The effect of the ethanol injection in prostate tissue versus no injection for treatment of benign prostatic hyperplasia: a before after clinical trial
Objectives: To assess the effect of the ethanol injection in prostate tissue versus no injection for treatment of benign prostatic hyperplasia.
Design: A before after clinical trial.
Setting and conduct: All eligible patients with benign prostatic hyperplasia who will refer to Shahid Beheshti Hospital during the study period will be enrolled in to the trial.
Inclusion criteria: (a) patients with benign prostatic hyperplasia; (b) age of 40 years or older; (c) contraindication for prostatic surgery; (d) Unable to tolerate adverse effect of prostatic drug treatment; (e) prostatic surgery refusal.
Exclusion criteria: (a) history of prostatic surgery; (b) having prostatic cancer.
Intervention: injection of 10 to 20 ml alcohol 98% into prostatic tissue in 4 to 10 location.
Control: comparison with situation before intervention.
Primary outcome: (a) evaluation of urinary problem using International Prostatic Symptoms Scale-IPSS before surgery and 3 and 6 months later; (b) evaluation of maximum urine flow using Peak Flow Rate before surgery and 3 and 6 months later; (c) measuring the prostatic volume using ultrasonography before surgery and 3 and 6 months later; (d) measuring the remained urine volume using ultrasonography before surgery and 3 and 6 months later; (e) measuring the prostatic specific antigen (PSA) through blood sampling before surgery and 3 and 6 months later.
Secondary outcome: measuring the injection induced pain using visual analog scale (VAS) immediately after injection.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201407049014N39
Registration date:2014-07-04, 1393/04/13
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-07-04, 1393/04/13
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2014-07-23, 1393/05/01
Expected recruitment end date
2015-07-23, 1394/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of the ethanol injection in prostate tissue versus no injection for treatment of benign prostatic hyperplasia: a before after clinical trial
Public title
The effect of the ethanol injection in prostate tissue versus no injection for treatment of benign prostatic hyperplasia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (a) patients with benign prostatic hyperplasia; (b) age of 40 years or older; (c) contraindication for prostatic surgery; (d) Unable to tolerate adverse effect of prostatic drug treatment; (e) prostatic surgery refusal.
Exclusion criteria: (a) history of prostatic surgery; (b) having prostatic cancer.
Age
From 40 years old to 80 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
31
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Randomization: This trial will be run as a before-after design; hence no randomization will be done.
Blinding: This is an aggressive intervention; hence blinding is impossible.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethic Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2014-06-25, 1393/04/04
Ethics committee reference number
D/P/16/35/9/1541
Health conditions studied
1
Description of health condition studied
Benign Prostate Hyperplasia
ICD-10 code
N40
ICD-10 code description
Hyperplasia of prostate
Primary outcomes
1
Description
evaluation of urinary problem
Timepoint
before surgery and 3 and 6 months later
Method of measurement
using International Prostatic Symptoms Scale-IPSS
2
Description
evaluation of maximum urine flow
Timepoint
before surgery and 3 and 6 months later
Method of measurement
using Peak Flow Rate
3
Description
measuring the prostatic volume
Timepoint
before surgery and 3 and 6 months later
Method of measurement
using ultrasonography
4
Description
measuring the remained urine volume
Timepoint
before surgery and 3 and 6 months later
Method of measurement
using ultrasonography
5
Description
measuring the prostatic specific antigen (PSA)
Timepoint
before surgery and 3 and 6 months later
Method of measurement
through blood sampling
Secondary outcomes
1
Description
measuring the injection induced pain
Timepoint
immediately after injection
Method of measurement
using visual analog scale (VAS)
Intervention groups
1
Description
injection of 10 to 20 ml alcohol 98% into prostatic tissue in 4 to 10 location
Category
Treatment - Drugs
2
Description
comparison with situation before intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Dr Mohammad Reza Mojallali
Street address
Shahid Beheshti Hospital, Eram Bul.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research the Technology, Hamadan 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
Shahid Beheshti Hospital
Full name of responsible person
Dr Mohammad Reza Mojallali
Position
Resident of Urology
Other areas of specialty/work
Street address
Shahid Beheshti Hospital, Eram Bul.
City
Hamadan
Postal code
Phone
+98 81 3264 0021
Fax
Email
rezamojallal@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti Hospital
Full name of responsible person
Dr Sasan Mehrabi
Position
Urologist
Other areas of specialty/work
Street address
Shahid Beheshti Hospital, Eram Bul.
City
Hamadan
Postal code
Phone
+98 81 3264 0021
Fax
Email
mehrabi.sasan@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)