UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023497 |
|---|---|
| Receipt number | 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 | 2019/07/08 13:31:28 |
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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
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
yoshidtk@takii.kmu.ac.jp
Sponsor or person
Institute
Department of Urology and Andrology,
Kansai Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027067
