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Bladder and Prostate Sonomorphology in Patients With Symptomatic Benign Prostatic Hyperplasia

Sponsor
Kafrelsheikh University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04352257
Collaborator
(none)
200
Enrollment
1
Location
24
Anticipated Duration (Months)
8.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Bladder and Prostate Sonomorphology in Patients With Symptomatic Benign Prostatic Hyperplasia?

Condition or Disease Intervention/Treatment Phase
  • Radiation: pelvic Ultrasound

Detailed Description

Bladder and Prostate Sonomorphology as a Useful tool for Detecting Bladder Outlet Obstruction in Patients With Symptomatic Benign Prostatic Hyperplasia?

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Bladder and Prostate Sonomorphology as a Useful Tool for Detecting Bladder Outlet Obstruction in Patients With Symptomatic Benign Prostatic Hyperplasia
Actual Study Start Date :
Apr 1, 2019
Anticipated Primary Completion Date :
Apr 1, 2021
Anticipated Study Completion Date :
Apr 1, 2021

Arms and Interventions

Arm Intervention/Treatment
ultrasonography

pelvic and transrectal ultrasound

Radiation: pelvic Ultrasound
pelvic and transrectal ultrasound
Other Names:
  • transrectal ultrasound

    		•

    Outcome Measures

    Primary Outcome Measures

    1. pelvic and transrectal ultrasound [18 months]

      bladder wall thickness, prostate volume, and prostate morphology

    Secondary Outcome Measures

    1. pelvic and transrectal ultrasound in relation to pressure flow study [18 months]

      correlation of the pelvic and transrectal ultrasound parameters to pressure flow study measurements

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kafrelsheikh faculty of medicine Kafr Ash Shaykh Kafrelsheikh Egypt

    Sponsors and Collaborators

    • Kafrelsheikh University

    Investigators

    • Principal Investigator: Diaa Eldin Taha, MD, Lecturer of urology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Diaa Eldin Taha Ramadan Mohamed, Lecturer of urology, Kafrelsheikh University
    ClinicalTrials.gov Identifier:
    NCT04352257
    Other Study ID Numbers:
    • RS/19.21
    First Posted:
    Apr 20, 2020
    Last Update Posted:
    Apr 20, 2020
    Last Verified:
    Apr 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Prostatic Hyperplasia
    Hyperplasia

    Study Results

    No Results Posted as of Apr 20, 2020