Cleveland Clinic Main
Cleveland, Ohio, 44195, United States
Location status: Recruiting
Location contact
Iva Markovic
CONTACT
Smita De, MD, PhD
CONTACT
NCT Number: NCT07187180
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.
Interested in participating?
Request Info18 year and older
Male
Interventional
Not applicable
Cleveland, Ohio, 44195, United States
Location status: Recruiting
Iva Markovic
CONTACT
Smita De, MD, PhD
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Prostate enucleation will holmium laser (control)
experimental group - pulsed thulium laser prostate enucleation
Time frame: During surgery
time required to get adequate hemostasis intraoperatively
Time frame: During surgery
Estimated blood loss (mL)
Time frame: During surgery
Change in hemoglobin (delta g/dL)
Time frame: During surgery
Enucleation time (minutes)
Time frame: During surgery
morcellation time (minutes)
Time frame: During surgery
enucleation efficiency (mL prostate)
Time frame: During surgery
Laser time (minutes)
Time frame: During surgery
laser energy (joules)
Time frame: During surgery
Fiber burn-back (cm)
Time frame: During surgery
Surgeon estimation of collateral tissue injury and overall performance (scale 1 minimum 10 maximum)
Time frame: 0-5 days after surgey
volume of tissue removed (mL)
Time frame: 0-5 days after surgery
catheter time (hours)
Time frame: 0-5 days after surgery
length of stay (hours)
Time frame: 30 days post op
operative complications
Contact information is provided by the study sponsor or research team.
Iva Markovic
CONTACT
Smita De, MD, PHD
CONTACT
Smita De
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05186740
BPH With Symptomatic Lower Urinary Tract Symptoms, Genital Diseases
Sacramento, California, United States
View Trial DetailsNCT06236802
BPH With Symptomatic Lower Urinary Tract Symptoms, Genital Diseases
Tampa, Florida, United States
View Trial DetailsNCT07680543
BPH With Symptomatic Lower Urinary Tract Symptoms, Genital Diseases
View Trial DetailsNCT05652023
BPH With Urinary Obstruction, Bladder Dysfunction
Rochester, Minnesota, United States
View Trial Details