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

Not Applicable

Terminated

• Conditions: Benign Prostatic Hyperplasia
• Interventions: Procedure: ProTouch Laser Enucleation of Prostate (LEP); Procedure: Transurethral Resection of Prostate (TURP)

• Registration Number: NCT03062111
• Lead Sponsor: Boston University

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.

Study Timeline

• Study First Submitted: 2017-01-30
• Study First Submitted QC: 2017-02-20
• Study First Posted: 2017-02-23
• Study Start: 2017-10-23
• Status Verified: 2021-01
• Primary Completion: 2021-01-15
• Study Completion: 2021-01-15
• Last Update Submitted: 2021-01-31
• Last Update Posted: 2021-02-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 3

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ProTouch Laser Enucleation of Prostate	ProTouch Laser Enucleation of Prostate (LEP)	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
Transurethral Resection of Prostate	Transurethral Resection of Prostate (TURP)	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Boston University Medical Center; 🇺🇸 Boston, Massachusetts, United States