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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03062111
Recruitment Status : Suspended (Currently suspended due to Covid-19 policies.)
First Posted : February 23, 2017
Last Update Posted : April 21, 2020
Sponsor:
Information provided by (Responsible Party):
Boston University

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).


Condition or disease Intervention/treatment Phase
Benign Prostatic Hyperplasia Procedure: ProTouch Laser Enucleation of Prostate (LEP) Procedure: Transurethral Resection of Prostate (TURP) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Laser Enucleation of Prostate (LEP) Versus Transurethral Resection of Prostate (TURP): a Prospective Study Comparing Outcomes
Actual Study Start Date : October 23, 2017
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: ProTouch Laser Enucleation of Prostate
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)
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.

Active Comparator: Transurethral Resection of Prostate
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)
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 Measures :
  1. Change in Urinary Flow Rate [ Time Frame: From time of randomization and ultimately at 24 months ]
    Velocity (in cc/sec) of the urine flow


Secondary Outcome Measures :
  1. Quality of Life score [ Time Frame: From time of randomization and ultimately at 24 months ]
    Survey to determine how satisfied the patient is with urination

  2. Blood loss [ Time Frame: During surgery (full length of operative time) ]
    Amount of blood loss during surgery.

  3. Catheter time [ Time Frame: From time of surgery to up to 3 weeks after surgery. ]
    the amount of time a catheter must stay in place postoperatively

  4. Post void residual [ Time Frame: From time of randomization and ultimately at 24 months ]
    Amount of urine remaining in the bladder after voiding

  5. Sexual Health Inventory for Men (SHIM) [ Time Frame: From time of randomization and ultimately at 24 months ]
    Survey to assess baseline sexual function and whether this is affected by intervention type



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03062111


Locations
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United States, Massachusetts
Boston University Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston University
Investigators
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Principal Investigator: Shaun Wason, MD Boston University
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Responsible Party: Boston University
ClinicalTrials.gov Identifier: NCT03062111    
Other Study ID Numbers: H-36011
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: April 21, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Boston University:
Laser Enucleation of Prostate (LEP)
Transurethral Resection of Prostate (TURP)
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male