BPH With Symptomatic Lower Urinary Tract Symptoms, BPH With Urinary Obstruction
Conditions
Keywords
BPH, Enlarged prostate, Thulio laser, Prostate enucleation, male urinary retention
Brief summary
Many consider laser enucleation of the prostate the new 'gold standard' for the surgical treatment of benign prostatic hyperplasia (BPH) due to its excellent outcomes, high success rates, and long-term efficacy. Holmium laser enucleation of the prostate (HoLEP) was the earliest form of prostate enucleation and is recommended by the American Urological Association (AUA), along with thulium laser enucleation of the prostate (ThuLEP), as size-independent techniques for the management of BPH with fewer complications than transurethral resection of the prostate (TURP). Further development of laser technology has additionally led to enucleation using pulsed-modulated (e.g. Virtual Basket™ mode or MOSES™ mode) holmium lasers as well as the thulium fiber laser.
Detailed description
Study Design This is a prospective randomized study to evaluate the differences in outcomes comparing the existing laser to a new laser among patients undergoing HoLEP. Patients will be evaluated prior to the procedure and at one follow-up time point. Patients will be randomized in equal numbers to each group. The primary outcome will be non-inferiority in hemostasis timing. Several secondary outcomes will be evaluated including enucleation time, active laser time, morcellation time, prostate volume, change in hemoglobin, applied total laser energy, enucleation efficacy (g/min), IPSS (International Prostate Symptom Score), QoL (Quality of Life), uroflowmetry, PVR (post-void residual), duration of catheterization.
Interventions
DEVICEholmium laser
Prostate enucleation will holmium laser (control)
DEVICEpulsed thulium laser
experimental group - pulsed thulium laser prostate enucleation
Sponsors
Smita De
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Understand and voluntarily sign an informed consent form. * Patients must be males with a prostate, at least 18 years of age * No prior prostate surgery
Exclusion criteria
* Unable/refuse to provide informed consent * Prior prostate surgery * Bladder stones that requiring lasering (small stone that can be removed whole is ok) * Unable to hold anticoagulants or antiplatelets per standard protocols for surgery and up to 1 week postop.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemostasis time | During surgery | time required to get adequate hemostasis intraoperatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood Loss | During surgery | Estimated blood loss (mL) |
| Operative parameters | During surgery | Enucleation time (minutes) |
| Laser parameters | During surgery | Laser time (minutes) |
| Subjective laser performance | During surgery | Surgeon estimation of collateral tissue injury and overall performance (scale 1 minimum 10 maximum) |
| Perioperative outcomes | 0-5 days after surgey | volume of tissue removed (mL) |
Countries
United States
Contacts
Primary ContactIva Markovic
Backup ContactSmita De, MD, PHD
Outcome results
None listed