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

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).

Study Overview

• Status: Terminated
• Conditions: Benign Prostatic Hyperplasia
• Intervention / Treatment: Procedure: ProTouch Laser Enucleation of Prostate (LEP); Procedure: Transurethral Resection of Prostate (TURP)

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 Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: ProTouch Laser Enucleation of Prostate; The intervention for this group is that the patient will undergo endoscopic ProTouch Laser Enucleation of Prostate (LEP).The laser is used to enucleate large pieces of prostatic tissue which is followed by further ablation of the tissue so that no fragments are left in the bladder	Procedure: ProTouch 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.
ACTIVE_COMPARATOR: Transurethral Resection of Prostate; The intervention for this group that the patient will undergo endoscopic Transurethral Resection of Prostate (TURP) using bipolar cautery. The prostate is essentially shaved down using sequential cuts and cautery.	Procedure: Transurethral 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Urinary Flow Rate	Velocity (in cc/sec) of the urine flow	From time of randomization and ultimately at 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life score	Survey to determine how satisfied the patient is with urination	From time of randomization and ultimately at 24 months
Blood loss	Amount of blood loss during surgery.	During surgery (full length of operative time)
Catheter time	the amount of time a catheter must stay in place postoperatively	From time of surgery to up to 3 weeks after surgery.
Post void residual	Amount of urine remaining in the bladder after voiding	From time of randomization and ultimately at 24 months
Sexual Health Inventory for Men (SHIM)	Survey to assess baseline sexual function and whether this is affected by intervention type	From time of randomization and ultimately at 24 months

Collaborators and Investigators

• Sponsor: Boston University
• Investigators: Principal Investigator: Shaun Wason, MD, Boston University

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 23, 2017
• Primary Completion (ACTUAL): January 15, 2021
• Study Completion (ACTUAL): January 15, 2021

Study Registration Dates

• First Submitted: January 30, 2017
• First Submitted That Met QC Criteria: February 20, 2017
• First Posted (ACTUAL): February 23, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 3, 2021
• Last Update Submitted That Met QC Criteria: January 31, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Laser Enucleation of Prostate (LEP); Transurethral Resection of Prostate (TURP)
• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: H-36011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No