Prostate Bipolar Enucleation and Resection Versus Open Prostatectomy
Primary Purpose
Benign Prostatic Hyperplasia
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
transurethral bipolar enucleation and resection of the prostate
open surgical transvesical prostatectomy
Sponsored by
About this trial
This is an interventional treatment trial for Benign Prostatic Hyperplasia focused on measuring Transurethral enucleation, Transurethral enucleation and resection of the prostate, plasma enucleation, prostate enucleation, Open Prostatectomy, BPH, Benign prostatic hyperplasia
Eligibility Criteria
Inclusion Criteria:
- Male patients
- Age more than 50 years
- Prostate size of more than 80 ml
- IPSS ≥ 8, and maximum urinary flow rate (Qmax) ≤ 15 mL/s
Indications for surgery
- Refractory retention (failed ≥1 trial of voiding).
- Associated bladder Stones.
- Associated recurrent gross Hematuria.
- Associated with recurrent Infections.
- Associated renal insufficiency.
- Bother symptoms refractory to medical treatment.
Exclusion Criteria:
- Uncorrectable coagulopathy.
- Patient with active UTI.
- Prostate less than 80 ml.
- Severe associated comorbidities.
- Previous urethral, prostate, and bladder surgeries,
- Patients diagnosed with neurogenic bladder.
- Patients diagnosed with prostate cancer.
Sites / Locations
- Helwan university faculty of medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
transurethral bipolar enucleation and resection of the prostate
open prostatectomy
Arm Description
transurethral bipolar enucleation and resection of the prostate
open surgical transvesical prostatectomy
Outcomes
Primary Outcome Measures
operative time
To measure the difference between the two procedure regarding operative time measured in minutes.
recovery outcome
To measure the difference between the two procedure regarding mean hospital stays measured in days and catheterization period measured in days
Secondary Outcome Measures
peri-operative complication
to measure the difference between the two procedures regarding incidence of early complications including re-catheterization, acute urinary retention, early irritative symptoms and urinary tract infections and incidence of late complications Including urinary incontinence, Urethral strictures,and bladder neck contracture.
weight of resected prostatic tissues
to measure the difference between the two procedures regarding weight of resected prostatic tissues Measured in gram
post-operative International Prostate Symptom Score (IPSS) score.
to measure the difference between the two procedures regarding IPSS score. Score 0 to 7 points considered mild symptoms, 8 to 19 points considered moderate symptoms, 20 to 35 points considered severe symptoms
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05416606
Brief Title
Prostate Bipolar Enucleation and Resection Versus Open Prostatectomy
Official Title
Transurethral Bipolar Enucleation and Resection of the Prostate Versus Open Prostatectomy for the Treatment of Benign Prostatic Hyperplasia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
June 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helwan 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
Benign prostatic hyperplasia (BPH) is a frequent disease in aging men accompanied by bladder outlet obstruction (BOO). Open prostatectomy (OP) is still considered the first-line treatment for more than 80 ml prostate size. In this study, a mixed technique called transurethral bipolar enucleation and resection of the prostate (TBERP) was compared to the standard open prostatectomy.
Detailed Description
Benign prostatic hyperplasia (BPH) is a frequent disease in aging men accompanied by bladder outlet obstruction (BOO). Open prostatectomy (OP) is still considered the first-line treatment for more than 80 ml prostate size. In this study, a mixed technique called transurethral bipolar enucleation and resection of the prostate (TBERP) was compared to the standard open prostatectomy.
This is a Comparative, Prospective Study conducted on men over 50 years.The patients were randomly distributed into two groups treated by TBERP and OP. Patients were evaluated preoperatively and at 1-week post catheter removal and 1-3-months postoperatively in terms of blood loss, operation time, the weight of resected prostatic tissues, post-operative catheterisation period, hospital stay, IPSS, PVR, prostate volume, early complications (recatheterization, urine retention, UTI and irritative symptoms) and late complications (urinary incontinence, urethral stricture and bladder neck contracture).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia
Keywords
Transurethral enucleation, Transurethral enucleation and resection of the prostate, plasma enucleation, prostate enucleation, Open Prostatectomy, BPH, Benign prostatic hyperplasia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
In this study, a hybrid technique, that combines two types of techniques using the same cutting current and technological setup, will be proposed enucleation of the prostate gland with the plasma vaporization electrode and resection with a TURis cutting loop. This technique is defined as transurethral vapor enucleation and resection of the prostate (TVERP) comparing it with open prostatectomy.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
transurethral bipolar enucleation and resection of the prostate
Arm Type
Active Comparator
Arm Description
transurethral bipolar enucleation and resection of the prostate
Arm Title
open prostatectomy
Arm Type
Active Comparator
Arm Description
open surgical transvesical prostatectomy
Intervention Type
Procedure
Intervention Name(s)
transurethral bipolar enucleation and resection of the prostate
Other Intervention Name(s)
TUVERP
Intervention Description
transurethral bipolar enucleation and resection of the prostate
Intervention Type
Procedure
Intervention Name(s)
open surgical transvesical prostatectomy
Other Intervention Name(s)
Transvesical prostatectomy
Intervention Description
open surgical transvesical prostatectomy
Primary Outcome Measure Information:
Title
operative time
Description
To measure the difference between the two procedure regarding operative time measured in minutes.
Time Frame
Three months
Title
recovery outcome
Description
To measure the difference between the two procedure regarding mean hospital stays measured in days and catheterization period measured in days
Time Frame
Three months
Secondary Outcome Measure Information:
Title
peri-operative complication
Description
to measure the difference between the two procedures regarding incidence of early complications including re-catheterization, acute urinary retention, early irritative symptoms and urinary tract infections and incidence of late complications Including urinary incontinence, Urethral strictures,and bladder neck contracture.
Time Frame
Three months
Title
weight of resected prostatic tissues
Description
to measure the difference between the two procedures regarding weight of resected prostatic tissues Measured in gram
Time Frame
Three months
Title
post-operative International Prostate Symptom Score (IPSS) score.
Description
to measure the difference between the two procedures regarding IPSS score. Score 0 to 7 points considered mild symptoms, 8 to 19 points considered moderate symptoms, 20 to 35 points considered severe symptoms
Time Frame
Three months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male patients
Age more than 50 years
Prostate size of more than 80 ml
IPSS ≥ 8, and maximum urinary flow rate (Qmax) ≤ 15 mL/s
Indications for surgery
Refractory retention (failed ≥1 trial of voiding).
Associated bladder Stones.
Associated recurrent gross Hematuria.
Associated with recurrent Infections.
Associated renal insufficiency.
Bother symptoms refractory to medical treatment.
Exclusion Criteria:
Uncorrectable coagulopathy.
Patient with active UTI.
Prostate less than 80 ml.
Severe associated comorbidities.
Previous urethral, prostate, and bladder surgeries,
Patients diagnosed with neurogenic bladder.
Patients diagnosed with prostate cancer.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tarek Salem, professor
Organizational Affiliation
Helwan university faculty of medicine
Official's Role
Study Director
Facility Information:
Facility Name
Helwan university faculty of medicine
City
Helwan
ZIP/Postal Code
11731
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
Citation
Mahon JT, McVary KT. New Alternative Treatments for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia. Minimally Invasive Urology: Springer; 2020. p. 283-305.
Results Reference
background
PubMed Identifier
28012747
Citation
Barry MJ, Fowler FJ Jr, O'leary MP, Bruskewitz RC, Holtgrewe HL, Mebust WK, Cockett AT; Measurement Committee of the American Urological Association. The American Urological Association Symptom Index for Benign Prostatic Hyperplasia. J Urol. 2017 Feb;197(2S):S189-S197. doi: 10.1016/j.juro.2016.10.071. Epub 2016 Dec 22.
Results Reference
result
Citation
De Nunzio C, Lombardo R, Cicione AM, Tubaro A. Benign Prostatic Hyperplasia (BPH). Urologic Principles and Practice: Springer; 2020. p. 341-55.
Results Reference
result
PubMed Identifier
29775639
Citation
Foster HE, Barry MJ, Dahm P, Gandhi MC, Kaplan SA, Kohler TS, Lerner LB, Lightner DJ, Parsons JK, Roehrborn CG, Welliver C, Wilt TJ, McVary KT. Surgical Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: AUA Guideline. J Urol. 2018 Sep;200(3):612-619. doi: 10.1016/j.juro.2018.05.048. Epub 2018 Jun 11.
Results Reference
result
PubMed Identifier
31839744
Citation
Zheng X, Han X, Cao D, Wang Y, Xu H, Yang L, Wei Q, Ai J. Comparison of Short-Term Outcomes between Button-Type Bipolar Plasma Vaporization and Transurethral Resection for the Prostate: A Systematic Review and Meta-Analysis. Int J Med Sci. 2019 Oct 21;16(12):1564-1572. doi: 10.7150/ijms.38618. eCollection 2019.
Results Reference
result
PubMed Identifier
22530928
Citation
Xie L, Mao Q, Chen H, Qin J, Zheng X, Lin Y, Wang X, Liu B. Transurethral vapor enucleation and resection of the prostate with plasma vaporization button electrode for the treatment of benign prostatic hyperplasia: a feasibility study. J Endourol. 2012 Oct;26(10):1264-6. doi: 10.1089/end.2012.0125. Epub 2012 Sep 12.
Results Reference
result
PubMed Identifier
31156002
Citation
Sagen E, Namnuan RO, Hedelin H, Nelzen O, Peeker R. The morbidity associated with a TURP procedure in routine clinical practice, as graded by the modified Clavien-Dindo system. Scand J Urol. 2019 Aug;53(4):240-245. doi: 10.1080/21681805.2019.1623312. Epub 2019 Jun 3.
Results Reference
result
Citation
Morton S, McGuiness L, Harding C, Thorpe A. A review of surgery and new technology procedures for the management of benign prostatic obstruction. Journal of Clinical Urology. 2019;12(6):474-86.
Results Reference
result
PubMed Identifier
30131603
Citation
Giulianelli R, Gentile BC, Mirabile G, Tema G, Albanesi L, Tariciotti P, Rizzo G, Falavolti C, Aloisi P, Vincenti G, Lombardo R. Bipolar plasma enucleation of the prostate vs. open prostatectomy in large benign prostatic hyperplasia: a single centre 3-year comparison. Prostate Cancer Prostatic Dis. 2019 Mar;22(1):110-116. doi: 10.1038/s41391-018-0080-7. Epub 2018 Aug 21.
Results Reference
result
PubMed Identifier
31807429
Citation
Lokeshwar SD, Harper BT, Webb E, Jordan A, Dykes TA, Neal DE Jr, Terris MK, Klaassen Z. Epidemiology and treatment modalities for the management of benign prostatic hyperplasia. Transl Androl Urol. 2019 Oct;8(5):529-539. doi: 10.21037/tau.2019.10.01.
Results Reference
result
Learn more about this trial
Prostate Bipolar Enucleation and Resection Versus Open Prostatectomy
We'll reach out to this number within 24 hrs