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

NCT ID: NCT03062111

Last Updated: 2021-02-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-23
• Study Completion Date: 2021-01-15

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.

Conditions

Benign Prostatic Hyperplasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

ProTouch Laser Enucleation of Prostate (LEP)

Intervention Type: PROCEDURE

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.

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.

Group Type: ACTIVE_COMPARATOR

Transurethral Resection of Prostate (TURP)

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boston University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shaun Wason, MD

Role: PRINCIPAL_INVESTIGATOR

Boston University

Locations

Boston University Medical Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

H-36011

Identifier Type: -

Identifier Source: org_study_id