This randomized double_blind clinical trial study will be done in evaluating the effect of diltiazem(an Antihypertensive drug) in treatment of post prostatectomy OAB. Men with the age of 65 to 85 undergone prostatectomy in the last month, suffering OAB right now after signing the agreement paper, enter the study.Patients with hypotension, heart failure, bradicardia and history of radiation therapy or BCG therapy will be excluded. We have 80 patients in two groups, first group gives diltiazem and second one takes tolterodine. Patients use one of the drugs for one month. Before prescription and one month after using the drug frequency, urgency and nocturia, will be documented based on International Prostate Symtom Score (I-PSS). At the end data will be processed in two groups by SPSS 16.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105096424N1
Registration date:2011-06-11, 1390/03/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-06-11, 1390/03/21
Registrant information
Name
Akbar Heidaripoor
Name of organization / entity
Kermanshah University of medical science
Country
Iran (Islamic Republic of)
Phone
+98 83 1835 6469
Email address
dr.ak.heidaripoor@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kermanshah university of medical science
Expected recruitment start date
2011-05-31, 1390/03/10
Expected recruitment end date
2012-05-30, 1391/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of tolterodine and diltiazem effects on OAB after prostatectomy
Public title
Diltiazem effects on overactive bladder syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients between 65 to 85 years old; with the history of prostatectomy in Emamreza Hospital; suffering OAB; agreement for enter to study.
Exclusion criteria: Having systolic blood pressure under 90; bradicardia; congestive heart failure; bladder cancer; history of bladder radiation; interavesical BCG therapy.
Age
From 65 years old to 85 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics coٍmmittee, ٍKermanshah university of medical science
Street address
Shahidbeheshti boulevard
City
Kermanshah
Postal code
6714673159
Approval date
2011-03-14, 1389/12/23
Ethics committee reference number
2000308/420/7/پ
Health conditions studied
1
Description of health condition studied
Overactive bladder syndrome
ICD-10 code
n32.8
ICD-10 code description
other specified disorders of bladder
Primary outcomes
1
Description
Patients symptoms of OAB
Timepoint
First of trial and one month later
Method of measurement
Questions of patients
Secondary outcomes
1
Description
Side effects
Timepoint
First of trial and one month later
Method of measurement
Questions from patients
2
Description
Blood pressure
Timepoint
First of trial and one month later
Method of measurement
Blood pressure measurement mmhg
Intervention groups
1
Description
Intervention group gives 60mg diltiazem oral tablet twice daily for one month.
Category
Treatment - Drugs
2
Description
Control group gives 2mg tolterodine oral tablet twice daily for one month.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emamreza Hospital
Full name of responsible person
Akbar Heidaripoor
Street address
Parastar boulevard
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, kermanshah university of medical science
Full name of responsible person
Dr. Reza Khodarahmi
Street address
Number2 building, Shahidbeheshti boulevard
City
Kermanshah
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, kermanshah university of medical science
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
Kermanshah university of medical science
Full name of responsible person
Akbar Heidaripoor
Position
Urology resident
Other areas of specialty/work
Street address
Emamreza hospital, Parastar boulevard
City
Kermanshah
Postal code
Phone
+98 83 1427 6309
Fax
Email
dr.ak.heidaripoor@kums.ac.ir; omid8772@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah university of medical science
Full name of responsible person
Akbar Heidaripoor
Position
Medical Doctor
Other areas of specialty/work
Street address
Emamreza hospital, Parastar boulevard
City
Kermanshah
Postal code
Phone
+98 83 1427 6309
Fax
Email
dr.ak.heidaripoor@kums.ac.ir; omid8772@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah university of medical science
Full name of responsible person
Akbar Heidaripoor
Position
Urology resident
Other areas of specialty/work
Street address
Emamreza hospital, Parastar boulevard
City
Kermanshah
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)