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Comparison of the effect of Terazosin, Tolterodine, and their combination in the treatment of double J stent-related urinary symptoms in patients with ureteral stones

Protocol summary

Study aim
to evaluate the effect of Terazocine, Tolterodine and their combination in the treatment of double J stent-related urinary tract symptoms in patients with ureteral stones
Design
A phase 3, single-blinded, sham-controlled randomized clinical trial (RCT) with the parallel-groups design of 80 patients. Simple individual randomization was done using sealed envelopes.
Settings and conduct
The study was performed in the Ghaem hospital, Mashhad, Iran. It was a single-blind RCT in which the research participants were blinded to the randomization. Each group of patients received the allocated medication following transurethral lithotripsy and double J stent placement. The Ureteral Stent Symptoms Questionnaire (USSQ) questionnaire was used to evaluate the double J stent-related urinary tract symptoms after 2 weeks of stent placement.
Participants/Inclusion and exclusion criteria
inclusion criteria: patients with ureteral stones undergoing transurethral lithotripsy exclusion criteria: History of major urinary surgery; Benign prostate hyperplasia under medical therapy; Overactive bladder; Drug sensitivity
Intervention groups
patients are randomized into 4 groups receiving the following medications respectively: Terazosin 2 mg twice a day, Tolterodine 2 mg twice a day, Terazocine+Tolterodine with the same dosage, and placebo
Main outcome variables
double J stent-related lower urinary tract symptoms

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160924029935N2
Registration date: 2020-05-26, 1399/03/06
Registration timing: retrospective

Last update: 2020-05-26, 1399/03/06
Update count: 0
Registration date
2020-05-26, 1399/03/06
Registrant information
Name
Seyedalireza Ghoreifinejadian
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3858 3885
Email address
ghoreifina@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-20, 1397/12/29
Expected recruitment end date
2020-03-18, 1398/12/28
Actual recruitment start date
2019-03-20, 1397/12/29
Actual recruitment end date
2020-03-18, 1398/12/28
Trial completion date
2020-03-18, 1398/12/28
Scientific title
Comparison of the effect of Terazosin, Tolterodine, and their combination in the treatment of double J stent-related urinary symptoms in patients with ureteral stones
Public title
The effect of Terazosin and Tolterodine in the treatment of double J stent-related urinary symptoms
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with ureteral stones undergoing unilateral transurethral lithotripsy
Exclusion criteria:
History of major urinary surgery Benign prostate hyperplasia under medical therapy Overactive bladder Drug sensitivity
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 80
More than 1 sample in each individual
Number of samples in each individual: 20
4 groups: 20 patients in each group
Actual sample size reached: 20
Randomization (investigator's opinion)
Randomized
Randomization description
simple individual randomization using sealed envelopes
Blinding (investigator's opinion)
Single blinded
Blinding description
Research participants were blinded to the randomization. To maintain blindness, identical-looking medications and placebo without any label were used.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Ghoreishi Building, Daneshgah St
City
Mashhad
Province
Razavi Khorasan
Postal code
91357345
Approval date
2018-12-17, 1397/09/26
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1397.603

Health conditions studied

1

Description of health condition studied
lower urinary tract symptoms, ureteral stone
ICD-10 code
N20.9
ICD-10 code description
Urinary calculus, unspecified

Primary outcomes

1

Description
ureteral stent urinary symptoms
Timepoint
2 weeks after intervention
Method of measurement
Ureteral Stent Symptoms Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 1; Tab Terazosin 2 mg BID for 2 weeks
Category
Treatment - Drugs

2

Description
Intervention group: 2; Tab Tolterodine 2 mg BID for 2 weeks
Category
Treatment - Drugs

3

Description
Intervention group: 3, Tab including Terazosin 2 mg+Tolterodine 2mg, BID for 2 weeks
Category
Treatment - Drugs

4

Description
Control group: Tab Placebo (identical-looking with the medication) BID 2 for weeks
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Alireza Akhavan Rezayat
Street address
Ahmadabad St
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3840 0001
Email
b.ghaem@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Daneshgah St
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Alireza Akhavan Rezayat
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Urology Department, Ghaem Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3840 0001
Fax
Email
akhavanra@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Alireza Akhavan Rezayat
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Urology Department, Ghaem Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3840 0001
Fax
Email
akhavanra@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyedalireza Ghoreifinejadian
Position
Assistant Professor of Urology
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Urology Departmrnt, Imam Reza Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 38050
Fax
Email
aghoreifi@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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