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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000045390
Receipt No. 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 2021/09/06

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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
Obsterics 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
Email 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
Email ayazo0520@naramed-u.ac.jp

Sponsor
Institute Nara Medical University
Institute
Department

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
Email 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
2022 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
2021 Year 09 Month 06 Day


Link to view the page
URL(English) 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
Registered date File name

Research case data
Registered date File name


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