A Phase 3 interventional study of Holmium laser enucleation of the prostate versus bipolar transurethral enucleation of the prostate in management of benign prostatic hyperplasia in Prostate Hyperplasia, sponsored by Ahmed Maher Gamil Ahmed Higazy. Completed at 1 site in Egypt. Open to male participants. Per ClinicalTrials.gov, last updated 2020-06-16.
Sponsored by Ahmed Maher Gamil Ahmed Higazy · Phase 3, Interventional, and Treatment
Benign prostatic hyperplasia (BPH) is one of the most common urinary disorders in elderly males. The symptoms of BPH include impaired physiological and functional well-being, which interferes with daily living.
At present, transurethral resection of the prostate (TURP) is the standard surgical treatment. However, the high rate of complications associated with TURP is a major drawback of this procedure.
Holmium laser enucleation of the prostate (HoLEP) was proven to be an effective surgical treatment for BPH with no prostate size limitation with adequate hemostasis, bipolar enucleation of the prostate (BPEP) has been introduced as an alternative energy source with a promising outcome with equal safety and efficacy
Enlarged prostate represents the most common cause of lower urinary tract symptoms (LUTS) in elderly men including irritative, obstructive urinary symptoms or even urinary retention that significantly affects the quality life (QoL).
Transurethral resection of the prostate (TURP) represents the standard surgical technique for the management of benign prostatic hyperplasia (BPH) with a prostate size less than 80 ml. However, considerable morbidities are associated with larger sizes.
Endoscopic enucleation of the prostate (EEP) has been recognized as a treatment option for large prostatic adenomas, since first described by Hiraoka et.al, in 1986, it started to gain popularity despite the long learning curve. Many studies have evaluated its efficacy against the gold standard open prostatectomy in large prostate size more than 80ml and showed its safety and efficacy.
EEP represents an anatomical surgical technique resembling a surgeon's finger in open prostatectomy where any energy source that provides adequate haemostasis could be used. Many studies concluded that EEP relies on the surgeon's skills rather than the energy source itself. Holmium laser enucleation of the prostate (HoLEP) was first described by Gilling in 1998 and was proven to be effective with no prostate size limitation with adequate haemostasis, recently it has been approved as a standard treatment for large prostatic adenoma, bipolar enucleation of the prostate (BPEP) has been introduced as an alternative energy source with a promising outcome with equal safety and efficacy.
Few studies evaluated both techniques, one study was done by Shoma et al. showing no statistical difference regarding safety and efficacy between both techniques, another study conducted by Enikeev et al. reported earlier recovery and catheter removal with HoLEP compared to BPEP. However, cost-effectiveness was never been evaluated before between both techniques especially in developing countries.
With such scarce information, the investigators aimed through this study to compare these two energy sources in the enucleation procedure of the prostate in terms of safety, efficacy, and cost-effectiveness in the management of BPH in large prostatic adenoma more than 80 ml.
783 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.
This study's enrollment of 100 is close to the median of 97 across 593 interventional studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →This is the only study on the registry with Ahmed Maher Gamil Ahmed Higazy as lead sponsor.
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Men who are fit for surgery and need a surgical resection of the prostate larger than 80 ml including:
Exclusion Criteria:
Patients with:
Holmium laser enucleation of the prostate
Procedure: Holmium laser enucleation of the prostate versus bipolar transurethral enucleation of the prostate in management of benign prostatic hyperplasia
bipolar transurethral enucleation of the prostate
Procedure: Holmium laser enucleation of the prostate versus bipolar transurethral enucleation of the prostate in management of benign prostatic hyperplasia
comparison between 2 energy sources of enucleation in management of benign prostatic hyperplasia, holmium laser versus bipolar energy source in trans-urethral enucleation of the prostate
operative time
form the beginning of endoscopic procedure till catheter insertion
Time frame: 50-120 minutes
Enucleation efficacy of HoLEP
Mean Enucleation time (HoLEP) in minutes divided by Mean resected volume in grams
Time frame: 12 months
Enucleation efficacy of BEEP
Mean Enucleation time (BPEP) in minutes/ Mean resected volume in grams
Time frame: 12 months
Mean energy in (HoLEP) in joules
Mean energy in (HoLEP) in joules
Time frame: intra-operative finding
irrigation fluid
Average Irrigation fluid used in each group in liters
Time frame: intra-operative finding
catheter removal time
postoperative time till catheter removal
Time frame: 1-7 days
resected volume
resected volume in grams
Time frame: intra-operative finding
hemoglobin drop
blood loss in dl/ml
Time frame: intra-operative finding
conversion to other type of surgery
conversion to other types of surgeries like TURP, open surgery, procedure abortion
Time frame: intra-operative finding
Operative safety:
capsular perforation, Yes/No
Time frame: intra-operative finding
Operative safety:
morcellation injury, Yes/No
Time frame: intra-operative finding
early post operative complication
stress incontinence, Yes/No
Time frame: 1 month
early post operative complication
urinary tract infection, Yes/No
Time frame: 1 month
early post operative complication
urine retention, Yes/No
Time frame: 1 month
Postoperative efficacy:
IPSS: international prostate symptom score
Time frame: 12 months
Postoperative efficacy:
QoL: quality of life questionnaire
Time frame: 12 months
Postoperative efficacy:
Qmax (m/sec.) : peak flow rate
Time frame: 12 months
Postoperative efficacy:
PVRU (ml): post voiding residual urine
Time frame: 12 months
Postoperative efficacy:
PSA (ng/ml): prostatic specific antigen
Time frame: 12 months
Postoperative efficacy:
postoperative prostate volume assessment in grams
Time frame: 12 months
cost effectiveness
Running cost in Egyptian pounds of the following: irrigation fluid, hospital stay, fiber, loop, management of complication in each group
Time frame: 12 months
hospital stay
duration of postoperative hospital stay in days
Time frame: 1-7 days
Cost analysis
average running cost evaluation in both procedure
Time frame: 1 year
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