Prostate HyperplasiaNCT05941260
Standardization of Prostatic Resection by Virtual Computational Reconstruction and Computational Flow Dynamics
An observational study of Prostate Hyperplasia and Prostatic Diseases, run by Ain Shams University at 1 site in Egypt.
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). Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Prostate Hyperplasia, Prostatic Diseases, Voiding Disorders
- What is being tested?
- Computational fluid dynamics (CFD)
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jul 2023to 15 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age: above 50 years old, undergoing an elective endo-urological procedure
Who cannot join
- Neurogenic bladder
- Previous prostate or urethral surgery
- Associated urethral stricture
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Standardization of Prostatic Resection Operative Techniques by Virtual Computational Reconstruction and Computational Flow Dynamics
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.
- Conditions
- Prostate Hyperplasia, Prostatic Diseases, Voiding Disorders
- Being tested
- Computational fluid dynamics (CFD)
- Medical subject headings
- Prostatic Hyperplasia, Prostatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Computational fluid dynamics (CFD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month from the time of video recording during surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start15 Jul 2023
- Primary completion30 Jul 2023
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate HyperplasiaStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Maher Gamil Ahmed Higazy, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05941260
- Sponsor's protocol ID
- R1131/2023
- Status last verified
- May 2024
- First submitted
- 3 Jul 2023
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standardization of Prostatic Resection Operative Techniques by Virtual Computational Reconstruction and Computational Flow Dynamics
- ClinicalTrials.gov ID
- NCT05941260
- Acronym / sponsor ID
- R1131/2023
- Conditions
- Prostate Hyperplasia, Prostatic Diseases, Voiding Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Jul 2023 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 12 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Male patients above the age of 50 | – | Diagnostic Test: 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Age: above 50 years old, undergoing an elective endo-urological procedure
Key exclusion criteria (3 listed)
- Neurogenic bladder
- Previous prostate or urethral surgery
- Associated urethral stricture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | Male patients above the age of 50 |
Primary outcome
computerized urodynamic module of the male urethra
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Hyperplasia and Prostatic Diseases, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
computerized urodynamic module of the male urethra (time frame: 1 month from the time of video recording during surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.