UMIN-CTR Clinical Trial

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	Obsterics 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
Email	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
Email	imai-uro@fmu.ac.jp

Sponsor
Institute	Department of Urology, Fukushima Medical University School of Medicine
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055887