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

Prostate Hyperplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05941260
• Other study ID #: R1131/2023
• Status: Completed
• Start date: July 15, 2023
• Est. completion date: August 15, 2023

Study information

• Verified date: May 2024
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 15, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperplasia
• Prostate Hyperplasia
• Prostatic Diseases
• Prostatic Hyperplasia
• Voiding Disorders

Intervention

Diagnostic Test:
• Computational fluid dynamics (CFD)
- 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.

Locations

Country	Name	City	State
Egypt	Ahmed Maher	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.