UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The impact of stent related pain and psychological well-being with stent strings extraction vs cystoscopy extraction on stent removal after ureteroscopy for urolithiasis: a clinical randomized trial
Title of the study (Brief title)	The impact of stent related pain and psychological well-being with stent strings extraction vs cystoscopy extraction on stent removal after ureteroscopy for urolithiasis: a clinical randomized trial
Region	Japan

Condition
Condition	Stone of upper urinary tract
Classification by specialty	Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Comparison with stent related pain on stent removal between 2 groups
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Comparison with stent related pain on stent removal between 2 groups
Key secondary outcomes	Comparison with psychological well-being on stent removal between 2 groups

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Using cystoscopy on stent removal
Interventions/Control_2	Using stent string on stent removal
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with indwelling ureteral stent after ureteroscopy for urolithiasis
Key exclusion criteria	Perfomance status >2 Patients treated bilateral upper tract stome at one stage procedure Patients emerges febrile urinary tract infection after procrdure Pregnancy Ballon mate or self catheterization Difficulty of communication
Target sample size	90

Research contact person
Name of lead principal investigator	Takaaki Inoue
Organization	Kansai Medical University, Takii Hospital
Division name	Urology and surgery
Address	10-15, Fumizono-tyou, Moriguchi-shi, Osaka, Japan
TEL	81-06-6992-1001
Email	inouetak@hirakata.kmu.ac.jp

Public contact
Name of contact person	Takaaki Inoue
Organization	Kansai Medical Universitym Takaii Hospital
Division name	Urology and Surgery
Address	10-15, Fumizono-tyou, Moriguchi-shi, Osaka, Japan
TEL	81-06-6992-1001
Homepage URL
Email	inouetak@hirakata.kmu.ac.jp

Sponsor
Institute	Kansai Medical Universitym Takaii Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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 06 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 12 Month 02 Day
Anticipated trial start date	2015 Year 01 Month 06 Day
Last follow-up date	2017 Year 01 Month 06 Day
Date of closure to data entry	2017 Year 01 Month 06 Day
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2014 Year 12 Month 05 Day
Last modified on	2018 Year 12 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018459