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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000025437
Receipt No. 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 2016/12/27

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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
Email 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
Email ikedaj@hirakata.kmu.ac.jp

Sponsor
Institute Kansai Medical University, Medical Center
Institute
Department

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
Email

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 Preinitiation
Date of protocol fixation
2016 Year 10 Month 16 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 05 Day
Last follow-up date
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
2016 Year 12 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029279

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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