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Prostate Bipolar Enucleation and Resection Versus Open Prostatectomy

NCT05416606 — Not applicable, Completed, 64 participants, Helwan University

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

RegistryNCT05416606
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment64 (Actual)
SponsorHelwan University (Other)
ConditionsBenign Prostatic Hyperplasia
Interventionstransurethral bipolar enucleation and resection of the prostate, open surgical transvesical prostatectomy (Procedure)
Datesstart 2020-10-01, primary completion 2022-06-01, completion 2022-06-01, first posted 2022-06-13, last updated 2022-06-13
Locations1 site in Egypt

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-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.

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+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).

+Arms and interventions

ArmTypeInterventionsDescription
transurethral bipolar enucleation and resection of the prostateActive comparatorProcedure: transurethral bipolar enucleation and resection of the prostatetransurethral bipolar enucleation and resection of the prostate
open prostatectomyActive comparatorProcedure: open surgical transvesical prostatectomyopen surgical transvesical prostatectomy
  • transurethral bipolar enucleation and resection of the prostate (Procedure), also known as TUVERP: transurethral bipolar enucleation and resection of the prostate
  • open surgical transvesical prostatectomy (Procedure), also known as Transvesical prostatectomy: open surgical transvesical prostatectomy

+Outcome measures

Primary outcomes

  • operative time [Three months]: To measure the difference between the two procedure regarding operative time measured in minutes.
  • recovery outcome [Three months]: To measure the difference between the two procedure regarding mean hospital stays measured in days and catheterization period measured in days

Secondary outcomes

  • peri-operative complication [Three months]: 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 [Three months]: 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. [Three months]: 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

+Eligibility

Sex: Male, ages: 50 Years to any

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.

+Locations (1)

FacilityCityCountryStatus
Helwan university faculty of medicineHelwanEgypt

+Publications

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

+Investigators

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