UMIN-CTR Clinical Trial

Basic information
Public title	Examination of the recurrence rate in the treatment of urolithiasis in patients taking beta-adrenergic receptor agonists
Acronym	Examination of the recurrence rate in the treatment of urolithiasis in patients taking beta-adrenergic receptor agonists
Scientific Title	Examination of the recurrence rate in the treatment of urolithiasis in patients taking beta-adrenergic receptor agonists
Scientific Title:Acronym	Relationship between beta-adrenergic receptor agonists and ureteral stones
Region	Japan

Condition
Condition	Ureteral stones
Classification by specialty	Surgery in general Urology Emergency medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the clinical effects of beta-adrenergic receptor agonists on the treatment of ureteral stones
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Complete fracture rate of ureteral stones, postoperative recurrence rate, HU value
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	10 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	All patients treated with ureteral stones at Showa University Fujigaoka Hospital
Key exclusion criteria	(1) Patients under 10 years old (2) Patients who do not get written consent (3) Patients who cannot be examined by CT (4) Patients scheduled to be treated in another hospital (5) Patients who are judged to be inappropriate by other researchers
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Yuki Middle name Last name Matusi
Organization	Showa University Fujigaoka Hospital
Division name	Urology Department
Zip code	227-8501
Address	1-30 Fujigaoka Aoba-ku Yokohama Kanagawa Japan
TEL	045-971-1151
Email	hyperzector555@med.showa-u.ac.jp

Public contact
Name of contact person	1st name Yuki Middle name Last name Matsui
Organization	Showa University Fujigaoka Hospital
Division name	Urology Department
Zip code	227-8501
Address	1-30 Fujigaoka Aoba-ku Yokohama Kanagawa Japan
TEL	045-971-1151
Homepage URL
Email	hyperzector555@med.showa-u.ac.jp

Sponsor
Institute	Showa University Fujigaoka Hospital
Institute
Department

Funding Source
Organization	Showa University Fujigaoka Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Showa University Fujigaoka Hospital Clinical Study Review Board
Address	1-30 Fujigaoka Aoba-ku Yokohama Kanagawa Japan
Tel	045-971-1151
Email	hyperzector555@med.showa-u.ac.jp

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

Other administrative information
Date of disclosure of the study information	2020 Year 07 Month 13 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	Open public recruiting
Date of protocol fixation	2019 Year 12 Month 01 Day
Date of IRB	2019 Year 12 Month 18 Day
Anticipated trial start date	2019 Year 12 Month 19 Day
Last follow-up date	2026 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Regarding the treatment of ureteral stones at Showa University Fujigaoka Hospital, we will investigate the effect of beta-adrenergic receptor stimulants and perform statistical analysis.

Management information
Registered date	2020 Year 07 Month 13 Day
Last modified on	2020 Year 07 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046933