Standardization of Prostatic Resection by Virtual Computational Reconstruction and Computational Flow Dynamics

Completed

• Conditions: Prostatic Diseases; Prostate Hyperplasia; Voiding Disorders
• Interventions: Diagnostic Test: Computational fluid dynamics (CFD)

• Registration Number: NCT05941260
• Lead Sponsor: Ain Shams University

Brief Summary

The enlargement of the prostate is responsible for voiding dysfunction in men, and especially elderly men. The primary surgical treatment for symptomatic benign prostatic hypertrophy (BPH) was transurethral resection of the prostate (TURP).

However, current resection techniques are predominantly experience-based and judgment-based, with little evidence to support the most effective portion of the prostate to be respected. So, the investigators plan through the study to construct a flow diagram to evaluate the amount of tissue needed to be resected to improve voiding flow dynamics.

Detailed Description

Benign prostatic hyperplasia (BPH) is an enlargement of the prostate gland that develops in men and is a common cause of voiding dysfunction in elderly patients. It is a major public health concern, causing high morbidity and substantial worsening of men's quality of life. (QOL)

Transurethral resection of the prostate (TURP) is the standard surgical therapy for obstructive prostatic hypertrophy. Various techniques have been suggested for the systematic removal of the adenomatous tissue, all based on the principle that the resection should be done stepwise as bleeding is the surgeon's major problem, leading to loss of visual field and disorientation, it is imperative that resection and hemostasis should both be completed in one area of the prostatic fossa before the next area is tackled. With the development of new techniques for prostate resection that decreases perioperative morbidity, larger sizes of the prostate are being resected, and a new category of patients is considered eligible for such an intervention with a large prostate size of more than 80 gm. However, current resection techniques are predominantly experience-based and judgment-based, with little evidence to support the most effective portion of the prostate to be resected to give us the best voiding outcome postoperative. So, the investigators plan through this study to construct a flow diagram to evaluate the amount of tissue needed to be resected to improve voiding flow dynamics.

Study Timeline

• Study First Submitted: 2023-07-03
• Study First Submitted QC: 2023-07-03
• Study First Posted: 2023-07-12
• Study Start: 2023-07-15
• Primary Completion: 2023-07-30
• Study Completion: 2023-08-15
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-04
• Last Update Posted: 2024-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 15

Inclusion Criteria

• Age: above 50 years old, undergoing an elective endo-urological procedure

Exclusion Criteria

1. Neurogenic bladder
2. Previous prostate or urethral surgery
3. Associated urethral stricture

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Male patients above the age of 50	Computational fluid dynamics (CFD)	All male patients aged 50 or more with benign prostatic hyperplasia who are scheduled for any planned endourological procedure will be included in our study. * Routine cystourethroscopy is a standard procedure in any endourological procedure, whatever the type of procedure. * With advanced imaging technology, it is possible through 3D scanning processes of analyzing photos and videos and digitally defining depth, to create 3D models of the tissues and channels, from endoscopy videos. * We are going to record this diagnostic cysto-urethroscopy of all patients, and we will send these videos for pre-processing and analysis by virtual computational reconstruction, so that an accurate model could be constructed with a digital model of the urethra geometry and a numerical model of the flow inside the urethra.

Primary Outcome Measures

Name	Time	Method
computerized urodynamic module of the male urethra	1 month from the time of video recording during surgery.	Is to formulate a computerized urodynamic module to simulate the bladder-urethral passage, evaluate urine flow, and predict the amount of needed tissue to be resected to improve patient voiding by a computerized module.

Trial Locations

Locations (1)

Ahmed Maher; 🇪🇬 Cairo, Egypt