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Benign Prostatic HyperplasiaNCT05416606

Prostate Bipolar Enucleation and Resection Versus Open Prostatectomy

A study testing transurethral bipolar enucleation and resection of the prostate and open surgical transvesical prostatectomy in people with Benign Prostatic Hyperplasia, run by Helwan University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 50 years and older, men only
Conditions the study is for
Benign Prostatic Hyperplasia
What is being tested?
transurethral bipolar enucleation and resection of the prostate and open surgical transvesical prostatectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
1 siteEgypt
Study dates
1 Oct 2020to 1 Jun 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
Show all 11Show fewer
  • Associated bladder Stones.
  • Associated recurrent gross Hematuria.
  • Associated with recurrent Infections.
  • Associated renal insufficiency.
  • Bother symptoms refractory to medical treatment.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Helwan university faculty of medicine

    Helwan, 11731

Other trials in Egypt

About this study

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

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.

Read the 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).

Being tested
transurethral bipolar enucleation and resection of the prostate, open surgical transvesical prostatectomy
Keywords
Transurethral enucleation, Transurethral enucleation and resection of the prostate, plasma enucleation, prostate enucleation, Open Prostatectomy, BPH, Benign prostatic hyperplasia
Medical subject headings
Prostatic Hyperplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • transurethral bipolar enucleation and resection of the prostateProcedure or surgery

    Also called TUVERP

    transurethral bipolar enucleation and resection of the prostate

  • open surgical transvesical prostatectomyProcedure or surgery

    Also called Transvesical prostatectomy

    open surgical transvesical prostatectomy

Study groups in NCT05416606
Study groupRoleWhat they receive
transurethral bipolar enucleation and resection of the prostateActive comparatortransurethral bipolar enucleation and resection of the prostate
Receives: Procedure: transurethral bipolar enucleation and resection of the prostate
open prostatectomyActive comparatoropen surgical transvesical prostatectomy
Receives: Procedure: open surgical transvesical prostatectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. operative time

    To measure the difference between the two procedure regarding operative time measured in minutes.

    Measured: Three months

  2. recovery outcome

    To measure the difference between the two procedure regarding mean hospital stays measured in days and catheterization period measured in days

    Measured: Three months

Secondary outcomes (3)

  1. 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.

    Measured: Three months

  2. weight of resected prostatic tissues

    to measure the difference between the two procedures regarding weight of resected prostatic tissues Measured in gram

    Measured: Three months

  3. 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

    Measured: Three months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2022
  2. Study start1 Oct 2020
  3. Primary completion1 Jun 2022
  4. Study completion1 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05416606
Sponsor's protocol ID
51-2020
Status last verified
Jun 2022
First submitted
5 Jun 2022
Last updated
13 Jun 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

  • 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.

    PubMed 28012747

  • 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. J Urol. 2018 Sep;200(3):612-619. doi: 10.1016/j.juro.2018.05.048. Epub 2018 Jun 11.

    PubMed 29775639

  • 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.

    PubMed 31839744

  • 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.

    PubMed 22530928

  • 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.

    PubMed 31156002

  • 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.

  • 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.

    PubMed 30131603

  • 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.

    PubMed 31807429

Questions about this trial

What is this clinical trial studying?

A study testing transurethral bipolar enucleation and resection of the prostate and open surgical transvesical prostatectomy in people with Benign Prostatic Hyperplasia, run by Helwan University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

operative time (time frame: Three months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05416606, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2022.

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Clinical Trial NCT05416606 | AzTrials