Prostate Bipolar Enucleation and Resection Versus Open Prostatectomy

NCT05416606 | Completed DMC

• 1 other identifier: 51-2020
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Prostatic Hyperplasia

Keywords

Transurethral enucleation; Transurethral enucleation and resection of the prostate; plasma enucleation; prostate enucleation; Open Prostatectomy; BPH; Benign prostatic hyperplasia

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• peri-operative complication

  Three months

• weight of resected prostatic tissues

  Three months

• post-operative International Prostate Symptom Score (IPSS) score.

  Three months

Study Arms (2)

transurethral bipolar enucleation and resection of the prostate

ACTIVE COMPARATOR

transurethral bipolar enucleation and resection of the prostate

Procedure: transurethral bipolar enucleation and resection of the prostate

open prostatectomy

ACTIVE COMPARATOR

open surgical transvesical prostatectomy

Procedure: open surgical transvesical prostatectomy

Interventions

transurethral bipolar enucleation and resection of the prostate PROCEDURE

transurethral bipolar enucleation and resection of the prostate

Also known as: TUVERP

transurethral bipolar enucleation and resection of the prostate

open surgical transvesical prostatectomy PROCEDURE

open surgical transvesical prostatectomy

Also known as: Transvesical prostatectomy

open prostatectomy

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Helwan University: lead

Study Sites (1)

Helwan university faculty of medicine

Helwan, 11731, Egypt

Location

Related Publications (10)

• 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.

  BACKGROUND

• 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.

  PMID: 28012747 RESULT

• De Nunzio C, Lombardo R, Cicione AM, Tubaro A. Benign Prostatic Hyperplasia (BPH). Urologic Principles and Practice: Springer; 2020. p. 341-55.

  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.

  PMID: 29775639 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.

  PMID: 31839744 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.

  PMID: 22530928 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.

  PMID: 31156002 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.

  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.

  PMID: 30131603 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.

  PMID: 31807429 RESULT

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Prostatectomy

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Tarek Salem, professor

  Helwan university faculty of medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 5, 2022
• First Posted: June 13, 2022
• Study Start: October 1, 2020
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: June 13, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)