Clinical trial NCT03062111: Laser Enucleation of Prostate (LEP) Versus Transurethral Resection of Prostate (TURP)
Official title: Laser Enucleation of Prostate (LEP) Versus Transurethral Resection of Prostate (TURP): a Prospective Study Comparing Outcomes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Keywords: Laser Enucleation of Prostate (LEP)
Transurethral Resection of Prostate (TURP)
Lead sponsor: Boston University
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 3
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).

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.

Eligibility criteria: Inclusion Criteria:

* Male
* Age \> 50-80 years
* Prostate gland size 50-100g
* Failure of nonoperative therapy
* IPSS 8+
* FR \<15ml/s
* PVR \<250
* If PVR is 250-400 then pre-operative urodynamics will be indicated
* Language: English, Spanish, Haitian Creole, French, Portuguese
* Willing to randomize

Exclusion Criteria:

* Neurogenic bladder
* PVR \>400ml
* IPSS \<8
* FR \>15ml/Indwelling catheter

  - History of prostate cancer
* History of urethral stricture or vesicourethral anastomotic stricture
* Unable to be placed in lithotomy position
* Unable to undergo general or spinal anesthesia
* Unable to consent
* Untreated or uncorrected coagulopathy

Primary outcomes:
measure: Change in Urinary Flow Rate
timeFrame: From time of randomization and ultimately at 24 months
Secondary outcomes:
measure: Quality of Life score
timeFrame: From time of randomization and ultimately at 24 months
measure: Blood loss
timeFrame: During surgery (full length of operative time)
measure: Catheter time
timeFrame: From time of surgery to up to 3 weeks after surgery.
measure: Post void residual
timeFrame: From time of randomization and ultimately at 24 months
measure: Sexual Health Inventory for Men (SHIM)
timeFrame: From time of randomization and ultimately at 24 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University Medical Center
state: Massachusetts
Study officials:
affiliation: Boston University
name: Shaun Wason, MD
role: PRINCIPAL_INVESTIGATOR
References: