Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2025-12-24 @ 4:18 PM
Study NCT ID:
NCT06758466
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-03
First Post:
2024-12-27
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bipolar TURP Versus Bipolar Enucleation for BPH Management
Sponsor:
Kasr El Aini Hospital
Organization:
Study Overview
Official Title:
A Prospective Randomized Controlled Trial Comparing Bipolar TURP and Bipolar Enucleation of the Prostate for Benign Prostatic Hyperplasia (BPH) With Prostate Volumes Between 30-80 Grams
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-01
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:
To compare the surgical outcomes at 12 months post-surgery between Bipolar TURP and BipoLEP in men with BPH and prostate volumes between 30-80 grams.
Detailed Description:
Create a research protocol in a prospective study to compare bipolar transurethral resection of prostate vs bipolar enucleation of prostate between 30 and 80 gm in management of BPH
Okay, here's a detailed research protocol for a prospective study comparing Bipolar Transurethral Resection of the Prostate (TURP) and Bipolar Enucleation of the Prostate (BipoLEP) for BPH, specifically focusing on prostates between 30-80 grams:
Study Title: A Prospective Randomized Controlled Trial Comparing Bipolar TURP and Bipolar Enucleation of the Prostate for Benign Prostatic Hyperplasia (BPH) with Prostate Volumes between 30-80 grams
1\. Introduction
Background: Briefly introduce Benign Prostatic Hyperplasia (BPH), its prevalence, and the associated lower urinary tract symptoms (LUTS). Highlight the common surgical interventions: TURP and, more recently, enucleation techniques.
Problem Statement: State that while both bipolar TURP and BipoLEP are established treatments, there's a need for a direct comparison, especially for moderate-sized prostates (30-80g). There's an ongoing debate regarding which approach offers superior outcomes and a better balance of efficacy and safety.
Rationale: Explain why this study is necessary. This can be because there is limited direct
Primary Objective: To compare the International Prostate Symptom Score (IPSS) at 12 months post-surgery between Bipolar TURP and BipoLEP in men with BPH and prostate volumes between 30-80 grams.
Secondary Objectives:
To compare perioperative outcomes including:
Operative time (minutes)
Catheterization time (days)
Length of hospital stay (days)
Blood loss (change in hemoglobin)
Requirement of blood transfusion
Incidence of perioperative complications (e.g., TUR syndrome, bleeding, infection, clot retention)
To compare postoperative functional outcomes including:
Peak urinary flow rate (Qmax) at 3, 6, and 12 months
Post-void residual (PVR) volume at 3, 6, and 12 months
Quality of life (QoL) using a validated questionnaire at 3, 6, and 12 months
To compare the incidence of postoperative complications including:
Urinary tract infection (UTI)
Urinary incontinence (UI)
Urethral stricture
Bladder neck contracture
Need for re-operation within 12 months.
To compare overall patient satisfaction using a visual analog scale (VAS) at 3, 6, and 12 months
Okay, here's a detailed research protocol for a prospective study comparing Bipolar Transurethral Resection of the Prostate (TURP) and Bipolar Enucleation of the Prostate (BipoLEP) for BPH, specifically focusing on prostates between 30-80 grams:
Study Title: A Prospective Randomized Controlled Trial Comparing Bipolar TURP and Bipolar Enucleation of the Prostate for Benign Prostatic Hyperplasia (BPH) with Prostate Volumes between 30-80 grams
1\. Introduction
Background: Briefly introduce Benign Prostatic Hyperplasia (BPH), its prevalence, and the associated lower urinary tract symptoms (LUTS). Highlight the common surgical interventions: TURP and, more recently, enucleation techniques.
Problem Statement: State that while both bipolar TURP and BipoLEP are established treatments, there's a need for a direct comparison, especially for moderate-sized prostates (30-80g). There's an ongoing debate regarding which approach offers superior outcomes and a better balance of efficacy and safety.
Rationale: Explain why this study is necessary. This can be because there is limited direct
Primary Objective: To compare the International Prostate Symptom Score (IPSS) at 12 months post-surgery between Bipolar TURP and BipoLEP in men with BPH and prostate volumes between 30-80 grams.
Secondary Objectives:
To compare perioperative outcomes including:
Operative time (minutes)
Catheterization time (days)
Length of hospital stay (days)
Blood loss (change in hemoglobin)
Requirement of blood transfusion
Incidence of perioperative complications (e.g., TUR syndrome, bleeding, infection, clot retention)
To compare postoperative functional outcomes including:
Peak urinary flow rate (Qmax) at 3, 6, and 12 months
Post-void residual (PVR) volume at 3, 6, and 12 months
Quality of life (QoL) using a validated questionnaire at 3, 6, and 12 months
To compare the incidence of postoperative complications including:
Urinary tract infection (UTI)
Urinary incontinence (UI)
Urethral stricture
Bladder neck contracture
Need for re-operation within 12 months.
To compare overall patient satisfaction using a visual analog scale (VAS) at 3, 6, and 12 months
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?: