UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015863 |
|---|---|
| Receipt number | R000018459 |
| Scientific Title | The impact of stent related pain and psychological well-being with stent strings extraction vs cystoscopy extraction on stent removal after ureteroscopy for urolithiasis: a clinical randomized trial |
| Date of disclosure of the study information | 2015/01/06 |
| Last modified on | 2018/12/07 10:26:13 |
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Basic information
Public title
The impact of stent related pain and psychological well-being with stent strings extraction vs cystoscopy extraction on stent removal after ureteroscopy for urolithiasis: a clinical randomized trial
Acronym
The impact of stent related pain and psychological well-being with stent strings extraction vs cystoscopy extraction on stent removal after ureteroscopy for urolithiasis: a clinical randomized trial
Scientific Title
The impact of stent related pain and psychological well-being with stent strings extraction vs cystoscopy extraction on stent removal after ureteroscopy for urolithiasis: a clinical randomized trial
Scientific Title:Acronym
The impact of stent related pain and psychological well-being with stent strings extraction vs cystoscopy extraction on stent removal after ureteroscopy for urolithiasis: a clinical randomized trial
Region
| Japan |
Condition
Condition
Stone of upper urinary tract
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison with stent related pain on stent removal between 2 groups
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison with stent related pain on stent removal between 2 groups
Key secondary outcomes
Comparison with psychological well-being on stent removal between 2 groups
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Using cystoscopy on stent removal
Interventions/Control_2
Using stent string on stent removal
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with indwelling ureteral stent after ureteroscopy for urolithiasis
Key exclusion criteria
Perfomance status >2
Patients treated bilateral upper tract stome at one stage procedure
Patients emerges febrile urinary tract infection after procrdure
Pregnancy
Ballon mate or self catheterization
Difficulty of communication
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takaaki Inoue |
Organization
Kansai Medical University, Takii Hospital
Division name
Urology and surgery
Zip code
Address
10-15, Fumizono-tyou, Moriguchi-shi, Osaka, Japan
TEL
81-06-6992-1001
inouetak@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takaaki Inoue |
Organization
Kansai Medical Universitym Takaii Hospital
Division name
Urology and Surgery
Zip code
Address
10-15, Fumizono-tyou, Moriguchi-shi, Osaka, Japan
TEL
81-06-6992-1001
Homepage URL
inouetak@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical Universitym Takaii Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
関西医科大学附属滝井病院/Kansai Medical University Takii Hospital
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 12 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2017 | Year | 01 | Month | 06 | Day |
Date of closure to data entry
| 2017 | Year | 01 | Month | 06 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 05 | Day |
Last modified on
| 2018 | Year | 12 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018459
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
