Benign Prostatic Hyperplasia
Conditions
Keywords
Laser Enucleation of Prostate (LEP), Transurethral Resection of Prostate (TURP)
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.
Interventions
PROCEDUREProTouch 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.
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.
Sponsors
Boston University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Urinary Flow Rate | From time of randomization and ultimately at 24 months | Velocity (in cc/sec) of the urine flow |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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 |
Countries
United States
Outcome results
None listed