Survey The effect of Anticholinergic Drug On Uroflowmetri In Patient with Benign Prostatic Hyperplasia
Design
Clinical trial with out control
Settings and conduct
ََAdd toltrodine to standard medication in patient with benign prostatic hyperplasia with irritative symptoms refer to the urology clinic of Vasei Hospital during 1 month and do uroflowmetry and sonography before and after it.
Participants/Inclusion and exclusion criteria
All patients over the age of 50 with benign prostate enlargement who were treated with standard alpha-blockers and have irritable symptoms referred to the urology clinic of Vasei Hospital enrolled in the study.patient who had history of prostate or urinary tract surgery,history of prostate cancer,history of Neurological and spinal disease,history of use anticholinergic drug in 2 past weeks,have urinary residual over 250 cc disenrolled in study.
Intervention groups
Tolterodine 1 mg every 12 hours is added for one month to patients with benign prostate enlargement who have been pre-treated tamsulin 0/4 daily.tolterodine is anticholonergic drug.The drug work By blocking the muscarinic receptor.Side effects include dry mouth, drowsiness, urinary retention and constipation.chemical formula is C22H31NO.The brand name is Tolerin, manufactured by Tehran Drug Company
Main outcome variables
uroflowmetri ; prostate volume ; urine rezidual
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190928044913N1
Registration date:2019-11-11, 1398/08/20
Registration timing:retrospective
Last update:2019-11-11, 1398/08/20
Update count:0
Registration date
2019-11-11, 1398/08/20
Registrant information
Name
Amirhosein Zafaranian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3223 1465
Email address
zaferaniana91@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
2019-04-21, 1398/02/01
Actual recruitment end date
2019-06-24, 1398/04/03
Trial completion date
2019-06-24, 1398/04/03
Scientific title
Survey The Effect Of Anticholinergic Drug On Uroflowmetry In Patients With Benign Prostatic Hyperplasia
Public title
Effect of Anticholinergic Drug On uroflowmetry
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient Whit Benign Prostatic Hyperplasia treat with a Blaker
Exclusion criteria:
Past Mediacal History of Prostatic cancer
Age underb 50 years
Past Medical History Prostatic surgery
Past Medical History Of neurology illness
History Of Use Anticholinergic In 2 Past Week
Age
From 50 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Sabzevar University of Medical Sciences
Street address
sabzevar university of medical sciens, next to shohadaye gomnam,tohidshahr Blvd,
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Approval date
2016-08-31, 1395/06/10
Ethics committee reference number
IR.Medsab.rec.1395.41
Health conditions studied
1
Description of health condition studied
Benign Prostatic Hyperplasia
ICD-10 code
N40
ICD-10 code description
Enlarged prostate
Primary outcomes
1
Description
Q max in uroflowmetry
Timepoint
at begening and 1 month later
Method of measurement
uroflowmetri
Secondary outcomes
1
Description
urine rezidual
Timepoint
at beginnig and 1 month later
Method of measurement
sonography
2
Description
Prostate volume
Timepoint
at beginning and 1 month later
Method of measurement
sonography
Intervention groups
1
Description
Intervention group: Tolterodine 1 mg every 12 hours is added for one month to patients with benign prostate enlargement who have been pre-treated tamsulin 0/4 daily.tolterodine is anticholonergic drug.The drug work By blocking the muscarinic receptor.Side effects include dry mouth, drowsiness, urinary retention and constipation.chemical formula is C22H31NO.The brand name is Tolerin, manufactured by Tehran Drug Company.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
vasei hospital
Full name of responsible person
amirhosein zafaranian
Street address
Vasei Hospital , shohadaye hastei blvd
City
sabzevar
Province
Razavi Khorasan
Postal code
9617699117
Phone
+98 51 4401 1000
Email
zaferaniana91@medsab.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
fereshte ghorat
Street address
sabzevar university of medical sciens , next to shohadaye gomnam,shohadaye hastei Blvd
City
sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 1000
Fax
+98 51 4401 8484
Email
drghorat@gmail.com
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
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Amirhosein Zafaranian
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No 2 , taleghani ave , taleghani street , sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617699117
Phone
+98 11 3223 1465
Fax
Email
zaferanianA91@medsab.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Amirhosein Zafaranian
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No 2 , taleghani ave , taleghani street , sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617699117
Phone
+98 11 3223 1465
Fax
Email
zaferanianA91@medsab.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Amirhosein Zafaranian
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No 2 , taleghani ave , taleghani street , sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617699117
Phone
+98 11 3223 1465
Fax
Email
zaferanianA91@medsab.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available