UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022369
Receipt number R000025779
Scientific Title Correlation between hysterectomy-induced detrusor underactivity and urinary neurotropine
Date of disclosure of the study information 2016/05/20
Last modified on 2022/11/23 09:08:16

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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

Obstetrics 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 or person

Institute

Nagoya University Graduate School of Medicine

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


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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025779


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name