Benign Prostatic HyperplasiaNCT04352257
Bladder and Prostate Sonomorphology in Patients With Symptomatic Benign Prostatic Hyperplasia
An observational study of Benign Prostatic Hyperplasia, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
Bladder and Prostate Sonomorphology in Patients With Symptomatic Benign Prostatic Hyperplasia? Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- pelvic Ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2019to 1 Apr 2021
- How long will I take part?
- 12 Months
- 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: patient more than 50 year old who were presented with Lower urinary tract symptoms.The patients were be subjected to pelvic and transrectal ultrasound.
Who may be able to join
- male patients with LUTS/BPH prostate size > 25 g
Who cannot join
- urinary retention diabetes mellitus neurologic deficit LUTS medications prior lower urinary tract surgery concomitant bladder pathology small bladder capacity (< 150 ml) urethral stricture evident prostate carcinoma.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Kafrelsheikh faculty of medicine
Kafr ash Shaykh, Kafrelsheikh
Diaa ELDIN Taha, MD, 01008531384, drdiaaeldin@gmail.com
About this study
Official title: Bladder and Prostate Sonomorphology as a Useful Tool for Detecting Bladder Outlet Obstruction in Patients With Symptomatic Benign Prostatic Hyperplasia
Bladder and Prostate Sonomorphology in Patients With Symptomatic Benign Prostatic Hyperplasia?
Read the detailed description
Bladder and Prostate Sonomorphology as a Useful tool for Detecting Bladder Outlet Obstruction in Patients With Symptomatic Benign Prostatic Hyperplasia?
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- pelvic Ultrasound
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pelvic UltrasoundRadiation
Also called transrectal ultrasound
pelvic and transrectal ultrasound
| Study group | Role | What they receive |
|---|---|---|
| ultrasonography | pelvic and transrectal ultrasound Receives: Radiation: pelvic Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
pelvic and transrectal ultrasound
bladder wall thickness, prostate volume, and prostate morphology
Measured: 18 months
Secondary outcomes (1)
pelvic and transrectal ultrasound in relation to pressure flow study
correlation of the pelvic and transrectal ultrasound parameters to pressure flow study measurements
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start1 Apr 2019
- Primary completion1 Apr 2021 (estimated)
- Study completion1 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- 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
- 200 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diaa Eldin Taha Ramadan Mohamed, Kafrelsheikh University
- Investigators
- Diaa Eldin Taha, MD, Principal investigator, Lecturer of urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04352257
- Sponsor's protocol ID
- RS/19.21
- Status last verified
- Apr 2020
- First submitted
- 12 Apr 2020
- Last updated
- 20 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bladder and Prostate Sonomorphology as a Useful Tool for Detecting Bladder Outlet Obstruction in Patients With Symptomatic Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT04352257
- Acronym / sponsor ID
- RS/19.21
- Conditions
- Benign Prostatic Hyperplasia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 1 Apr 2021 (estimated)
- First posted
- 20 Apr 2020 (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.
Bladder and Prostate Sonomorphology in Patients With Symptomatic Benign Prostatic Hyperplasia?
Detailed description
Bladder and Prostate Sonomorphology as a Useful tool for Detecting Bladder Outlet Obstruction in Patients With Symptomatic Benign Prostatic Hyperplasia?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ultrasonography | – | Radiation: pelvic Ultrasoundpelvic and transrectal ultrasound |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient more than 50 year old who were presented with Lower urinary tract symptoms.The patients were be subjected to pelvic and transrectal ultrasound.
Key inclusion criteria (1 listed)
- male patients with LUTS/BPH prostate size > 25 g
Key exclusion criteria (1 listed)
- urinary retention diabetes mellitus neurologic deficit LUTS medications prior lower urinary tract surgery concomitant bladder pathology small bladder capacity (< 150 ml) urethral stricture evident prostate carcinoma.
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 |
|---|---|---|
| pelvic UltrasoundAlso: transrectal ultrasoundpelvic and transrectal ultrasound | Radiation | ultrasonography |
Primary outcome
pelvic and transrectal ultrasound
Time frame: 18 months
bladder wall thickness, prostate volume, and prostate morphology
1 secondary outcome
pelvic and transrectal ultrasound in relation to pressure flow study
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2020.
- Individual participant dataSharing planned: No
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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.
Diaa Eldin Taha, MD principal investigator
Lecturer of urology
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 Benign Prostatic Hyperplasia, run by Kafrelsheikh 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 1 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: status not confirmed, as of the sponsor's last update on 20 Apr 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diaa Eldin Taha, MD (01008531384, drdiaaeldin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pelvic and transrectal ultrasound (time frame: 18 months). 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 20 Apr 2020.