- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04352257
Bladder and Prostate Sonomorphology in Patients With Symptomatic Benign Prostatic Hyperplasia
April 17, 2020 updated by: Diaa Eldin Taha Ramadan Mohamed, Kafrelsheikh University
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?
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Bladder and Prostate Sonomorphology as a Useful tool for Detecting Bladder Outlet Obstruction in Patients With Symptomatic Benign Prostatic Hyperplasia?
Study Type
Observational
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kafrelsheikh
-
Kafr Ash Shaykh, Kafrelsheikh, Egypt
- Recruiting
- Kafrelsheikh faculty of medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
48 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Probability Sample
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.
Description
Inclusion Criteria:
male patients with LUTS/BPH prostate size > 25 g
Exclusion Criteria:
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
ultrasonography
pelvic and transrectal ultrasound
|
pelvic and transrectal ultrasound
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pelvic and transrectal ultrasound
Time Frame: 18 months
|
bladder wall thickness, prostate volume, and prostate morphology
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pelvic and transrectal ultrasound in relation to pressure flow study
Time Frame: 18 months
|
correlation of the pelvic and transrectal ultrasound parameters to pressure flow study measurements
|
18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2019
Primary Completion (Anticipated)
April 1, 2021
Study Completion (Anticipated)
April 1, 2021
Study Registration Dates
First Submitted
April 12, 2020
First Submitted That Met QC Criteria
April 17, 2020
First Posted (Actual)
April 20, 2020
Study Record Updates
Last Update Posted (Actual)
April 20, 2020
Last Update Submitted That Met QC Criteria
April 17, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RS/19.21
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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