UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041095
Receipt number R000046933
Scientific Title Examination of the recurrence rate in the treatment of urolithiasis in patients taking beta-adrenergic receptor agonists
Date of disclosure of the study information 2020/07/13
Last modified on 2020/07/14 19:11:20

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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 or person

Institute

Showa University Fujigaoka Hospital

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046933


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name