Transurethral resection of prostate (TUR-P) is gold standard treatment of irritative and obstructive symptoms due to benign prostate hyperplasia (BPH). The most early complications after TUR-P (specially after catheter removal) are: urinary retention, and irritative symptoms such as frequency, dysuria, nucturia, and urgency that affects patients quality of life during the first weeks after TUR-P..In this trial we study the effects of toltrodin on patient's quality of life and early complications after TUR-P. This study is a double blind randomized placebo control clinical trials. Patients with indication of TUR-P surgery that hospitalized in Urmia imam Khomeini hospital during winter and spring 2012 are included. Exclusion criteria are: patients with urinary tract infection, bladder diverticule, neurologic or cardiovascular disease, hyperthyroidism, history of taking cholinergic or anti-cholinergic drugs, and post-voiding urinary residue more than 70ml. So 60 patients will randomized in treatment group (2mg toltrodine twice daily) and control group (placebo twice daily). After 1 month irritative lower urinary tract symptoms, pain (anti-analgesic usage) and patient's quality of life gather in two groups via questionnaire and conversation. Data will be analyzed by SPSS 17.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112255786N3
Registration date:2012-08-06, 1391/05/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-08-06, 1391/05/16
Registrant information
Name
Ali Tehranchi
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 1346 9931
Email address
tehranchi_a@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Urmia university of medical sciences
Expected recruitment start date
2012-03-10, 1390/12/20
Expected recruitment end date
2012-06-09, 1391/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of tolterodine on early irritative complication of lower urinary tract after transurethral resection of prostate
Public title
Effects of tolterodine on early irritative complication of lower urinary tract after transurethral resection of prostate
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: all patients that hospitalized for TURP in Feb to june in urmia imam khomeini hospital
Exclusion criteria: patients withbladder diverticula; neurologic disease; cardiovascular disease; hypo and hyperthyroidisim and patients with history of using cholinergic and antichonergic drugs, post-voding residue more than 70 ml
Age
From 50 years old to 85 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
6
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
Urmia university of medical sciences
Street address
Jahad street, urmia
City
Urmia
Postal code
Approval date
2011-12-19, 1390/09/28
Ethics committee reference number
4/2720 /پ
Health conditions studied
1
Description of health condition studied
Benign prostatic hyperplasia
ICD-10 code
D29.9
ICD-10 code description
N40
Primary outcomes
1
Description
Lower urinary tract symptoms
Timepoint
Before and one month after intervention
Method of measurement
Questionnaire
2
Description
analgesic nomber after surgery
Timepoint
1 month
Method of measurement
nomber of analgesic
3
Description
quality of life (IPSS)
Timepoint
1 month
Method of measurement
questionnaire
Secondary outcomes
1
Description
Urinary retension
Timepoint
1 month
Method of measurement
Questionnairy
Intervention groups
1
Description
tolteroadin 2mg ,oral tablet, 2 times daily
Category
Treatment - Drugs
2
Description
placebo, oral tablet, twice daily
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam khomeini hospital
Full name of responsible person
Ali tehranchi
Street address
Ershad street, Urmia
City
Urmia
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Urmia university of medical sciences
Full name of responsible person
Morteza Motezaker
Street address
Jahad street
City
Urmia
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Urmia 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
Urmia university of medical sciences
Full name of responsible person
Ali Tehranchi
Position
Scientific member
Other areas of specialty/work
Street address
Ershad st, Imam khomeini hospital
City
urmia
Postal code
Phone
+98 44 1346 9931
Fax
Email
tehranchi_a@umsu.ac.ir;Drtehranchi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Urmia university of medical sciences
Full name of responsible person
Ali Tehranchi
Position
Scientific member of urology department, urologist
Other areas of specialty/work
Street address
Ershad street, imam khomeini hospital
City
Urmia
Postal code
Phone
+98 44 1346 9931
Fax
Email
drtehranchi@yahoo.com tehranchi_a@umsu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Urmia university of medical sciences
Full name of responsible person
Reza Shojaie
Position
Urology resident
Other areas of specialty/work
Street address
Ershad stree, imam khomeini hospital
City
Urmia
Postal code
Phone
+98 44 1346 9931
Fax
Email
dr.reza-shojaie@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)