Laser Enucleation of Prostate (LEP) Versus Transurethral Resection of Prostate (TURP)
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|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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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.
- Change in Urinary Flow Rate [ Time Frame: From time of randomization and ultimately at 24 months ]Velocity (in cc/sec) of the urine flow
- 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
- Blood loss [ Time Frame: During surgery (full length of operative time) ]Amount of blood loss during surgery.
- 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
- Post void residual [ Time Frame: From time of randomization and ultimately at 24 months ]Amount of urine remaining in the bladder after voiding
- 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
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
|United States, Massachusetts|
|Boston University Medical Center|
|Boston, Massachusetts, United States, 02118|
|Principal Investigator:||Shaun Wason, MD||Boston University|