Laser Enucleation of Prostate (LEP) Versus Transurethral Resection of Prostate (TURP)
| Status: | Recruiting |
|---|---|
| Conditions: | Hematology, Benign Prostate Hyperplasia, Urology |
| Therapuetic Areas: | Hematology, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 50 - Any |
| Updated: | 3/28/2019 |
| Start Date: | October 23, 2017 |
| End Date: | March 2021 |
| Contact: | Shaun Wason, MD |
| Email: | shaun.wason@bmc.org |
| Phone: | 617-638-1004 |
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).
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).
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.
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.
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
We found this trial at
1
site
1 Boston Medical Center Place
Boston, Massachusetts 02118
Boston, Massachusetts 02118
617.638.8000
Phone: 617-638-1004
Boston University Medical Center Boston Medical Center is an extraordinary community of health care providers...
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