UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043168
Receipt number R000049276
Scientific Title Examination of the effect of overactive bladder treatment on female sexual function
Date of disclosure of the study information 2021/02/05
Last modified on 2024/02/02 23:20:44

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Basic information

Public title

Examination of the effect of overactive bladder treatment on female sexual function

Acronym

Examination of the effect of OAB treatment on female sexual function

Scientific Title

Examination of the effect of overactive bladder treatment on female sexual function

Scientific Title:Acronym

Examination of the effect of OAB treatment on female sexual function

Region

Japan


Condition

Condition

overactive bladder

Classification by specialty

Urology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

In clinical practice, it is a prospective evaluation of changes in sexual function in women with overactive bladder treatment.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Fill in the questionnaire before and 12 weeks after the start of drug treatment

Key secondary outcomes

At the same time, evaluate OABSS and residual urine volume


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

Treatment

Type of intervention

Medicine

Interventions/Control_1

Insured drugs for overactive bladder are given at regular doses for 24 weeks.

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


Not applicable

Gender

Female

Key inclusion criteria

(1) Overactive bladder patients (OABSS: total 3 points or more and question 3 2 points or more)
(2) Consent to include in the study has been obtained
(3) Being a new OAB treatment patient
* Even if you have a history of treatment in the past, it is good if there is nothing you are currently taking

Key exclusion criteria

(1) Underage patients or patients whose sexual function cannot be evaluated
(2) When the attending physician deems it inappropriate

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Naoya
Middle name
Last name Masumori

Organization

Sapporo Medical University

Division name

Department of Urology

Zip code

060-8543

Address

South 1 West 16, Cyuou-ku, Sapporo, Hokkaido

TEL

011-611-2111

Email

masumori@sapmed.ac.jp


Public contact

Name of contact person

1st name Wakako
Middle name
Last name Yorozuya

Organization

Sapporo Medical University

Division name

Department of Urology

Zip code

060-8543

Address

South 1 West 16, Cyuou-ku, Sapporo, Hokkaido

TEL

011-611-2111

Homepage URL


Email

wakakoyoro@sapmed.ac.jp


Sponsor or person

Institute

Sapporo Medical University

Institute

Department

Personal name



Funding Source

Organization

Sapporo Medical University

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization



Other related organizations

Co-sponsor

Sanjyukai Hospital, Hokkaido Medical Center, NTT East Sapporo Hospital, Japan Community Health Care Organization (JCHO) Hokkaido Hospital,Oji Hospital, Muroran City General Hospital,Steel Memorial Muroran Hospital,Hakodate Goryokaku Hospital, Asahikawa Red Cross Hospital, Takikawa City Hospital,Sunagawa City Hospital, Obihiro Kyokai Hospital, Saka Urology Hospital, Kushiro Red Cross Hospital,Sapporo Central Hospital ,etc

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Sapporo Medical University

Address

South 1 West 16, Cyuou-ku, Sapporo, Hokkaido

Tel

011-611-2111

Email

ji-rskk@sapmed.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 02 Month 05 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

2019 Year 02 Month 08 Day

Date of IRB

2019 Year 03 Month 14 Day

Anticipated trial start date

2020 Year 05 Month 01 Day

Last follow-up date

2027 Year 03 Month 31 Day

Date of closure to data entry

2027 Year 06 Month 30 Day

Date trial data considered complete

2027 Year 08 Month 30 Day

Date analysis concluded

2027 Year 11 Month 30 Day


Other

Other related information



Management information

Registered date

2021 Year 01 Month 28 Day

Last modified on

2024 Year 02 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049276


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name