The aim of this study was to evaluate the effects of adding tadalafil to tamsulosin for the treatment of acute urinary retention in patients with benign prostatic hyperplasia. A double-blind randomized clinical trial Patients in the study, 80 patients with acute urinary retention in an emergency.
After draining urine with nelaton,accidentally, Tadalafil 10 mg with a 0.4 mg Tamsulosin capsule or Tamsulosin with placebo for seven days is given.Then 24 hours and a week later with a phone call from the patient's urinary retention, he asked again.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017041833506N1
Registration date:2017-09-13, 1396/06/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-09-13, 1396/06/22
Registrant information
Name
zeinab ameli
Name of organization / entity
sabzevar university of medical scinence
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 6778
Email address
ameliz88@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Sabzevar University of Medical Sciences
Expected recruitment start date
2016-09-23, 1395/07/02
Expected recruitment end date
2017-04-21, 1396/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey the addition of tadalafil to tamsulosin in the treatment of acute urinary retention in patient with benign prostatic hyperplasia
Public title
Evaluation of the effect of tadalafil on the treatment of acute urinary retention
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients who refused to participate in the study and signed informed consent form; Age over 50 years;Symptoms of LUTS or urinary tract symptoms.Exclusion criteria: Discontent of continued cooperation with the study for any reason and at any stage of the research; Age less than 50 years; Proven history of prostate cancer; Prostatitis; Urethral obstruction caused by tumor; known tumor disease caused by lower urinary tract (bladder stones, neurogenic bladder, bladder cancer, urethral stricture); Surgery lower urinary tract (bladder, prostate and urethra); Nitrate consumption at the same time; Acute urinary retention after surgery
Age
From 45 years old to 6 years old
Gender
Male
Phase
2-3
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
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Sabzevar University of Medical Sciences
Street address
Tohid Town, Medical Science Paradise
City
Sabzevar
Postal code
Approval date
2016-09-22, 1395/07/01
Ethics committee reference number
IR.MEDSAB.REC.1395.96
Health conditions studied
1
Description of health condition studied
acute urinary retention
ICD-10 code
N40
ICD-10 code description
Hyperplasia of prostate
Primary outcomes
1
Description
Acute Urinary Retention
Timepoint
24 hours and one week after the intervention.
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, 10 mg Tadalafil tablets plus 0.4 mg Tamsulosin capsule once a day for seven days
Category
Treatment - Drugs
2
Description
Placebo pills (in the same way, the size and color of tadalafil made from starch) with Tamsulosin capsules 0.4 milligrams per night for one week
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Vasei Hospital of Sabzevar
Full name of responsible person
Zeinab Ameli
Street address
Vasei Hospital of Sabzevar
City
Sabzevar
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Hamidreza Baghani Aval
Street address
Sabzevar, Medical Science Pardis
City
Sabzevar
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Zeinab Ameli
Position
General Practitioner
Other areas of specialty/work
Street address
Sabzevar University of Medical Sciences
City
Sabzevar
Postal code
Phone
+98 51 3859 6778
Fax
Email
zameli_2010@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Science
Full name of responsible person
Hamidreza Baghani Aval
Position
Assistant Professor
Other areas of specialty/work
Street address
Sabzevar University of Medical Science
City
Sabzevar
Postal code
Phone
+98 51 4444 6070
Fax
Email
hamidreza_baghani@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Science
Full name of responsible person
Zeinab Ameli
Position
General Practitioner
Other areas of specialty/work
Street address
Sabzevar University of Medical Sciences
City
Sabzevar
Postal code
Phone
+98 51 3859 6778
Fax
Email
zameli_2010@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)