The aim of this study is to evaluate of efficacy and complications of prostatic arterial embolization in the treatment of BPH Benign prostate hyperplasia. Inclusion criteria: Men aged over 60 years having benign prostatic hyperplasia, no respond to medical treatment after 6 months, having sexual dysfunction, having maximum flow rate (Qmax) less than 12 mm/s in urine flowmeter. Exclusion criteria: malignancy and tortuosity atherosclerotic Iliac artery, having any indication for renal surgery such as hematuria, bladder diverticula, stones, etc. Symptomatic patients who have been treated by other clinical methods at least 6 months but their treatment was not satisfied are elected to this method. The estimated sample size will be 12 people. Then pelvic angiography is done to evaluate prostate artery. Total time of the procedure is measured from femoral artery puncture until bring out the catheter. Clinical success is considered to be a decrease in International Prostate Symptom Score IPSS<20 and improve Qmax>7ml/s.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015100318457N2
Registration date:2016-06-16, 1395/03/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-06-16, 1395/03/27
Registrant information
Name
Hossein Ghanaati
Name of organization / entity
Advanced Diagnostic and Interventional Radiology Research Center (ADIR), Tehran University of Medica
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 1516
Email address
ghenaati@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2015-11-22, 1394/09/01
Expected recruitment end date
2017-05-22, 1396/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of efficacy and complications of prostatic arterial embolization in the treatment of BPH
Public title
treatment of enlargement of prostatic by Closing the feeder vessels
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Men aged over 60 years having benign prostatic hyperplasia; no respond to medical treatment after 6 months, having sexual dysfunction, having maximum flow rate (Qmax) less than 12 mm/s in urine; ؛;acute urinary retention . Exclusion criteria: malignancy; tortuosity and atherosclerotic iliac artery; having any indication for renal surgery such as hematuria, bladder diverticula, stones
Age
From 55 years old to 35 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
12
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
Tehran University of Medical Sciences
Street address
Ghods street- Keshavarz Bulivar
City
Tehran
Postal code
Approval date
2015-05-21, 1394/02/31
Ethics committee reference number
IR.TUMS.REC.1394-211
Health conditions studied
1
Description of health condition studied
Benign Prostatic Hyperplasia
ICD-10 code
N40
ICD-10 code description
Hyperplasia of Prostate
Primary outcomes
1
Description
Q max
Timepoint
befor intrvention and 1,3,6 months after intervention
Method of measurement
uroflowmetry
2
Description
IPSS
Timepoint
befor intrvention and 1,3,6 months after intervention
Method of measurement
Questionnaire
3
Description
Prostat size
Timepoint
befor intrvention and 1,3,6 months after intervention
Method of measurement
Sonography
4
Description
PSA level
Timepoint
befor intrvention and 1,3,6 months after intervention
Method of measurement
lab
Secondary outcomes
1
Description
contrast media side effectS
Timepoint
during procedure and after 24 hours
Method of measurement
question from patient and clinical examination
2
Description
sexual dysfunction
Timepoint
6 months after surgery
Method of measurement
question from patients
3
Description
dont response to embolization and need to surgery
Timepoint
after 6 months
Method of measurement
question from patients
Intervention groups
1
Description
Prostatic Artery Embolization using polyvinyl guided by Angiographic catheter into the artery of the Prostate
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Medical Imaging Center
Full name of responsible person
Nafiseh Ghavami
Street address
Emem Khomeini Hospital- Medical Imaging Center
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mrs Akbari
Street address
Ghods Streer, Keshavarz Bulivar
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
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
Advanced And Inteventional Radiology Research Center
Full name of responsible person
Amir Hossein Jalali
Position
General Practitioner
Other areas of specialty/work
Street address
Emem Khomeini Hospital-Medical Imaging Center
City
Tehran
Postal code
Phone
+98 21 6658 1579
Fax
Email
Amirjalali51@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Medical Imaging Center
Full name of responsible person
Dr Hossein Ghanaati
Position
Radiology Professor
Other areas of specialty/work
Street address
Emam Khomeini Hospital
City
Tehran
Postal code
Phone
+66 581516
Fax
Email
ghanaati@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Advanced And Interventional Radiology Research Center
Full name of responsible person
Nafiseh Ghavami
Position
Ms/Expert Research
Other areas of specialty/work
Street address
City
Postal code
Phone
+98 21 6658 1579
Fax
Email
ghavami_7@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)