Bladder and Prostate Sonomorphology in Patients With Symp... | NCT04352257

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

NCT04352257

Sponsor

Kafrelsheikh University

Status

Unknown status

Last Update Posted

Apr 20, 2020Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Benign Prostatic Hyperplasia

Interventions

pelvic Ultrasound

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2019Actual

Primary Completion Date

Apr 1, 2021Estimated

Completion Date

Apr 1, 2021Estimated

First Submitted Date

Apr 12, 2020

First Submission Date that Met QC Criteria

Apr 17, 2020

First Posted Date

Apr 20, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 17, 2020

Last Update Posted Date

Apr 20, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Diaa Eldin Taha Ramadan Mohamed, Lecturer of urology, Kafrelsheikh UniversityPrincipal Investigator

Lead Sponsor

Kafrelsheikh UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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?

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

12 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ultrasonography		pelvic and transrectal ultrasound	Radiation: pelvic Ultrasound

Interventions

Name	Type	Description	Arm Group Labels	Other Names
pelvic Ultrasound	Radiation	pelvic and transrectal ultrasound	ultrasonography

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pelvic and transrectal ultrasound	bladder wall thickness, prostate volume, and prostate morphology	18 months

Secondary Outcomes

Measure	Description	Time Frame
pelvic and transrectal ultrasound in relation to pressure flow study	correlation of the pelvic and transrectal ultrasound parameters to pressure flow study measurements	18 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Diaa Eldin Taha, MD	Contact	01008531384		drdiaaeldin@gmail.com

Overall Officials

Name	Affiliation	Role
Diaa Eldin Taha, MD	Lecturer of urology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kafrelsheikh faculty of medicine	Recruiting	Kafr ash Shaykh	Kafrelsheikh		Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011470	Prostatic Hyperplasia

Ancestor Terms

ID	Term
D011469	Prostatic Diseases
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D036761	Ultrasound, High-Intensity Focused, Transrectal

Ancestor Terms

ID	Term
D057086	High-Intensity Focused Ultrasound Ablation
D014464	Ultrasonic Therapy
D003972	Diathermy
D006979	Hyperthermia, Induced

Browse Leaves

Not provided

Browse Branches

Not provided