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

NCT03062111 | Terminated

• 1 other identifier: H-36011
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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).

Conditions

Benign Prostatic Hyperplasia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in Urinary Flow Rate

  Velocity (in cc/sec) of the urine flow

  From time of randomization and ultimately at 24 months

Secondary Outcomes (5)

• Quality of Life score

  From time of randomization and ultimately at 24 months

• Blood loss

  During surgery (full length of operative time)

• Catheter time

  From time of surgery to up to 3 weeks after surgery.

• Post void residual

  From time of randomization and ultimately at 24 months

• Sexual Health Inventory for Men (SHIM)

  From time of randomization and ultimately at 24 months

Study Arms (2)

ProTouch Laser Enucleation of Prostate

ACTIVE COMPARATOR

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)

Transurethral Resection of Prostate

ACTIVE COMPARATOR

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)

Interventions

ProTouch Laser Enucleation of Prostate (LEP) 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.

ProTouch Laser Enucleation of Prostate

Transurethral Resection of Prostate (TURP) 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.

Transurethral Resection of Prostate

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston University: lead

Study Sites (1)

Boston University Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Transurethral Resection of Prostate

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Prostatectomy; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Shaun Wason, MD

  Boston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2017
• First Posted: February 23, 2017
• Study Start: October 23, 2017
• Primary Completion: January 15, 2021
• Study Completion: January 15, 2021
• Last Updated: February 3, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)