The comparison of clinical manifestations of DJ adjustment in ureteral lumen with routine technique
Design
Two arm parallel randomized clinical trial, double blind in which the patients are divided in two group of 1 or 2 according to the number that will be picked up by patients and none of the patients and evaluator are not aware of allocation group.
Settings and conduct
In the Imam Reza Hospital of Kermanshah University of Medical Sciences during one year, 110 patients who require TUL and DJ insertion, will be allocated by a simple randomization in two groups of 1 and 2. In the group 1 following TUL the DJ will adjust routinely and in the group 2 the distal tail will be fixed in UVJ.
Participants/Inclusion and exclusion criteria
inclusion criteria:
1.The first time TUL
2.Age of 18-50 years
3. Ureter stone smaller than 15mm
4.No significant residual fragment in ureter (< 4 mm)
5.No bladder stone
6.Unilateral ureteral stone
7.No additional intervention be required following DJ insertion
8.Negative Urine Culture
9.IIEF-5> 21
Exclusion criteria:
1.History of urinary tract surgery
2.BPH
3.Long term LUTS
4.Coagulopathies
5.Anticoagulant drugs users
6.Advanced cardiac or hepatic disorders
7.Chronic consumption of NSAIDs or α-blockers
8.Pregnancy
9.IPSS > 7
Intervention groups
Intervention Group: following TUL, the distal tail of DJ adjusts in the ureter right in UVJ.
Control Group: following TUL, the distal tail of DJ adjusts in the bladder.
Main outcome variables
Urinary Symptom Score; Existence of Pain (%); Body Pain Score; VAS of Pain; General Health Score; Quality of Work Score; Quality of Sex Score; Quality of Life Score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180725040589N2
Registration date:2019-07-01, 1398/04/10
Registration timing:registered_while_recruiting
Last update:2019-07-01, 1398/04/10
Update count:0
Registration date
2019-07-01, 1398/04/10
Registrant information
Name
Mahmoudreza Moradi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3427 6337
Email address
drmoradi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-21, 1398/02/31
Expected recruitment end date
2020-05-20, 1399/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison of clinical manifestations of DJ adjustment in ureteral lumen with routine technique
Public title
the effect of route of ureteral stent adjustment and subsequent effects
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The first time TUL
Age of 18-50 years
Ureteral stone smaller than 15mm
No significant residual fragment in ureter (> 4 mm)
No bladder stone
Unilateral ureteral stone
No additional intervention be required following DJ insertion
Negative Urine Culture
IIEF-5> 21
Exclusion criteria:
History of urinary tract surgery
BPH
Long term LUTS
Coagulopathies
Anticoagulant drugs users
Advanced cardiac or hepatic disorders
Chronic consumption of NSAIDs or α-blockers
pregnancy
IPSS > 7
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
by picking up a piece of paper in a box by participant containing the same numbers of 1 (group one that distal tail of double J adjust routinely) and 1 (group 2 that distal tail of DJ is adjust in ureter in vesicoureteral junction)
Blinding (investigator's opinion)
Double blinded
Blinding description
None of patients and evaluator are aware of the groups
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kermanshah University of medical Sciences
Street address
Kermanshah, Shahid Beheshti Blvd. Central Building of University, Postal code: 6715847141
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2019-05-19, 1398/02/29
Ethics committee reference number
IR.KUMS.REC.1398.197
Health conditions studied
1
Description of health condition studied
Ureteral Stone
ICD-10 code
N13.2
ICD-10 code description
Hydronephrosis with renal and ureteral calculous obstruction
Primary outcomes
1
Description
Urinary Symptom Score
Timepoint
Before DJ insertion, first and forth weeks after DJ adjustment and a week after DJ removal
Method of measurement
By USSQ
2
Description
Existence of Pain (%)
Timepoint
Before DJ insertion, first and forth weeks after DJ adjustment and a week
Method of measurement
By USSQ
3
Description
Body Pain Score
Timepoint
Before DJ insertion, first and forth weeks after DJ adjustment and a week
Method of measurement
By USSQ
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: following TUL the distal tail of DJ adjusts in the ureter right in UVJ.
Category
Treatment - Surgery
2
Description
Control group:following TUL the distal tail of DJ adjusts in the bladder
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital of Kermanshah University of Medical Sciences
Full name of responsible person
Mahmoudreza Moradi
Street address
Kermanshah, Shahid Beheshti Blvd., Central Building of University
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3835 8258
Email
drmrmoradi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mahmoudreza Moradi
Street address
Kermanshah, Shahid Beheshti Blvd., Central Building of University
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3835 8258
Email
drmrmoradi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
5
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
Kermanshah University of Medical Sciences
Full name of responsible person
Mahmoudreza Moradi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Kermanshah, Shahid Beheshti Blvd., Central Building of University
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3835 8258
Email
drmrmoradi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mahmoudreza Moradi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Kermanshah, Shahid Beheshti Blvd., Central Building of University
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3835 8258
Email
drmrmoradi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mahmoudreza Moradi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Kermanshah, Shahid Beheshti Blvd., Central Building of University
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3835 8258
Email
drmrmoradi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is 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
Title and more details about the data/document
All the Gathered Data
When the data will become available and for how long
Following the end of study
To whom data/document is available
The Academic Resaerchers
Under which criteria data/document could be used
In order to promote our Knowledge
From where data/document is obtainable
By Mailing to corresponding Researcher
What processes are involved for a request to access data/document