UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of intra-ureteral placement versus conventional placement, with loop-tail ureteral stent, for stent-related quality of life and complications after ureteroscopic lithotripsy: a prospective randomized control trial
Acronym	Comparison of intra-ureteral placement versus conventional placement, with loop-tail ureteral stent, for stent-related quality of life and complications after ureteroscopic lithotripsy: a prospective randomized control trial
Scientific Title	Comparison of intra-ureteral placement versus conventional placement, with loop-tail ureteral stent, for stent-related quality of life and complications after ureteroscopic lithotripsy: a prospective randomized control trial
Scientific Title:Acronym	Comparison of intra-ureteral placement versus conventional placement, with loop-tail ureteral stent, for stent-related quality of life and complications after ureteroscopic lithotripsy: a prospective randomized control trial
Region	Japan

Condition
Condition	Urolithiasis
Classification by specialty	Urology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine whether intra-ureteral stent placement improves stent-related quality of life and complications, compared with conventional stent placement, using loop-tail ureteral stent, after ureteroscopy for stone disease.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	Change from baseline to each point in mean total score of Visual analog scale
Key secondary outcomes	Change from baseline to each point in mean sub-score of IPSS, OABSS, Visual analog scale, and SF36v2 Change from baseline to each point in mean total of SF-36v2 and IPSS and OABSS. Safety assessment Presence of hydronephrosis confirmed by ultrasonography after urethral catheter removal Migration of tip of suture (intra-ureteral placement group) or tip of stent (conventional placement group) into the ureter Presence of febrile urinary tract infection after urethral catheter removal Early spontaneous stent removal Retained stent Other stent-related symptoms

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Stent implantation with conventional technique
Interventions/Control_2	Stent implantation with intra-ureteral placement technique
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Patients undergoing transurethral lithotripsy (TUL) for renal and/or ureteral stone 2.Patients with informed consent
Key exclusion criteria	1.Patients with lower ureteral stone (U3) 2.Patients who had pre-stenying 3.Patients potentially requiring a ureteric stent for >14days postoperatively 4.Patients undergoing bilateral TUL 5.Patients with solitary kidney 6.Patients with difficulty of communication 7.Pregnant 8.patients who have been determined to be unsuitable as a subject by a physician
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takashi Yoshida
Organization	Kori hospital, Kansai medical university
Division name	Department of Urology and Andrology
Zip code
Address	Kori hondori-cyou 8-45, Neyagawa, Osaka 572-8551, Japan
TEL	0728329500
Email	yoshidtk@takii.kmu.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Takashi Yoshida
Organization	Kansai Medical University, kori hospital
Division name	Department of Urology and Andrology
Zip code
Address	Kori hondori-cyou 8-45, Neyagawa, Osaka 572-8551, Japan
TEL	0728329500
Homepage URL
Email	yoshidtk@takii.kmu.ac.jp

Sponsor
Institute	Department of Urology and Andrology, Kansai Medical University
Institute
Department

Funding Source
Organization	Department of Urology and Andrology, Kansai medical university
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2016 Year 08 Month 05 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	Completed
Date of protocol fixation	2016 Year 05 Month 31 Day
Date of IRB	2016 Year 08 Month 01 Day
Anticipated trial start date	2016 Year 08 Month 05 Day
Last follow-up date	2017 Year 09 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 08 Month 04 Day
Last modified on	2019 Year 07 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027067