UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025437 |
|---|---|
| Receipt number | R000029279 |
| Scientific Title | The impact of hydronephrosis improvement after ureteroscopy for ureteral stone with edema using Saireito |
| Date of disclosure of the study information | 2017/01/05 |
| Last modified on | 2021/10/26 22:40:23 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The impact of hydronephrosis improvement after ureteroscopy for ureteral stone with edema using Saireito
Acronym
The impact of hydronephrosis improvement after ureteroscopy for ureteral stone with edema using Saireito
Scientific Title
The impact of hydronephrosis improvement after ureteroscopy for ureteral stone with edema using Saireito
Scientific Title:Acronym
The impact of hydronephrosis improvement after ureteroscopy for ureteral stone with edema using Saireito
Region
| Japan |
Condition
Condition
Ureteral stone
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Impacted stone almost has hydronephrosis preoperatively because of obstruction due to ureteral stones.Certainly, it takes a little time before the ureteral edema on stone interstitial segment has been improved.Saireito had been already used for management of edema.The effect for ureteral edema is not known yet.
This study was performed to investigate the impact of hydronephrosis improvement after ureteroscopy for ureteral stone with edema using Saireito.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison with the ratio of the area in hydronephrosis to the area of kidney in the largest cross-sectional slice using ultrasonography between two groups.
Key secondary outcomes
1)Comparison with stent related pain on stent removal between two groups
2)Comparison with grade of hydronephrosis between two groups
3)Comparison with psychological well-being on stent removal between two groups
4)Comparison with OABSS(Overactive bladder symptom score) and IPSS(International Prostate Symptom Score)on stent removal between two groups
5)Comparison with quantity and frequency of analgestic drug on stent removal between two groups
6)Comparison with complication between two groups
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Take Saireito orally
Interventions/Control_2
Not to be taken internally
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with ureteral stone and hydronephrosis before transurethral ureterolithotripsy (TUL)
Key exclusion criteria
1)Patients treated bilateral upper tract stone at one stage procedure
2)Patients with thinning of the kidney
3)Patients emerges febrile urinary tract infection after procedure
4)Difficulty of communication
5)When doctor had judged the patients need stent for a long time
6)When doctor had judged the patients disqualified as a subject of this study
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junichi Ikeda |
Organization
Kansai Medical University, Medical Center
Division name
Urology
Zip code
Address
10-15, Fumizono-cho, Moriguchi, Osaka, Japan
TEL
81-6-6992-1001
ikedaj@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junichi Ikeda |
Organization
Kansai Medical University, Medical Center
Division name
Urology
Zip code
Address
10-15, Fumizono-cho, Moriguchi, Osaka, Japan
TEL
81-6-6992-1001
Homepage URL
ikedaj@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University, Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
関西医科大学総合医療センター/Kansai Medical University, Medical Center
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
| 2016 | Year | 10 | Month | 16 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 07 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 27 | Day |
Last modified on
| 2021 | Year | 10 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029279
