The purpose of this double blind randomized clinical trial was to study about therapeutic effect of desmopressin in the treatment of nocturia comparing with placebo. A total of 60 men with nocturia were recruited and randomly assigned to receive desmopressin 0.1mg orally at bedtime or placebo 0.1mg orally at bedtime for 8 weeks. Nocturnal voiding frequency and adverse effects were measured and compared between groups. Primary outcome was nocturnal voiding frequency and secondary outcome was drug adverse effects.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201010234989N1
Registration date:2011-03-15, 1389/12/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-03-15, 1389/12/24
Registrant information
Name
Bijan Rezakhaniha
Name of organization / entity
I.R.I Army University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2255 7435
Email address
bi_rezakhaniha@armyums.ac.ir
Recruitment status
Recruitment complete
Funding source
I.R.I Army University of Medical Sciences
Expected recruitment start date
2009-04-04, 1388/01/15
Expected recruitment end date
2011-04-04, 1390/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study Of Therapeutic Effect Of Desmopressin In The Treatment Of Nocturia In The Patients Who Refeered To Urology Ward Of 501 I.R.I Army Hospital
Public title
Study Of Therapeutic Effect Of Desmopressin In The Treatment Of Nocturia In The Patients Who Referred To Urology Ward Of 501 I.R.I Army Hospital
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Nocturnal voiding at least 2 times or more
Exclusin criteria: Drug noncompliance, uncontrolled diabetes mellitus, decompensated heart failure, Neurogenic bladder, Diabetes insipidus
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
I.R.I Army University of Medical Sciences
Street address
I.R.I Army University of Medical Sciences, Etemad Zade Street, West Fatemi Street
City
Tehran
Postal code
Approval date
2009-02-19, 1387/12/01
Ethics committee reference number
1545
Health conditions studied
1
Description of health condition studied
Nocturia
ICD-10 code
R35
ICD-10 code description
Nocturia
Primary outcomes
1
Description
Nocturnal Voiding Frequency
Timepoint
Before intervention, 4 weeks after intervention, 8 weeks after intervention
Method of measurement
Interview with patient
Secondary outcomes
1
Description
Drug Adverse Effects
Timepoint
Before intervention, 4 weeks after intervention, 8 weeks after intervention
Method of measurement
Interview with patient
Intervention groups
1
Description
Intervention Group: Desmopressin, 0.1mg, orally, at bed time for 8 weeks
Category
Treatment - Drugs
2
Description
Control Group: Placebo, 0.1mg, orally, at bed time for 8 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Urology Ward Of 501 I.R.I Army Hospital
Full name of responsible person
Dr Bijan Rezakhaniha
Street address
501 I.R.I Army Hospital, Etemad Zade Street, West Fatemi Street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
I.R.I Army University of Medical Sciences
Full name of responsible person
Dr Bijan Rezakhaniha
Street address
I.R.I Army University of Medical Sciences, Etemad Zade Street, West Fatemi Street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
I.R.I Army 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
I.R.I Army University of Medical Sciences
Full name of responsible person
Dr Bijan Rezakhaniha
Position
Urologist-Assistant Professor
Other areas of specialty/work
Street address
I.R.I Army University of Medical Sciences, Etemad Zade Street, West Fatemi Street
City
Tehran
Postal code
Phone
+98 21 2255 7435
Fax
+98 21 2255 7435
Email
reza.bijan@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
I.R.I Army University of Medical Sciences
Full name of responsible person
Dr Bijan Rezakhaniha
Position
Urologist-Assistant Professor
Other areas of specialty/work
Street address
I.R.I Army University of Medical Sciences, Etemad Zade Street, West Fatemi Street
City
Tehran
Postal code
Phone
+98 21 2255 7435
Fax
+98 21 2255 7435
Email
reza.bijan@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
I.R.I Army University of Medical Sciences
Full name of responsible person
Dr Bijan Rezakhaniha
Position
Urologist-Assistant Professor
Other areas of specialty/work
Street address
I.R.I Army University of Medical Sciences, Etemad Zade Street, West Fatemi Street
City
Tehran
Postal code
Phone
+98 21 2255 7435
Fax
+98 21 2255 7435
Email
reza.bijan@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)