prostate-specific antigen (tPSA) is expected to decline following HoLEP due to the removal of adenoma tissue, and its postoperative change may serve as an indirect indicator of enucleation completeness. Furthermore, as preoperative tPSA correlates with prostate volume - from which the enucleation ratio is derived - it is considered a potential confounder in the primary analysis and will be assessed exploratorily to better understand its relationship with both the predictor and the primary outcome.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
