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

NCT05941260 | Completed

• 1 other identifier: R1131/2023
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Hyperplasia; Prostatic Diseases; Voiding Disorders

Outcome Measures

Primary Outcomes (1)

• computerized urodynamic module of the male urethra

  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.

  1 month from the time of video recording during surgery.

Study Arms (1)

Male patients above the age of 50

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.

Diagnostic Test: Computational fluid dynamics (CFD)

Interventions

Computational fluid dynamics (CFD) DIAGNOSTIC_TEST

\- Video recording starts in an antegrade manner starting from the bladder neck through the prostatic urethra and ends after the verumontanum at the external sphincter. Videos were taken with a very slow movement of the endoscope to ensure the sharpness of the data and to prevent complications in post-processing. The focal length and zoom of the endoscope camera were set at the beginning and maintained throughout the capturing, while the angle of the lens changes to capture the widest field possible for each targeted area. * Computational fluid dynamics (CFD) can then be used to numerically model the behavior of the flow inside the urethra by solving the governing equations of the flow using the finite volume method. * Through which we can develop a urodynamic computer model to simulate the bladder-urethral passage and predict the success of the resection undertaken by the surgeon. No extra intervention will be provided to our patients apart from their routine surgery.

Male patients above the age of 50

Eligibility Criteria

• Age: 50 Years+
• Gender Eligibility Details: all male patients aged above 50 with enlarged prostate who will undergo endoscopic surgical intervention for any urological disease will be included in our study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

all male patients above the age of 50 years old with an enlarged prostate and undergoing any endourological procedure with perform cystoscopy during the standard endoscopic procedure. 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 then digitally defining the depth, to create 3D models of the tissues and channels, from endoscopy videos.

You may qualify if:

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

You may not qualify if:

• Neurogenic bladder
• Previous prostate or urethral surgery
• Associated urethral stricture

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ahmed Maher

Cairo, 11757, Egypt

Location

MeSH Terms

Conditions

Prostatic Hyperplasia; Prostatic Diseases

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: July 3, 2023
• First Posted: July 12, 2023
• Study Start: July 15, 2023
• Primary Completion: July 30, 2023
• Study Completion: August 15, 2023
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

EG (1)