UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016214
Receipt No. R000018816
Scientific Title A Study of the optimal length of ureteral stent extraction string is not drawn into the urethra after transurethral ureterolithotomy
Date of disclosure of the study information 2015/01/15
Last modified on 2018/09/08

* 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 A Study of the optimal length of ureteral stent extraction string is not drawn into the urethra after transurethral ureterolithotomy
Acronym OLSES study
Scientific Title A Study of the optimal length of ureteral stent extraction string is not drawn into the urethra after transurethral ureterolithotomy
Scientific Title:Acronym OLSES study
Region
Japan

Condition
Condition Renal ureteral calculi
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 I study the optimal length of ureteral stent extraction string is not drawn into the urethra.
Basic objectives2 Others
Basic objectives -Others The optimal length of ureteral stent extraction string is not drawn into the urethra.
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Phase II

Assessment
Primary outcomes The optimal length of ureteral stent extraction string is not drawn into the urethra.
Key secondary outcomes Urination QOL
Complications

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Uncontrolled
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 I rermove ureteral stent using ureteral stent extraction string.
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
20 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria Patients who underwent TUL for renal and urinary tract stones.
Patients who can walk independence (Performance status: PS<=1).
Key exclusion criteria Communicate difficult cases.
If the doctor has determined ineligible during surgery.
PS>=2
The cases an attending physician determined ineligible.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takaaki Inoue
Organization Kansai Medical University Takii Hospital
Division name Urology
Zip code
Address Fumizonocho, 10-15, Moriguchi, Osaka
TEL 06-6992-1001(42206)
Email taguchim@takii.kmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takaaki Inoue
Organization Kansai Medical University Takii Hospital
Division name Urology
Zip code
Address Fumizonocho, 10-15, Moriguchi, Osaka
TEL 06-6992-1001(42206)
Homepage URL
Email taguchim@takii.kmu.ac.jp

Sponsor
Institute Kansai Medical University Takii Hospital Urology
Institute
Department

Funding Source
Organization Kansai Medical University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization None

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 関西医科大学附属滝井病院/ Kansai Medical University Takii Hospital

Other administrative information
Date of disclosure of the study information
2015 Year 01 Month 15 Day

Related information
URL releasing protocol
Publication of results Published

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
2015 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 01 Month 15 Day
Last follow-up date
2015 Year 04 Month 01 Day
Date of closure to data entry
2015 Year 04 Month 01 Day
Date trial data considered complete
2015 Year 04 Month 01 Day
Date analysis concluded
2015 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date
2015 Year 01 Month 14 Day
Last modified on
2018 Year 09 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018816

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.