UMIN-CTR Clinical Trial

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