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HoLEP vs mTURP in Management of Benign Prostatic Hyperplasia

Primary Purpose

Prostatic Hyperplasia

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Holmium laser enucleation of prostate
monopolar transurethral resection of prostate
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Hyperplasia focused on measuring prostate, transurethral resection of prostate, HoLEP

Eligibility Criteria

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

Inclusion Criteria:

  • prostate volume less than 80 ml
  • high IPSS more than 19 affecting quality of life
  • recurrent urinary retention with failure of medical treatment
  • recurrent urinary tract infection
  • affection of upper urinary tract
  • refractory hematuria
  • bladder stones
  • bladder diverticula

Exclusion Criteria:

  • patients with neurogenic bladder
  • patients with previous prostate or urethral surgery
  • associated urethral stricture
  • prostate cancer diagnosed by TRUS biopsy
  • prostate volume more than 80 ml

Sites / Locations

  • Ainshams university hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Holmium laser enucleation of prostate

monopolar transurethral resection of prostate

Arm Description

patients that undergo Holmium laser enucleation of prostate (HoLEP) procedure

patients that undergo monopolar transurethral resection of prostate

Outcomes

Primary Outcome Measures

the international prostate symptom score (IPSS)
assessing the improvement of IPSS
maximum urine flow rate (Qmax)
assessing the improvement of Qmax

Secondary Outcome Measures

operative time
estimating the operative time in both groups in minutes
resected volume
measuring the resected volume of prostate after each operation
postoperative drop in hemaoglobin level
comparing postoperative hemoglobin level with preoperative level in both groups
postoperative drop in sodium level
comparing postoperative sodium level with preoperative level in both groups
postoperative catheterization time
assessing postoperative catheterization time in both groups
duration of hospital stay
assessing duration of hospital stay in both groups
postvoiding residual urine volume
assessing postvoiding residual urine volume in both groups
ultrasound assessed prostate volume
comparing ultrasound assessed prostate volume in both groups

Full Information

First Posted
September 18, 2020
Last Updated
September 18, 2020
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT04561505
Brief Title
HoLEP vs mTURP in Management of Benign Prostatic Hyperplasia
Official Title
Holmium Laser Enucleation of the Prostate Versus Monopolar Transurethral Resection of the Prostate in Management of Benign Prostatic Hyperplasia.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
February 1, 2020 (Actual)
Study Completion Date
February 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

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

5. Study Description

Brief Summary
To compare the clinical outcome regarding safety and efficacy between Holmium laser enucleation of the prostate and transurethral resection of the prostate in management of benign prostatic hyperplasia.
Detailed Description
Benign prostatic hyperplasia (BPH) affects 70% of men older than 70 years and is a significant cause of morbidity in this population. The symptoms of BPH include impaired physiological and functional well-being, which interferes with daily living. Lower urinary tract symptoms (LUTS) in elderly men are mainly related to an enlarged prostate, the actual link between an enlarged prostate and the onset of symptoms are multifactorial. LUTS include both irritative symptoms in the form of urgency, frequency, nocturnal enuresis and urge incontinence as well as obstructive symptoms comprise hesitancy, weak interrupted stream of urine, incomplete voiding which eventually affect the quality of life (QoL), the main goal of treatment is resolve these symptom. Multiple surgical options are available for management of benign prostatic hyperplasia (BPH) and its associated symptoms. Transurethral resection of the prostate (TURP) and open prostatectomy remain the gold standard surgical management. However, considerable morbidities are associated with both procedures and mainly related to the prostate size. These complications may be either patient or surgically related. The patient's related complications are cardiac arrhythmia, myocardial infarction, pulmonary embolism, exacerbation of previous respiratory disease, deep venous thrombosis and death. The surgical related complication includes bleeding, capsular perforation, urosepsis, incontinence, conversion to open surgery, bladder neck stenosis, redo surgery and transurethral resection syndrome. Clearly, a wide gap existed between simple medical therapy on one hand and TURP on the other hand. This wide gap is coupled with the need for a less morbid alternative to TURP that led to the emergence of various less invasive therapy among which Laser based minimally invasive procedure. Modern laser therapy for BPH has advantages over TURP including decreased blood loss and minimal serum electrolyte changes resulting in fewer cardiovascular complications, decreased catheter time, shorter hospital stay and the ability to treat patients on anticoagulation. Because of these potential advantages, there has been a shift in practice patterns with laser procedures accounting for 57% of surgical interventions for BPH, compared to traditional TURP which accounted for only 39% of interventions in 2005. Holmium laser enucleation of the prostate (HoLEP) is the most recent step in the evolution of holmium laser prostatectomy. HoLEP is a safe and effective surgical procedure, which has comparable results to transurethral resection of the prostate (TURP) and open prostatectomy, with low morbidity and short hospital stay. HoLEP is equally suitable for small, medium, and large prostate glands, with clinical outcomes that are independent of prostate size, and recently it has been proposed as a new gold standard for treatment of symptomatic benign prostatic hyperplasia (BPH). Currently, all BPH guidelines recommend HoLEP as a surgical treatment of BPH. For a procedure to be considered a gold standard, it must provide effective results, low morbidity, and durable outcomes. HoLEP, as many of the new alternative treatments for symptomatic BPH, has scanty data regarding its role in Egyptian population and if it can replace TURP to be the gold standard. To our best knowledge, no one estimated cost effectiveness between the two techniques in a developing country. Our study aimed to compare the efficacy, safety and cost effectiveness of HoLEP versus monopolar TURP in management of benign prostatic hyperplasia in a developing country.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Hyperplasia
Keywords
prostate, transurethral resection of prostate, HoLEP

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Holmium laser enucleation of prostate
Arm Type
Active Comparator
Arm Description
patients that undergo Holmium laser enucleation of prostate (HoLEP) procedure
Arm Title
monopolar transurethral resection of prostate
Arm Type
Active Comparator
Arm Description
patients that undergo monopolar transurethral resection of prostate
Intervention Type
Procedure
Intervention Name(s)
Holmium laser enucleation of prostate
Intervention Description
surgical management of BPH by Holmium laser enucleation using 0.9% saline fluid for irrigation
Intervention Type
Procedure
Intervention Name(s)
monopolar transurethral resection of prostate
Intervention Description
surgical management of BPH by monopolar TURP using distilled water for irrigation
Primary Outcome Measure Information:
Title
the international prostate symptom score (IPSS)
Description
assessing the improvement of IPSS
Time Frame
1 year
Title
maximum urine flow rate (Qmax)
Description
assessing the improvement of Qmax
Time Frame
1 year
Secondary Outcome Measure Information:
Title
operative time
Description
estimating the operative time in both groups in minutes
Time Frame
immediately postoperative
Title
resected volume
Description
measuring the resected volume of prostate after each operation
Time Frame
immediately postoperative
Title
postoperative drop in hemaoglobin level
Description
comparing postoperative hemoglobin level with preoperative level in both groups
Time Frame
1 day postoperative
Title
postoperative drop in sodium level
Description
comparing postoperative sodium level with preoperative level in both groups
Time Frame
1 day postoperative
Title
postoperative catheterization time
Description
assessing postoperative catheterization time in both groups
Time Frame
4 days postoperative
Title
duration of hospital stay
Description
assessing duration of hospital stay in both groups
Time Frame
3 days postoperative
Title
postvoiding residual urine volume
Description
assessing postvoiding residual urine volume in both groups
Time Frame
1 year
Title
ultrasound assessed prostate volume
Description
comparing ultrasound assessed prostate volume in both groups
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
cost analysis
Description
comparing cost analysis for each patient in both groups as regards running cost including laser fiber or monopolar loop, irrigation fluid and cost of hospital stay.
Time Frame
3 days postoperative
Title
complications
Description
assessing intraoperative, early postoperative and late postoperative complications in both groups
Time Frame
1 year

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
males only have prostate that will need surgical management of BPH
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: prostate volume less than 80 ml high IPSS more than 19 affecting quality of life recurrent urinary retention with failure of medical treatment recurrent urinary tract infection affection of upper urinary tract refractory hematuria bladder stones bladder diverticula Exclusion Criteria: patients with neurogenic bladder patients with previous prostate or urethral surgery associated urethral stricture prostate cancer diagnosed by TRUS biopsy prostate volume more than 80 ml
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salah Sayed, master
Organizational Affiliation
assistant lecturer of urology, Ainshams university hospital, Cairo, Egypt
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Amr Elshorbagy, PhD
Organizational Affiliation
professor of urology, Ainshams university hospital, Cairo, Egypt
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mahmoud A. Mahmoud, PhD
Organizational Affiliation
assistant professor of urology, Ainshams university hospital, Cairo, Egypt
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Diaaeldin Mostafa, PhD
Organizational Affiliation
assistant professor of urology, Ainshams university hospital, Cairo, Egypt
Official's Role
Study Director
Facility Information:
Facility Name
Ainshams university hospital
City
Cairo
ZIP/Postal Code
11361
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
8918007
Citation
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Results Reference
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Citation
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Results Reference
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PubMed Identifier
21883855
Citation
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Results Reference
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Links:
URL
https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.601.5664&rep=rep1&type=pdf
Description
european association of urology

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HoLEP vs mTURP in Management of Benign Prostatic Hyperplasia

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