Ignite Creation Date:
2024-05-06 @ 9:44 AM
Last Modification Date:
2024-10-26 @ 12:19 PM
Study NCT ID:
NCT03062111
Status:
TERMINATED
Last Update Posted:
2021-02-03
First Post:
2017-01-30
Brief Title:
Laser Enucleation of Prostate LEP Versus Transurethral Resection of Prostate TURP
Sponsor:
Boston University
Organization:
Boston University
Study Overview
Official Title:
Laser Enucleation of Prostate LEP Versus Transurethral Resection of Prostate TURP a Prospective Study Comparing Outcomes
Status:
TERMINATED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was stopped due to low enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Benign prostatic hyperplasia BPH refers to the proliferation of smooth muscle and epithelial cells of the prostate gland The enlarged gland has the potential to result in lower urinary tract symptoms LUTS secondary to either bladder outlet obstruction or increased muscle tone and resistance or both
For decades transurethral resection of the prostate TURP has been the gold standard for treatment of symptomatic BPH that is refractory to nonoperative management This is a surgical intervention aimed to reduce the size of the prostate gland However over the past fifteen years many alternative therapies have been introduced including laser enucleation of the prostate LEP LEP has numerous advantages including decreased blood loss and length of hospital stay as well as increased effectiveness and safety for large prostate gland sizes 80g
For decades transurethral resection of the prostate TURP has been the gold standard for treatment of symptomatic BPH that is refractory to nonoperative management This is a surgical intervention aimed to reduce the size of the prostate gland However over the past fifteen years many alternative therapies have been introduced including laser enucleation of the prostate LEP LEP has numerous advantages including decreased blood loss and length of hospital stay as well as increased effectiveness and safety for large prostate gland sizes 80g
Detailed Description:
The purpose of this study is to compare the effectiveness of TURP to LEP using the ProTouch laser technology While TURP has historically been the gold standard LEP has become more widespread and is arguably a safer and more effective therapy for the patient TURP is still widely performed because it is a traditional therapy with decades of data to support its efficacy despite higher volume of blood loss and risk for TUR syndrome In comparison there is some data demonstrating that Holmium Laser Enucleation of the Prostate can have similar efficacy but may have longer operative times The ProTouch laser is comparable to the Holmium laser but additionally provides improved hemostasis and tissue vaporization There is little to no data comparing LEP with the ProTouch laser to TURP This study will directly compare the efficacy of these two treatment methods by enrolling eligible subjects and comparing outcomes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None