About this trial
Holmium laser enucleation of the prostate (HoLEP) is a surgical treatment option for men experiencing bothersome lower urinary tract symptoms due to an enlarged prostate. Researchers predict that specific participant or operator-dependent conditions before or during HoLEP may influence the trifecta outcome, based on similar studies. Therefore, the aim of this study is to understand what these conditions are. Trifecta success indicates a high-quality surgery based on three essential criteria: the treatment's effectiveness, ease of recovery, and the absence of serious side effects. In this study, trifecta is defined as relief from bothersome symptoms validated by international symptom score questionnaires, no urinary incontinence, and no serious events occurring within three months after HoLEP.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All male patients aged ≥ 40 years who are candidates for surgical treatment for BPO.
Ability to provide informed consent, when required.
Disqualifiers
Clinically proven active condition(s) that require another intervention other than BPO surgery, such as lower urinary tract malignancy, urethral stricture, or neurogenic lower urinary tract symptoms.
History of previous surgery for BPO, urethral stricture, or prostate cancer.
Incomplete baseline or procedural data.
Trial design
Single group
Treatments tested in this trial
Transurethral Holmium Laser Enuclation of the Prostate
Procedure/SurgeryHoLEP, En-bloc or tri-lobar technique.
Treatment groups
Trial outcomes
Primary outcomes
Trifecta achievement three months after HoLEP
Achievement of all three of the following criteria, three months after HoLEP: 1. At least a 30% reduction in International Prostate Symptom Score (IPSS) 2. Absence of major complications (no Clavien-Dindo grade \> II), 3. No urinary incontinence
Secondary outcomes
Length of Hospital Stay After the Intervention
Duration of hospitalization following the intervention. Unit: days
Change in peak urinary flow rate (Qmax)
Difference in maximum urinary flow rate measured by uroflowmetry compared to baseline. Unit: mL/s
Other outcomes
Bladder Voiding Efficiency (BVE)
Bladder voiding efficiency, defined as the ratio of voided volume to total bladder capacity. Ratio (unitless)
Enucleation-Volume Ratio
Enucleation-volume ratio, defined as the ratio of enucleated adenoma weight to pre-operatively measured prostate volume. Ratio (unitless).
Sponsors and contacts
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