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Comparison of oral tamsulosin with oral tamsulosin and oral isosorbide dinitrate with in improvements trial without catheter (TWOC) for patients with acute urinary retention due to benign prostatic hyperplasia (BPH)

Protocol summary

Summary
This study is a clinical trial which performs in emergency department of Imam Khomeini hospital in Sari. All patients are under urinary catheter. After that they were explained about doing this research, written informed consent will be taken from them to enter into the study .and then, the samples are divided into two groups of 38 members. The first group received 0/4 mg of Tamsulosin Capsule from Modava daroo Company; it is given once a day at bed time. The second group received 0/4 mg of Tamsulosin hydrochloride along with Isosorbide dinitrate slow release by 20 mg every 12 hours and then the patient discharge from the Emergency department by doing urine and kidney function tests. After 72 hours of taking medication, the patients are reexamined again and their urinary catheter is removed, and the ability to urinate without a catheter is evaluated and weekly follow up will continue for a month and prostate volume verified by transrectal ultrasonography, and reuse of these patients to urinary catheter is checked. All patients 's information will be by the executive through track information which includes First and last name , Case number, Admission date , underlying disease , consumable drudges , Sonographic finding, Prostate volume, Urea, Creatine , Urine test, distended bladder, hypogasteric pain, urination feel, Age, the amount of urine discharged , will be gathered .

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017041724606N3
Registration date: 2017-05-10, 1396/02/20
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-05-10, 1396/02/20
Registrant information
Name
Hamed Aminiahidashti
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 1700
Email address
h.aminiahidashti@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for researche, Mazandaran University of Medical Siences
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2018-01-21, 1396/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of oral tamsulosin with oral tamsulosin and oral isosorbide dinitrate with in improvements trial without catheter (TWOC) for patients with acute urinary retention due to benign prostatic hyperplasia (BPH)
Public title
Comparison of oral tamsulosin with oral tamsulosin and oral isosorbide dinitrate with in improvements trial without catheter (TWOC) for patients with acute urinary retention due to benign prostatic hyperplasia (BPH)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with acute urinary retention caused by benign prostatic hypertrophy(BPH). Exclusion criteria: end stage renal disease; diabetes; history of urinary system surgery; malignancy; contraindication of tamsulusin and isosurbid consumption.
Age
From 40 years old
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 76
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Mazandaran University of Medical Sciences, Jooybar treeway, Imam Square
City
Sari
Postal code
4815724971
Approval date
2016-10-17, 1395/07/26
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.95.2440

Health conditions studied

1

Description of health condition studied
Acute urinary retention
ICD-10 code
R33
ICD-10 code description
Retention of urine

Primary outcomes

1

Description
Try of urination without a catheter(TWOC)
Timepoint
72 hours after intervention
Method of measurement
Observe of urination without a catheter(TWOC)

Secondary outcomes

1

Description
Vertigo
Timepoint
72 hours after intervention
Method of measurement
Observation

2

Description
Blood pressure
Timepoint
72 hours after intervention
Method of measurement
Sphygmomanometer(mmHg)

Intervention groups

1

Description
The control group tamsulosin capsules (0.4 mg) of the drug treatment is given once a day at bedtime in 3 days
Category
Treatment - Drugs

2

Description
Intervention group Tamsulosin hydrochloride capsules (0.4mg) of Medavadarv once a day at bedtime in 3 days, with slow-release tablets of ISO Surbid Di nitrite 20mg every 12 hours in 3 days
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Khomeni Hospital
Full name of responsible person
Hamed Aminiahidashti
Street address
Amir mazandarani Bolivard
City
Sari

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for researche, Mazandaran University of Medical Siences
Full name of responsible person
Ahmadali Enayati
Street address
Vice chancellor for researche, Mazandaran University of Medical Siences, Moallem Square
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for researche, Mazandaran University of Medical Siences
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
Mazandaran University of Medical Sciences
Full name of responsible person
Hamed Aminiahidashti
Position
Assistant Professor
Other areas of specialty/work
Street address
Emergency Department, Imam Khomeini Hospital, Amirmazandarani avenue
City
Sari
Postal code
4816633131
Phone
+98 11 3336 1700
Fax
Email
hamedaminiahidashti@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Hamed Aminiahidashti
Position
Assistant Professor
Other areas of specialty/work
Street address
Emergency Department, Imam Khomeini Hospital, Amirmazandarani avenue
City
Sari
Postal code
4816633131
Phone
+98 11 3336 1700
Fax
Email
hamedaminiahidashti@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Hamed Aminiahidashti
Position
Assistant Professor
Other areas of specialty/work
Street address
Emergency Department, Imam Khomeini Hospita, Amirmazandarani avenue
City
Sari
Postal code
4816633131
Phone
+98 11 3336 1700
Fax
Email
hamedaminiahidashti@yahoo.com
Web page address

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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