UMIN-CTR Clinical Trial

Basic information
Public title	Correlation between hysterectomy-induced detrusor underactivity and urinary neurotropine
Acronym	Correlation between hysterectomy-induced detrusor underactivity and urinary neurotropine
Scientific Title	Correlation between hysterectomy-induced detrusor underactivity and urinary neurotropine
Scientific Title:Acronym	Correlation between hysterectomy-induced detrusor underactivity and urinary neurotropine
Region	Japan

Condition
Condition	uterine cervix cancer
Classification by specialty	Obsterics and gynecology Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the correlation between hysterectomy-induced underactive bladder and urinary neurotropine.
Basic objectives2	Others
Basic objectives -Others	To investigate the correlation between recovery from hysterectomy-induced underactive bladder and change in urinary neurotropine.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the correlation between reduction in bladder function one momnth after hysterectomy and change in urinary neurotropine
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	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	Pressure flow study will be performed before, one month after, and six months after the hysterectomy.
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	50 years-old >
Gender	Female
Key inclusion criteria	Patients who will undergo radical hysterectomy for uterine cervix cancer.
Key exclusion criteria	Patients who have bladder disorder, diabetic mellitus, or neurological disorder, or do not give informed consent.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yoshihisa Matsukawa
Organization	Nagoya University Graduate School of Medicine
Division name	Urology
Zip code
Address	65, Tsuruma-cho, Showa-ku,Nagoya, 466-8550
TEL	0527442984
Email	yoshi44@med.nagoya-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Tsuyoshi Majima
Organization	Nagoya University Graduate School of Medicine
Division name	Urology
Zip code
Address	65, Tsuruma-cho, Showa-ku,Nagoya, 466-8550
TEL	0527442984
Homepage URL
Email	yellowkab1979@yahoo.co.jp

Sponsor
Institute	Nagoya University Graduate School of Medicine
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
Address
Tel
Email

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	2016 Year 05 Month 20 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	Completed
Date of protocol fixation	2016 Year 05 Month 01 Day
Date of IRB	2016 Year 05 Month 25 Day
Anticipated trial start date	2016 Year 07 Month 01 Day
Last follow-up date	2022 Year 12 Month 31 Day
Date of closure to data entry	2022 Year 12 Month 31 Day
Date trial data considered complete	2022 Year 12 Month 31 Day
Date analysis concluded	2023 Year 05 Month 31 Day

Other
Other related information

Management information
Registered date	2016 Year 05 Month 19 Day
Last modified on	2022 Year 11 Month 23 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025779