Ureteral stent (US) has been as essential tool in the urologist’s surgeries and is useful instruments that its indications increase due to new stent technologies and improvement of patient’s comfort.
US associated with discomfort complications that include lower urinary tract symptoms (LUTS) as frequency, urgency, dysuria, incomplete emptying, flanks and suprapubic’s pain, incontinence, hematuria, movement of stent, infection and encrustation of stent. US related symptoms are as same as LUTS due to benign prostate hyperplasia and overactive bladder which relieve with alpha-blockers and anticholinergic. The purpose of our study is to investigate the effect of terazosin( alfa blocker) and tolterodine(anticholinergic) lonely and together in comparison of placebo on US related symptoms.
Our study will be done prospectively. The patients who underwent indwelling double-j stent distributed into four groups: 1)receive placebo 2)receive terazosin 2mg twice 3)receive tolterodine 2mg daily 4) receive terazosin 2mg twice and tolterodine 2mg daily. All of the patients receive prophylactic antibiotic and on demand analgesic. The patients will be used drugs from US indwelling to US removal time. After entrance to study, they fulfill the IPSS and VAS on the before indwelling US, two weeks after indwelling US and US removal time, then the investigators will evaluate the drug’s effect on US related symptoms.
General information
Acronym
US= Ureteral stent
IPSS= International Prostate Symptom Score
LUTS= lower urinary tract symptom
V
IRCT registration information
IRCT registration number:IRCT201111255786N2
Registration date:2012-03-04, 1390/12/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-03-04, 1390/12/14
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
2011-12-31, 1390/10/10
Expected recruitment end date
2012-12-27, 1391/10/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of terazosin and tolterodine on ureterl stent related symptoms
Public title
The effect of terazosin and tolterodine on ureterl stent related symptoms
Purpose
Treatment
Inclusion/Exclusion criteria
Exclusion criteria:
1) Prior history of pelvic surgery
2) Prior history of Transurethral Resection of the either Prostate or Bladder Tumor
3) Benign prostate hyperplasia
4) Recent or recurrent urinary tract infection
5) Chronic medication with -blockers or Anti-cholinergic
6) Pregnancy
7) Prostatitis
8) Prostate cancer
9) Bilateral ureteroscopy or ureteral stenting
10) Age >18 and <55
11) Stone size >20 mm
12) Diabetes
13) Bladder Outlet Obstruction
Inclusion criteria:
If a patient dose not meet any exclusion criteria and to be undergone double-J stent indwelling.
Age
From 18 years old to 55 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
clinicaltrial.gov
Secondary trial Id
UUNRC 01
Registration date
2012-01-18, 1390/10/28
Ethics committees
1
Ethics committee
Name of ethics committee
Local ethic's committee of Urmia University of Medical Sciences
Street address
Urmia University of Medical Sciences, Resalat Blvd, Urmia,Iran
City
Urmia
Postal code
Approval date
2011-12-03, 1390/09/12
Ethics committee reference number
p/4/2608
Health conditions studied
1
Description of health condition studied
Ureteral stent (Double-J stent) related symptoms
ICD-10 code
N20, N20.1
ICD-10 code description
Calculus of kidney, Calculus of ureter, Calculus of kidney with calculus of ureter, Hydronephrosis with ureteropelvic junction obstruction
Primary outcomes
1
Description
Lower Urinary Tract Symptoms
Timepoint
before intervention, 14days after intervention, stent removal time
Method of measurement
IPSS(International Prostate Symptom Score) and VAS(Visual Analogue Scale)
Secondary outcomes
1
Description
Drug complications
Timepoint
Stent removal time
Method of measurement
Getting history from patient
2
Description
Amount of analgesic consumption
Timepoint
Stent removal time
Method of measurement
Getting history from patient
Intervention groups
1
Description
Group1: Placebo
same as tolterodine and terazosin dose
Category
Placebo
2
Description
Group2: Terazosin 2mg BID
Category
Treatment - Drugs
3
Description
Group3: Tolterodine 2mg Daily
Category
Treatment - Drugs
4
Description
Group4: Tolterodine 2mg Daily + Terazosin 2mg BID
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam khomeini hospital
Full name of responsible person
Urology & Nephrology Research Center
Street address
City
Urmia
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vicechancellor for research, Urmia University of Medical Sciences
Full name of responsible person
morteza motezaker
Street address
Urmia University of Medical Sciences, Resalat Blvd, Urmia,Iran
City
Urmia
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vicechancellor for research, 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
Faculty of medicine, Urmia University of Medical Sciences
Full name of responsible person
Yousef Rezaei
Position
Student of medicine
Other areas of specialty/work
Street address
Urmia University of Medicam Sciences, Urmia, Iran
City
Urmia
Postal code
Phone
+98 44 1223 4897
Fax
Email
yousefrezaei1986@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Urology and Nephrology Research Center, Department of Urology
Full name of responsible person
Ali Tehranchi
Position
Urologist
Other areas of specialty/work
Street address
Imam khomeini hospital, Ershad Blvd, Urmia,Iran
City
Urmia
Postal code
Phone
+98 44 1345 9542
Fax
Email
drtehranchi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of medicine, Urmia University of Medical Sciences
Full name of responsible person
Yousef Rezaei
Position
Student of medicine
Other areas of specialty/work
Street address
Urmia University of Medicam Sciences, Urmia, Iran
City
Urmia
Postal code
Phone
+98 44 1223 4897
Fax
Email
yousefrezaei1986@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)