UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Study of the optimal length of ureteral stent extraction string is not drawn into the urethra after transurethral ureterolithotomy
Title of the study (Brief title)	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	Takaaki Inoue
Organization	Kansai Medical University Takii Hospital
Division name	Urology
Address	Fumizonocho, 10-15, Moriguchi, Osaka
TEL	06-6992-1001(42206)
Email	taguchim@takii.kmu.ac.jp

Public contact
Name of contact person	Takaaki Inoue
Organization	Kansai Medical University Takii Hospital
Division name	Urology
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

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 01 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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