UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045390 |
|---|---|
| Receipt number | R000051831 |
| Scientific Title | Urinary function monitoring using electrode-equipped urethral catheter during uterine cancer surgery |
| Date of disclosure of the study information | 2021/12/01 |
| Last modified on | 2022/09/15 13:32:28 |
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Basic information
Public title
Urinary function monitoring using electrode-equipped urethral catheter during uterine cancer surgery
Acronym
Urinary function monitoring using electrode-equipped urethral catheter during uterine cancer surgery
Scientific Title
Urinary function monitoring using electrode-equipped urethral catheter during uterine cancer surgery
Scientific Title:Acronym
Urinary function monitoring using electrode-equipped urethral catheter during uterine cancer surgery
Region
| Japan |
Condition
Condition
uterine cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the usefulness of intraoperative voiding function monitoring (motor evoked potentials, bulbocavernous reflex) to avoid voiding dysfunction after wide total hysterectomy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between potential changes in intraoperative voiding function monitoring (motor evoked potential monitoring, globus pallidus reflex monitoring) and postoperative voiding function changes
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Intraoperative transcranial motor evoked potential monitoring and globus pallidus reflex monitoring using a urinary catheter with electrodes
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
| 99 | years-old | >= |
Gender
Female
Key inclusion criteria
(1) Patients scheduled for a wide total hysterectomy under general anesthesia for cervical cancer or uterine cancer
(2) 20 years of age or older (at the time of registration)
(3) Female
Key exclusion criteria
(1) Emergency surgery
(2) Patients with cardiac pacemaker implantation
(3) Patients with epilepsy
(4) Patients with manual muscle testing (MMT) grade 3 or higher lower extremity movement disorder
(5) Patients who require self-control of urine
(6) Patients with impaired consciousness
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | AYAKO |
| Middle name | |
| Last name | OI |
Organization
Nara Medical University
Division name
Anesthesia Division
Zip code
634-8521
Address
840 Shijo-cho, Kashihara City, Nara Prefecture
TEL
0744-22-3051
ayazo0520@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | AYAKO |
| Middle name | |
| Last name | OI |
Organization
Nara Medical University
Division name
Anesthesia Division
Zip code
634-8521
Address
840 Shijo-cho, Kashihara City, Nara Prefecture
TEL
0744-22-3051
Homepage URL
ayazo0520@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Address
840 Shijo-cho, Kashihara City, Nara Prefecture
Tel
0744-22-3051
ayazo0520@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
| 2021 | Year | 12 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2023 | 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
| 2021 | Year | 09 | Month | 06 | Day |
Last modified on
| 2022 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051831
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
