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

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:
  • transrectal ultrasound

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.

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

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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