NCT04352257

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

April 12, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 20, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

April 20, 2020

Status Verified

April 1, 2020

Enrollment Period

2 years

First QC Date

April 12, 2020

Last Update Submit

April 17, 2020

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

  • pelvic and transrectal ultrasound

    bladder wall thickness, prostate volume, and prostate morphology

    18 months

Secondary Outcomes (1)

  • pelvic and transrectal ultrasound in relation to pressure flow study

    18 months

Study Arms (1)

ultrasonography

pelvic and transrectal ultrasound

Radiation: pelvic Ultrasound

Interventions

pelvic UltrasoundRADIATION

pelvic and transrectal ultrasound

Also known as: transrectal ultrasound
ultrasonography

Eligibility Criteria

Age50 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • male patients with LUTS/BPH prostate size \> 25 g

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kafrelsheikh faculty of medicine

Kafr ash Shaykh, Kafrelsheikh, Egypt

RECRUITING

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Ultrasound, High-Intensity Focused, Transrectal

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

High-Intensity Focused Ultrasound AblationUltrasonic TherapyDiathermyHyperthermia, InducedTherapeuticsAblation TechniquesSurgical Procedures, OperativeProstatectomyUrologic Surgical Procedures, MaleUrologic Surgical ProceduresUrogenital Surgical Procedures

Study Officials

  • Diaa Eldin Taha, MD

    Lecturer of urology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Diaa Eldin Taha, MD

CONTACT

01008531384drdiaaeldin@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of urology

Study Record Dates

First Submitted

April 12, 2020

First Posted

April 20, 2020

Study Start

April 1, 2019

Primary Completion

April 1, 2021

Study Completion

April 1, 2021

Last Updated

April 20, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)