Viewing Study NCT05416606


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Ignite Modification Date: 2026-03-02 @ 4:36 PM
Study NCT ID: NCT05416606
Status: COMPLETED
Last Update Posted: 2022-06-13
First Post: 2022-06-05
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Prostate Bipolar Enucleation and Resection Versus Open Prostatectomy
Sponsor: Helwan University
Organization:

Study Overview

Official Title: Transurethral Bipolar Enucleation and Resection of the Prostate Versus Open Prostatectomy for the Treatment of Benign Prostatic Hyperplasia
Status: COMPLETED
Status Verified Date: 2022-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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.
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 Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: