Prostate Bipolar Enucleation and Resection Versus Open Prostatectomy

• Sponsor: Helwan University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05416606
• Collaborator: (none)
• Enrollment: 64
• Location: 1
• Arms: 2
• Actual Duration (Months): 20
• Patients Per Site Per Month: 3.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Benign Prostatic Hyperplasia	Procedure: transurethral bipolar enucleation and resection of the prostate; Procedure: open surgical transvesical prostatectomy	N/A

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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 64 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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.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)
• Primary Purpose: Treatment
• Official Title: Transurethral Bipolar Enucleation and Resection of the Prostate Versus Open Prostatectomy for the Treatment of Benign Prostatic Hyperplasia
• Actual Study Start Date: Oct 1, 2020
• Actual Primary Completion Date: Jun 1, 2022
• Actual Study Completion Date: Jun 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: transurethral bipolar enucleation and resection of the prostate transurethral bipolar enucleation and resection of the prostate	Procedure: transurethral bipolar enucleation and resection of the prostate; transurethral bipolar enucleation and resection of the prostate; Other Names: TUVERP
Active Comparator: open prostatectomy open surgical transvesical prostatectomy	Procedure: open surgical transvesical prostatectomy; open surgical transvesical prostatectomy; Other Names: Transvesical prostatectomy

Outcome Measures

Primary Outcome Measures

1. operative time [Three months]

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

2. 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 Outcome Measures

1. 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.

2. weight of resected prostatic tissues [Three months]

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

3. 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 Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Helwan university faculty of medicine	Helwan		Egypt	11731

Sponsors and Collaborators

• Helwan University

Investigators

• Study Director: Tarek Salem, professor, Helwan university faculty of medicine

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: Mohamed Fawzy Hassan Mahdy Elsyaad, Principal Investigator, Helwan University
• ClinicalTrials.gov Identifier: NCT05416606
• Other Study ID Numbers: 51-2020
• First Posted: Jun 13, 2022
• Last Update Posted: Jun 13, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Mohamed Fawzy Hassan Mahdy Elsyaad, Principal Investigator, Helwan University: Transurethral enucleation; Transurethral enucleation and resection of the prostate; plasma enucleation; prostate enucleation; Open Prostatectomy; BPH; Benign prostatic hyperplasia
• Additional relevant MeSH terms: Prostatic Hyperplasia; Hyperplasia

Study Results

No Results Posted as of Jun 13, 2022