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

Benign Prostatic Hyperplasia Clinical Trial

Official title:

Laser Enucleation of Prostate (LEP) Versus Transurethral Resection of Prostate (TURP): a Prospective Study Comparing Outcomes

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03062111
• Other study ID #: H-36011
• Status: Terminated
• Phase: N/A
• Start date: October 23, 2017
• Est. completion date: January 15, 2021

Study information

• Verified date: January 2021
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: January 15, 2021
• Est. primary completion date: January 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Boston University Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Urinary Flow Rate	Velocity (in cc/sec) of the urine flow	From time of randomization and ultimately at 24 months
Secondary	Quality of Life score	Survey to determine how satisfied the patient is with urination	From time of randomization and ultimately at 24 months
Secondary	Blood loss	Amount of blood loss during surgery.	During surgery (full length of operative time)
Secondary	Catheter time	the amount of time a catheter must stay in place postoperatively	From time of surgery to up to 3 weeks after surgery.
Secondary	Post void residual	Amount of urine remaining in the bladder after voiding	From time of randomization and ultimately at 24 months
Secondary	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