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 | 2025/01/31 09:45:30 |
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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 12 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
50
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
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
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
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
| 2025 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049276
