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HoLEP Vs BPEP for Large Prostatic Adenoma (enucleation)

Primary Purpose

Prostate Hyperplasia

Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Holmium laser enucleation of the prostate versus bipolar transurethral enucleation of the prostate in management of benign prostatic hyperplasia
Sponsored by
Ahmed Maher Gamil Ahmed Higazy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Hyperplasia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Men who are fit for surgery and need a surgical resection of the prostate larger than 80 ml including:

    1. Bothersome LUTS with an IPSS score over 19
    2. Refractory hematuria
    3. Upper urinary tract affection
    4. Recurrent UTI secondary to prostatic enlargement
    5. Maximum uroflow rate (Qmax) below 10 ml/sec.
    6. bladder diverticula
    7. Urinary retention whether recurrent acute attacks with failure of medical treatment or chronic retention.

Exclusion Criteria:

  • Patients with:

    1. Neurogenic bladder
    2. Previous prostate or urethral surgery
    3. Associated urethral stricture
    4. Prostate cancer diagnosed by TRUS biopsy
    5. Bladder stones,

Sites / Locations

  • Ain Shams University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Holmium laser enucleation of the prostate

bipolar transurethral enucleation of the prostate

Arm Description

Holmium laser enucleation of the prostate

bipolar transurethral enucleation of the prostate

Outcomes

Primary Outcome Measures

operative time
form the beginning of endoscopic procedure till catheter insertion

Secondary Outcome Measures

Enucleation efficacy of HoLEP
Mean Enucleation time (HoLEP) in minutes divided by Mean resected volume in grams
Enucleation efficacy of BEEP
Mean Enucleation time (BPEP) in minutes/ Mean resected volume in grams
Mean energy in (HoLEP) in joules
Mean energy in (HoLEP) in joules
irrigation fluid
Average Irrigation fluid used in each group in liters
catheter removal time
postoperative time till catheter removal
resected volume
resected volume in grams
hemoglobin drop
blood loss in dl/ml
conversion to other type of surgery
conversion to other types of surgeries like TURP, open surgery, procedure abortion
Operative safety:
capsular perforation, Yes/No
Operative safety:
morcellation injury, Yes/No
early post operative complication
stress incontinence, Yes/No
early post operative complication
urinary tract infection, Yes/No
early post operative complication
urine retention, Yes/No
Postoperative efficacy:
IPSS: international prostate symptom score
Postoperative efficacy:
QoL: quality of life questionnaire
Postoperative efficacy:
Qmax (m/sec.) : peak flow rate
Postoperative efficacy:
PVRU (ml): post voiding residual urine
Postoperative efficacy:
PSA (ng/ml): prostatic specific antigen
Postoperative efficacy:
postoperative prostate volume assessment in grams
cost effectiveness
Running cost in Egyptian pounds of the following: irrigation fluid, hospital stay, fiber, loop, management of complication in each group
hospital stay
duration of postoperative hospital stay in days
Cost analysis
average running cost evaluation in both procedure

Full Information

First Posted
February 12, 2020
Last Updated
June 12, 2020
Sponsor
Ahmed Maher Gamil Ahmed Higazy
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1. Study Identification

Unique Protocol Identification Number
NCT04275076
Brief Title
HoLEP Vs BPEP for Large Prostatic Adenoma
Acronym
enucleation
Official Title
Holmium Laser Enucleation of the Prostate Versus Bipolar Transurethral Enucleation of the Prostate in Management of Benign Prostatic Hyperplasia A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
February 1, 2020 (Actual)
Study Completion Date
February 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ahmed Maher Gamil Ahmed Higazy

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) 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
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Hyperplasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
patients, data collector, and the statistician all were blinded to the type of intervention that was used in each group.
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Holmium laser enucleation of the prostate
Arm Type
Experimental
Arm Description
Holmium laser enucleation of the prostate
Arm Title
bipolar transurethral enucleation of the prostate
Arm Type
Experimental
Arm Description
bipolar transurethral enucleation of the prostate
Intervention Type
Procedure
Intervention Name(s)
Holmium laser enucleation of the prostate versus bipolar transurethral enucleation of the prostate in management of benign prostatic hyperplasia
Intervention Description
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
Primary Outcome Measure Information:
Title
operative time
Description
form the beginning of endoscopic procedure till catheter insertion
Time Frame
50-120 minutes
Secondary Outcome Measure Information:
Title
Enucleation efficacy of HoLEP
Description
Mean Enucleation time (HoLEP) in minutes divided by Mean resected volume in grams
Time Frame
12 months
Title
Enucleation efficacy of BEEP
Description
Mean Enucleation time (BPEP) in minutes/ Mean resected volume in grams
Time Frame
12 months
Title
Mean energy in (HoLEP) in joules
Description
Mean energy in (HoLEP) in joules
Time Frame
intra-operative finding
Title
irrigation fluid
Description
Average Irrigation fluid used in each group in liters
Time Frame
intra-operative finding
Title
catheter removal time
Description
postoperative time till catheter removal
Time Frame
1-7 days
Title
resected volume
Description
resected volume in grams
Time Frame
intra-operative finding
Title
hemoglobin drop
Description
blood loss in dl/ml
Time Frame
intra-operative finding
Title
conversion to other type of surgery
Description
conversion to other types of surgeries like TURP, open surgery, procedure abortion
Time Frame
intra-operative finding
Title
Operative safety:
Description
capsular perforation, Yes/No
Time Frame
intra-operative finding
Title
Operative safety:
Description
morcellation injury, Yes/No
Time Frame
intra-operative finding
Title
early post operative complication
Description
stress incontinence, Yes/No
Time Frame
1 month
Title
early post operative complication
Description
urinary tract infection, Yes/No
Time Frame
1 month
Title
early post operative complication
Description
urine retention, Yes/No
Time Frame
1 month
Title
Postoperative efficacy:
Description
IPSS: international prostate symptom score
Time Frame
12 months
Title
Postoperative efficacy:
Description
QoL: quality of life questionnaire
Time Frame
12 months
Title
Postoperative efficacy:
Description
Qmax (m/sec.) : peak flow rate
Time Frame
12 months
Title
Postoperative efficacy:
Description
PVRU (ml): post voiding residual urine
Time Frame
12 months
Title
Postoperative efficacy:
Description
PSA (ng/ml): prostatic specific antigen
Time Frame
12 months
Title
Postoperative efficacy:
Description
postoperative prostate volume assessment in grams
Time Frame
12 months
Title
cost effectiveness
Description
Running cost in Egyptian pounds of the following: irrigation fluid, hospital stay, fiber, loop, management of complication in each group
Time Frame
12 months
Title
hospital stay
Description
duration of postoperative hospital stay in days
Time Frame
1-7 days
Title
Cost analysis
Description
average running cost evaluation in both procedure
Time Frame
1 year

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men who are fit for surgery and need a surgical resection of the prostate larger than 80 ml including: Bothersome LUTS with an IPSS score over 19 Refractory hematuria Upper urinary tract affection Recurrent UTI secondary to prostatic enlargement Maximum uroflow rate (Qmax) below 10 ml/sec. bladder diverticula Urinary retention whether recurrent acute attacks with failure of medical treatment or chronic retention. Exclusion Criteria: Patients with: Neurogenic bladder Previous prostate or urethral surgery Associated urethral stricture Prostate cancer diagnosed by TRUS biopsy Bladder stones,
Facility Information:
Facility Name
Ain Shams University Hospitals
City
Cairo
ZIP/Postal Code
11361
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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HoLEP Vs BPEP for Large Prostatic Adenoma

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