UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019765 |
|---|---|
| Receipt number | R000022825 |
| Scientific Title | Development of new device for BCR monitoring using transurethral stimulation under general aneasthesia. |
| Date of disclosure of the study information | 2015/11/12 |
| Last modified on | 2021/12/03 16:07:46 |
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Basic information
Public title
Development of new device for BCR monitoring using transurethral stimulation under general aneasthesia.
Acronym
BTUS study
Scientific Title
Development of new device for BCR monitoring using transurethral stimulation under general aneasthesia.
Scientific Title:Acronym
BTUS study
Region
| Japan |
Condition
Condition
Spinal and spinal cord surgery in lumber level
Classification by specialty
| Orthopedics | Urology | Anesthesiology |
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Development of new device for bulbocavernosus reflex monitoring using transurethral stimulation under general anaesthesia to record successfully with high reliability.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Success rate for recording control waveform of BCR monitoring
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Insertion of stimulation catheter into urethra
Interventions/Control_2
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
| 100 | years-old | >= |
Gender
Female
Key inclusion criteria
Spinal and spinal cord surgery in lumbar level
Key exclusion criteria
Urethral disease
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takeaki |
| Middle name | |
| Last name | Shinjo |
Organization
Nara Medical University
Division name
Anaesthesiolosy
Zip code
6348522
Address
840, Sijo, Kasihara, Nara, Japan
TEL
0742466001
tshinjo@hotmail.co.jp
Public contact
Name of contact person
| 1st name | Takeaki |
| Middle name | |
| Last name | Shinjo |
Organization
Nara Medical University
Division name
Anaesthesiolosy
Zip code
6348522
Address
840, Sijo, Kasihara, Nara, Japan
TEL
0744-22-3051
Homepage URL
tshinjo@hotmail.co.jp
Sponsor or person
Institute
Depertment of Anaesthesiolosy, Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Depertment of Anaesthesiolosy, Nara Medical University
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
Nara Medical University Ethics Committee
Address
840, Sijo, Kasihara, Nara, Japan
Tel
0744-22-3051
irb-rinri@naramed-u.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
| 2015 | Year | 11 | Month | 12 | 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
16
Results
Success rate of baseline BCR recording
Conventional BCR (c-BCR) was 68.8%(11/16), and trans-urethral BCR (tu-BCR) was 87.5% (14/16)
There were no significant differences in amplitudes between c-BCR and tu-BCR.
Intraoperative tu-BCR monitoring in female patients is applicable during lumber spine surgery.
Results date posted
| 2020 | Year | 12 | Month | 28 | 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
| 2015 | Year | 11 | Month | 11 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 05 | Day |
Anticipated trial start date
| 2015 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 12 | Day |
Last modified on
| 2021 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022825
