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CompletedNCT05941260Updated May 8, 2024

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

An observational study in Prostate Hyperplasia, Prostatic Diseases and Voiding Disorders, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to male participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2024-05-08.

Sponsored by Ain Shams University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
15
Ages
50 Years and older
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Prostate Hyperplasia
  • Prostatic Diseases
  • Voiding Disorders
03

In context

Prostatic Hyperplasia

827 studies on the registry are indexed under Prostatic Hyperplasia; 179 are open to participants now.

This study's enrollment of 15 is below the median of 250 across 177 observational studies indexed under Prostatic Hyperplasia.

Browse Prostatic Hyperplasia studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.

Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Neurogenic bladder
  2. Previous prostate or urethral surgery
  3. Associated urethral stricture
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
15 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testComputational 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.

06

What researchers measure

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.

    Time frame: 1 month from the time of video recording during surgery.

07

Study locations

1 site
  • Ahmed Maher
    Cairo, 11757, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05941260
Responsible party
Ahmed Maher Gamil Ahmed Higazy (principle investigator, Ain Shams University) — Principal investigator
First posted
Jul 12, 2023
Start date
Jul 15, 2023
Primary completion
Jul 30, 2023
Completion
Aug 15, 2023
Last update
May 8, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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