Today, ureteral stent is a necessary device to relieve upper urinary tract obstruction caused by a variety of etiologies. Symptoms of indwelling ureteral stent are potentially a health problem and have adverse effects on quality of life. The purpose of this clinical trial is to evaluate Tamsulosin and Tolterodine treatment effect on relieving indwelling ureteral stent symptoms. A group of 156 patients, who are going to undergo unilateral ureteral stenting for relieving upper urinary tract obstruction, will be selected based on inclusion and exclusion criteria. After stenting, they will be randomly assigned into three groups to receive four weeks medication with Tamsulosin 0.4mg at night or Tolterodine 2mg two times a day or placebo once per day. They will be prescribed Tramadol 50mg and Acetaminophen 500mg as analgesics -50 tablets of each one- to consume on demand. Patient's symptoms will be evaluated with the Ureteral Symptom Score Questionnaire (USSQ) one and four weeks after ureteral stenting. Their stent will be removed four weeks after insertion. They will be evaluated again with USSQ, one week after stent removal. Finally, amount of analgesic usage of each patient will be evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138812173509N1
Registration date:2010-05-09, 1389/02/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-05-09, 1389/02/19
Registrant information
Name
Sina Ebrahimi
Name of organization / entity
Kermanshah University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 61 1336 6523
Email address
sebrahimi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for research, Kermanshah University of Medical Sciences and Health Services
Expected recruitment start date
2010-03-07, 1388/12/16
Expected recruitment end date
2010-10-08, 1389/07/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of Tolterodine, Tamsulosin, and placebo effects on symptoms of indwelling ureteral stent
Public title
Effective treatment to relieve indwelling ureteral stent symptoms
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Ureteral stenting for treatment of ureteral obstruction due to upper tract urinary stone (kidney or ureter)
Exclusion criteria: history of urinary system surgery, BPH (IPSS>7), long standing lower urinary tract symptoms, Indwelling ureteral stent at presentation, treatment with NSAIDs or Alpha-blockers, advanced cardiac or hepatic disease, Pregnancy
Age
From 16 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
156
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
Kermanshah University of Medical Sciences and Health Servises Ethical Committee
Street address
No.2 building, Kermanshah University of medical sciences, Shahid Beheshti Blvd, Kermanshah
City
Kermanshah
Postal code
Approval date
2010-02-27, 1388/12/08
Ethics committee reference number
54122
Health conditions studied
1
Description of health condition studied
Symptoms of indwelling ureteral stent
ICD-10 code
T83.5 , T8
ICD-10 code description
Infection and inflammatory reaction due to prosthetic device, implant and graft in urinary system - Unspecified complication of genitourinary prosthetic device, implant and graft
Primary outcomes
1
Description
Relieving of indwelling ureteral stent symptoms
Timepoint
1 week and 4 weeks after insertion, 1 week after removal
Method of measurement
Ureteral stent symptom score questionnaire (USSQ)
Secondary outcomes
1
Description
Presence of indwelling ureteral stent symptoms in spite of medication
Timepoint
1 week and 4 weeks after insertion, 1 week after removal
Method of measurement
Ureteral stent symptom score questionnaire (USSQ)
Intervention groups
1
Description
Tamsulosin 0.4mg capsule at bedtime for 4 weeks
Category
Treatment - Drugs
2
Description
Tolterodine 2mg tablet two times a day (morning , evening) for 4 weeks