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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| transurethral bipolar enucleation and resection of the prostate | Active Comparator | transurethral bipolar enucleation and resection of the prostate |
|
| open prostatectomy | Active Comparator | open surgical transvesical prostatectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transurethral bipolar enucleation and resection of the prostate | Procedure | transurethral bipolar enucleation and resection of the prostate |
|
| Measure | Description | Time Frame |
|---|---|---|
| operative time | To measure the difference between the two procedure regarding operative time measured in minutes. | Three months |
| recovery outcome | To measure the difference between the two procedure regarding mean hospital stays measured in days and catheterization period measured in days | Three months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Three months |
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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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tarek Salem, professor | Helwan university faculty of medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helwan university faculty of medicine | Helwan | 11731 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| 28012747 | Result | 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. | |
| Result | De Nunzio C, Lombardo R, Cicione AM, Tubaro A. Benign Prostatic Hyperplasia (BPH). Urologic Principles and Practice: Springer; 2020. p. 341-55. | ||
| 29775639 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 12, 2023 | |
| Reset | Feb 14, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 12, 2023 | Feb 14, 2024 |
| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D011468 | Prostatectomy |
| ID | Term |
|---|---|
| D013521 | Urologic Surgical Procedures, Male |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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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.
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|
| open surgical transvesical prostatectomy | Procedure | open surgical transvesical prostatectomy |
|
|
| weight of resected prostatic tissues | to measure the difference between the two procedures regarding weight of resected prostatic tissues Measured in gram | Three months |
| 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 | Three months |
| Result |
| 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. |
| 31839744 | Result | 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. |
| 22530928 | Result | 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. |
| 31156002 | Result | 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. |
| Result | 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. |
| 30131603 | Result | 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. |
| 31807429 | Result | 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. |
| D052801 |
| Male Urogenital Diseases |