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

Primary Purpose

Benign Prostatic Hyperplasia

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ProTouch Laser Enucleation of Prostate (LEP)
Transurethral Resection of Prostate (TURP)
Sponsored by
Boston University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Benign Prostatic Hyperplasia focused on measuring Laser Enucleation of Prostate (LEP), Transurethral Resection of Prostate (TURP)

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Boston University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

ProTouch Laser Enucleation of Prostate

Transurethral Resection of Prostate

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Change in Urinary Flow Rate
Velocity (in cc/sec) of the urine flow

Secondary Outcome Measures

Quality of Life score
Survey to determine how satisfied the patient is with urination
Blood loss
Amount of blood loss during surgery.
Catheter time
the amount of time a catheter must stay in place postoperatively
Post void residual
Amount of urine remaining in the bladder after voiding
Sexual Health Inventory for Men (SHIM)
Survey to assess baseline sexual function and whether this is affected by intervention type

Full Information

First Posted
January 30, 2017
Last Updated
January 31, 2021
Sponsor
Boston University
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1. Study Identification

Unique Protocol Identification Number
NCT03062111
Brief Title
Laser Enucleation of Prostate (LEP) Versus Transurethral Resection of Prostate (TURP)
Official Title
Laser Enucleation of Prostate (LEP) Versus Transurethral Resection of Prostate (TURP): a Prospective Study Comparing Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Terminated
Why Stopped
Study was stopped due to low enrollment.
Study Start Date
October 23, 2017 (Actual)
Primary Completion Date
January 15, 2021 (Actual)
Study Completion Date
January 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia
Keywords
Laser Enucleation of Prostate (LEP), Transurethral Resection of Prostate (TURP)

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ProTouch Laser Enucleation of Prostate
Arm Type
Active Comparator
Arm Description
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
Arm Title
Transurethral Resection of Prostate
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
ProTouch Laser Enucleation of Prostate (LEP)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Transurethral Resection of Prostate (TURP)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Urinary Flow Rate
Description
Velocity (in cc/sec) of the urine flow
Time Frame
From time of randomization and ultimately at 24 months
Secondary Outcome Measure Information:
Title
Quality of Life score
Description
Survey to determine how satisfied the patient is with urination
Time Frame
From time of randomization and ultimately at 24 months
Title
Blood loss
Description
Amount of blood loss during surgery.
Time Frame
During surgery (full length of operative time)
Title
Catheter time
Description
the amount of time a catheter must stay in place postoperatively
Time Frame
From time of surgery to up to 3 weeks after surgery.
Title
Post void residual
Description
Amount of urine remaining in the bladder after voiding
Time Frame
From time of randomization and ultimately at 24 months
Title
Sexual Health Inventory for Men (SHIM)
Description
Survey to assess baseline sexual function and whether this is affected by intervention type
Time Frame
From time of randomization and ultimately at 24 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaun Wason, MD
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston University Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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