Prostate Bipolar Enucleation and Resection Versus Open Prostatectomy

Benign Prostatic Hyperplasia Clinical Trial

Official title:

Transurethral Bipolar Enucleation and Resection of the Prostate Versus Open Prostatectomy for the Treatment of Benign Prostatic Hyperplasia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05416606
• Other study ID #: 51-2020
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: June 1, 2022

Study information

• Verified date: June 2022
• Source: Helwan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Procedure:
• transurethral bipolar enucleation and resection of the prostate
transurethral bipolar enucleation and resection of the prostate
• open surgical transvesical prostatectomy
open surgical transvesical prostatectomy

Locations

Country	Name	City	State
Egypt	Helwan university faculty of medicine	Helwan

Sponsors (1)

Lead Sponsor	Collaborator
Helwan University

Country where clinical trial is conducted

Egypt, 

References & Publications (10)

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( — View Citation

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

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. — View Citation

Giulianelli R, Gentile BC, Mirabile G, Tema G, Albanesi L, Tariciotti P, et al. Bipolar plasma enucleation of the prostate vs. open prostatectomy in large benign prostatic hyperplasia: a single centre 3-year comparison. Prostate cancer and prostatic disea

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. Revi — View 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.

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.

Sagen E, Namnuan RO, Hedelin H, Nelzén 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 — View 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 Oc — View 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( — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	operative time	To measure the difference between the two procedure regarding operative time measured in minutes.	Three months
Primary	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	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
Secondary	weight of resected prostatic tissues	to measure the difference between the two procedures regarding weight of resected prostatic tissues Measured in gram	Three months
Secondary	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