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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Benign Prostatic Hyperplasia

Intervention / Treatment
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* Procedure: ProTouch Laser Enucleation of Prostate (LEP)
* Procedure: Transurethral Resection of Prostate (TURP)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ProTouch Laser Enucleation of Prostate<br>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)<br>* 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.<br>|
| Active Comparator: Transurethral Resection of Prostate<br>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)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Urinary Flow Rate | Velocity (in cc/sec) of the urine flow | From time of randomization and ultimately at 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life score | Survey to determine how satisfied the patient is with urination | From time of randomization and ultimately at 24 months | 
| Blood loss | Amount of blood loss during surgery. | During surgery (full length of operative time) | 
| Catheter time | the amount of time a catheter must stay in place postoperatively | From time of surgery to up to 3 weeks after surgery. | 
| Post void residual | Amount of urine remaining in the bladder after voiding | From time of randomization and ultimately at 24 months | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laser Enucleation of Prostate (LEP), Transurethral Resection of Prostate (TURP)