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Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023497
Receipt No. R000027067
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
Date of disclosure of the study information 2016/08/05
Last modified on 2018/03/10

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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 No longer recruiting
Date of protocol fixation
2016 Year 05 Month 31 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 05 Day
Last follow-up date
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
2018 Year 03 Month 10 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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