UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034067 |
|---|---|
| Receipt number | R000038819 |
| Scientific Title | A prospective randomized controlled trial comparing a ureteral stent crossing versus not crossing the bladder midline |
| Date of disclosure of the study information | 2018/10/01 |
| Last modified on | 2021/11/29 16:37:31 |
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Basic information
Public title
A prospective randomized controlled trial comparing a ureteral stent crossing versus not crossing the bladder midline
Acronym
NOTCROSS trial
Scientific Title
A prospective randomized controlled trial comparing a ureteral stent crossing versus not crossing the bladder midline
Scientific Title:Acronym
NOTCROSS trial
Region
| Japan |
Condition
Condition
Ureteric and renal stones
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prospectively compare the influence of ureteral stent position in the bladder on urinary symptoms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Difference in the change in the total points of IPSS and OABSS before and after ureteral stent placement between two groups.
Key secondary outcomes
1. Difference in change amount of each item of IPSS
2. Difference in change amount of each item of OABSS
3. Can it be a useful indicator when choosing a ureteral stent whose height is appropriate?
4. Difference in pain due to ureteral stent during ureteral stent placement
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
A group that ureteral stent tail is left inside the bladder without crossing the midline.
Interventions/Control_2
A group that ureteral stent tail is left inside the bladder crossing the midline.
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, Over 20 years old
2. Patients who can describe the questionnaire
3. Patients who can understand this study
4, patients undergoing TUL for upper urinary calculi
Key exclusion criteria
1) Active urinary tract infection
2) Concomitant medication with alpha blockers, antimuscarinics, analgesics, beta-3 agonist, PDE 5 inhibitor
3) Pregnancy
8) Ureteral stent placement before TUL
9) Bilateral ureteral stenting
10) Bladder cancer
11) Prostate cancer
12) Neurogenic bladder
13) Chronic prostatitis
14) Complications during ureteroscopy such as ureteral perforation
15) Lower ureteral calculi
Target sample size
128
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Taguchi |
Organization
Osaka Saiseikai Izuo Hospital
Division name
Department of Urology
Zip code
551-0032
Address
3-4-5, Kitamura, Taisho-ku, Osaka
TEL
06-6552-0091
taguchim@takii.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Taguchi |
Organization
Osaka Saiseikai Izuo Hospital
Division name
Department of Urology
Zip code
551-0032
Address
3-4-5, Kitamura, Taisho-ku, Osaka
TEL
06-6552-0091
Homepage URL
taguchim@takii.kmu.ac.jp
Sponsor or person
Institute
Osaka Saiseikai Izuo Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Saiseikai Izuo Hospital
Address
3-4-5, Kitamura, Taisho-ku, Osaka
Tel
06-6552-0091
taguchim@takii.kmu.ac.jp
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
| 2018 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
113
Results
Comparing changes from baseline IPSS and OABSS scores between the two groups, the crossing midline group had a worse OABSS total score than the not crossing group (3.0 +- 2.8 vs 2.0 +- 3.3, respectively; p = 0.032). There was no significant difference between the crossing vs not crossing groups in the IPSS total score (6.8 +- 7.6 vs 5.1 +- 8.5, respectively; p = 0.14).
Results date posted
| 2021 | Year | 11 | Month | 29 | Day |
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
| 2018 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 24 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 09 | Month | 08 | Day |
Last modified on
| 2021 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038819
