Clinical Trials Directory

Trials / Terminated

TerminatedNCT03062111

Laser Enucleation of Prostate (LEP) Versus Transurethral Resection of Prostate (TURP)

Laser Enucleation of Prostate (LEP) Versus Transurethral Resection of Prostate (TURP): a Prospective Study Comparing Outcomes

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
3 (actual)
Sponsor
Boston University · Academic / Other
Sex
Male
Age
50 Years
Healthy volunteers
Accepted

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).

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREProTouch Laser Enucleation of Prostate (LEP)Laser enucleation of the prostate is a standard form of treatment for BPH used widely. The ProTouch laser is established to be safe and is newer than the holmium laser.
PROCEDURETransurethral Resection of Prostate (TURP)TURP has been considered a gold standard for treatment of BPH in which rigid resectoscopes with bipolar cautery are used to endoscopically resect prostatic tissue.

Timeline

Start date
2017-10-23
Primary completion
2021-01-15
Completion
2021-01-15
First posted
2017-02-23
Last updated
2021-02-03

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03062111. Inclusion in this directory is not an endorsement.