UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049120 |
|---|---|
| Receipt number | R000055887 |
| Scientific Title | Lower urinary tract function in treating patients with gynecologic cancer and risk factors for postoperative underactive bladder |
| Date of disclosure of the study information | 2022/10/10 |
| Last modified on | 2022/10/04 18:13:07 |
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Basic information
Public title
Lower urinary tract function in treating patients with gynecologic cancer and risk factors for postoperative underactive bladder
Acronym
Lower urinary tract function in treating patients with gynecologic cancer and risk factors for postoperative underactive bladder
Scientific Title
Lower urinary tract function in treating patients with gynecologic cancer and risk factors for postoperative underactive bladder
Scientific Title:Acronym
Lower urinary tract function in treating patients with gynecologic cancer and risk factors for postoperative underactive bladder
Region
| Japan |
Condition
Condition
underactive bladder
cervical cancer
Classification by specialty
| Obstetrics and Gynecology | Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate risk factors for lower urinary tract dysfunction especially underactive bladder after radical hysterectomy
Basic objectives2
Others
Basic objectives -Others
To evaluate lower urinary tract function before and after radical hysterectomy and find more appropriate postoperative bladder care in women
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The factors associated with underactive bladder after radical hysterectomy
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
The patients with cervical cancer scheduled for radical hysterectomy at our hospital
Key exclusion criteria
We exclude the patients if they underwent unplanned surgery.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Kojima |
Organization
Fukushima Medical University School of Medicine
Division name
Department of Urology
Zip code
960-1295
Address
1-Hikarigaoka, Fukushima
TEL
024-547-1316
urol@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Hitomi |
| Middle name | |
| Last name | Imai |
Organization
Fukushima Medical University School of Medicine
Division name
Department of Urology
Zip code
024-547-1316
Address
1-Hikarigaoka, Fukushima
TEL
024-547-1316
Homepage URL
imai-uro@fmu.ac.jp
Sponsor or person
Institute
Department of Urology, Fukushima Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Fukushima Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukushima Medical University School of Medicine
Address
1-Hikarigaoka, Fukushima
Tel
024-547-1316
imai-uro@fmu.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
| 2022 | Year | 10 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 09 | Month | 08 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 17 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 17 | Day |
Last follow-up date
| 2030 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Before and after surgery, evaluation is carried out five times using questionnaires, urodynamics study, urinalysis, and frequency-volume chart.
Management information
Registered date
| 2022 | Year | 10 | Month | 04 | Day |
Last modified on
| 2022 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055887
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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