Protocol summary

Summary
Purpose : Comparison of effectiveness of tamsulosin combined with minirin and tamsulosin alone in treatment of BPH patients Inclusion and exclusion criteria : International prostatic symptom score more than 7 , 3 or more episodes of nocturia , abillity to providing time-urine volume chart were among the inclusion criteria . Surgical indication ,post voiding residue more than 200 cc , history of ischemic heart disease were the exclusion criteria . Method :354 patients with benign prostatic hyperplasia were randomized in to group A and B . Patients received tamsulosin plus minirin in group A and tamsulosin alone in group B . After 2 months , minirin was omitted from regimen of group A and added to regimen of group B .It continued for another 2 months . Patient were evaluated initially , 2 months and 4 months after study started respect to International Prostatic Symptom Score , nocturia , post voiding residue , peak flow rate , prostate volume , bladder wall thickness , nightly urine volume .Evaluations were done by sonography , uroflowmetry , time-voiding volume chart and International Prostatic Symptom Score questionnaire.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201205219819N1
Registration date: 2012-06-18, 1391/03/29
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-06-18, 1391/03/29
Registrant information
Name
Mohammadreza Nowroozi
Name of organization / entity
Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2764
Email address
uorc@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Urology Research Center of Tehran University of Medical ScienceFerring company
Expected recruitment start date
2009-03-21, 1388/01/01
Expected recruitment end date
2013-12-01, 1392/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effectivness of tamsulosin with and without minirin on lower urinary tract symptom of BPH in patient suitable for medical therapy
Public title
Effect of tamsulosin and minirin in treatment of BPH
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : Filling consent form ; IPSS more than 7 ; Nocturia more than 3 ; Ability of providing time-urinevolume chart Exclusion criteria : Not filling consent form ; Surgical indication ; History of ischemic heart disease ; Use of drugs like anti cholinergic , antisychotic , alpha blocker which can not be discontinued ; Contraindication to use tamsulosin and minirin ; If any side effect of drugs is present ; Cr more than 2 mg/dl ; PVR more than 200 cc
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 354
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciense
Street address
Qods st. , Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2012-05-20, 1391/02/31
Ethics committee reference number
90/د/130/2843

Health conditions studied

1

Description of health condition studied
Benign Prostatic Hyperplasia
ICD-10 code
N 40
ICD-10 code description
Hyperplasia of prostate

Primary outcomes

1

Description
International prostatic symptom score
Timepoint
Before intervention - 2 mounth after intervention - 4 mounth after intervention
Method of measurement
International prostatic symptom score Questionaire

2

Description
nocturia
Timepoint
Before intervention - 2 mounth after intervention - 4 mounth after intervention
Method of measurement
IPSS questionaire

3

Description
nocturnal volume
Timepoint
Before intervention - 2 mounth after intervention - 4 mounth after intervention
Method of measurement
urine volume - time chart

4

Description
post voiding residue
Timepoint
Before intervention - 2 mounth after intervention - 4 mounth after intervention
Method of measurement
trans abdominal sonography

5

Description
prostate volume
Timepoint
Before intervention - 2 mounth after intervention - 4 mounth after intervention
Method of measurement
trans abdominal sonography

6

Description
bladder wall thickness
Timepoint
Before intervention - 2 mounth after intervention - 4 mounth after intervention
Method of measurement
trans abdominal sonography

7

Description
peak flow rate
Timepoint
Before intervention - 2 mounth after intervention - 4 mounth after intervention
Method of measurement
uroflowmetry

Secondary outcomes

1

Description
Hyponatremia
Timepoint
befor intervention - 2 days and 7 days after study started
Method of measurement
serum Na

Intervention groups

1

Description
Tamsulosin 0.4 mg daily for 2 episode of 2 mounths
Category
Treatment - Drugs

2

Description
Minirin 0.2 mg nightly for 2 mounth
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
UrologyResearch Center
Full name of responsible person
Gholam Reza Pourmand MD.
Street address
Sina Hospital , Imam Khomeini st.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
UrologyResearch 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
Tehran University of Medical Science
Full name of responsible person
Mohammad Reza Nowroozi MD.
Position
Associated professor of urology
Other areas of specialty/work
Street address
Qods st , Keshavarz Blvd.
City
Tehran
Postal code
Phone
+98 21 6119 2764
Fax
Email
mrnowroozi@yahoo.com
Web page address
www.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Mohammad RezaNowroozi MD.
Position
Assosiated professor of urulogy
Other areas of specialty/work
Street address
Qods st. , Keshavarz Blvd.
City
Teran
Postal code
Phone
+98 21 6119 2764
Fax
Email
mrnowrooza@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Mohammad Reza Nowroozi MD
Position
Asssociated professor of urology
Other areas of specialty/work
Street address
Qods st. , Keshavarz Blvd.
City
Tehran
Postal code
Phone
+98 21 6119 2764
Fax
Email
Web page address
www.tums.ac.ir

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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