Protocol summary

Summary
This study aimed to compare ultrasonography and uroflowmetry index in recognition of bladder outlet obstruction due to benign prostatic hyperplasia. In this descriptive cross sectional study (diagnosis), 250 patients with lower urinary tract symptoms due to benign prostatic hyperplasia referred to the urology clinic of Razi Hospital in Rasht, will be enrolled. Patients with a history of surgery for prostate and urinary tract will be excluded. Patients' information including age, irritation and obstructive symptoms of bladder (dysuria, urinary frequency, daily, urgency of urination, nocturia, straining to urinate, incomplete emptying of the bladder, reducing the pressure and urine diameter, delay in starting the urine, intermittency), urinary incontinence and acute urinary retention in the form of a standard questionnaire (International Prostate Symptom Score (IPSS)) will be recorded. All patients will undergo ultrasonography and uroflowmetery in term of diagnosis of bladder outlet obstruction. Prostate volume; urinary residue; detrusor thickness and median lobes will be measured will be measured by transabdoinal ultrasonography. Patients will place in three ranges in terms of maximum urinary flow rate (Qmax): Qmax of less than 10 ml per second (symptomatic bladder outlet obstruction), Qmax of less than 10 ml per second and greater than 15 ml per second (equivocal), Qmax greater than 15 ml per second (normal).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016022326718N1
Registration date: 2016-05-11, 1395/02/22
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-05-11, 1395/02/22
Registrant information
Name
Hamidreza Nasseh
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3352 5259
Email address
nasseh_hamid@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Urology Research Center, Guilan University of Medical Sciences
Expected recruitment start date
2015-08-25, 1394/06/03
Expected recruitment end date
2016-08-24, 1395/06/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of ultrasonography and uroflowmetry index in diagnosis of bladder outlet obstruction in patients with lower urinary tract symptom due to benign prostatic hyperplasia
Public title
Comparison of ultrasonography and uroflowmetry in diagnosis of bladder outlet obstruction due to benign prostatic hyperplasia
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: patients peresenting with lower urinary tract symptom (LUTS) due to benign prostate hyperplasia (BPH) Exclusion criteria: history of prostatitis; urinary tract surgery; trauma; Urethritis; urinary stone passage; Catheterization; abnormal prostate specific antigene (PSA) and digital rectal exam (DRE); BPH surgical criterias; Neurogenic bladder
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 250
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Opposite Sepah Bank, Western Shahid Beheshti Blvd., Gaz Square
City
Rasht
Postal code
41938-93345
Approval date
2015-08-24, 1394/06/02
Ethics committee reference number
IR.GUMS.REC.1394.212

Health conditions studied

1

Description of health condition studied
Bladder outlet obstruction
ICD-10 code
N32.0
ICD-10 code description
Bladder-neck obstruction

Primary outcomes

1

Description
Prostate volume
Timepoint
During hospitalization
Method of measurement
Ultrasonography

2

Description
Urine residue
Timepoint
During hospitalization
Method of measurement
Ultrasonography

3

Description
Bladder wall thickness
Timepoint
During hospitalization
Method of measurement
Ultrasonography

4

Description
Intravesical protrusion of prostate
Timepoint
During hospitalization
Method of measurement
Ultrasonography

5

Description
Qmax
Timepoint
During hospitalization
Method of measurement
Uroflowmetery

6

Description
International Prostate Symptom Score
Timepoint
During hospitalization
Method of measurement
Based on a standard questionnaire with scores of 0 to 35

7

Description
Prostate specific antigen
Timepoint
During hospitalization
Method of measurement
Blood test

Secondary outcomes

empty

Intervention groups

1

Description
Abdominal ultrasonography
Category
Diagnosis

2

Description
Uroflowmetery
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Dr. Sahand Omidi (Resident)
Street address
Sardar Jangal Street, Razi hospital
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Urology Research Center
Full name of responsible person
Dr. Siavsh Falahatkar
Street address
Sardar Jangal Street, Razi hospital, Urology Research Centre
City
Rasht
Grant name
10506
Grant code / Reference number
32
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Urology Research Center
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Urology Research Center
Full name of responsible person
Dr. Sahand Omidi
Position
Co worker/Resident
Other areas of specialty/work
Street address
Urology Research Center, Razi Hospital, Sardar Jangal Street
City
Rasht
Postal code
41448-95655
Phone
+98 13 3352 5259
Fax
+98 13 3352 5259
Email
urc1384@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Urology Research Center
Full name of responsible person
Dr. Hamidreza Nasseh
Position
Associated Professor of Urology
Other areas of specialty/work
Street address
Urology Research Center, Razi Hospital, Sardar Jangal Street
City
Rasht
Postal code
41448-95655
Phone
+98 13 3352 5259
Fax
+98 13 3352 5259
Email
nasseh_hamid@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Urology Research Center
Full name of responsible person
Dr. Sahand Omidi
Position
Co worker/Resident
Other areas of specialty/work
Street address
Urology Research Center, Razi Hospital, Sardar Jangal Street
City
Rasht
Postal code
41448-95655
Phone
00
Fax
Email
urc1384@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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