UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038513 |
|---|---|
| Receipt number | R000043887 |
| Scientific Title | The efficacy of the cognitive behavioral therapy for overactive bladder in women: a randomized controlled trial |
| Date of disclosure of the study information | 2019/12/01 |
| Last modified on | 2023/08/06 10:46:04 |
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Basic information
Public title
The efficacy of the cognitive behavioral therapy for overactive bladder in women: a randomized controlled trial
Acronym
The efficacy of the cognitive behavioral therapy for overactive bladder in women: a randomized controlled trial
Scientific Title
The efficacy of the cognitive behavioral therapy for overactive bladder in women: a randomized controlled trial
Scientific Title:Acronym
The efficacy of the cognitive behavioral therapy for overactive bladder in women: a randomized controlled trial
Region
| Japan |
Condition
Condition
Overactive bladder
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of cognitive behavioral therapy for overactive bladder in women.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
HRQoL total score of Overactive bladder questionnaire (OAB-q)
Key secondary outcomes
1. The other score of Overactive bladder questionnaire (OAB-q)
2. Overactive bladder symptom score (OABSS)
3. King's health questionnaire (KHQ)
4. Patient Global Impression-Improvement (PGI-I)
5. Patient Global Impression-Severity (PGI-S)
4. Euroqol-5D-5L (EQ-5D-5L)
5. Hospital Anxiety and Depression Scale (HADS)
6. Frequency volume chart
7. Participant satisfaction
8. Change of drug therapy
9. Adherence of treatment
10. Drop-out rate
11. Adverse events
12. Participant feedback
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
Cognitive behavioral therapy for overactive bladder in women (30 minutes/ session, once a week, total 4 sessions)
Interventions/Control_2
Waiting list
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
| 80 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Patients with no treatment or more than 6 weeks pharmacotherapy for OAB.
2. Participants diagnosed as OAB by OAB symptom score (OABSS) and total score is more than 6 points (moderate or more).
3. Fully active, able to carry on all pre-disease performance without restriction (ECOG Performance Status: Grade 0).
4. Participants who understand explanation and obtain written informed consent.
Key exclusion criteria
1. Participants has abnormality around the bladder (e.g., bladder stone, urethral stone, interstitial cystitis, endometriosis, pelvic organ prolapse).
2. Participant is diagnosed as Urinary Tract Infection (UTI).
3. Participants who have had surgery for urinary incontinence.
4. Pregnant or possibly pregnant participants.
5. Participants who can not understand the notation of Japanese.
6. Participants with depressed tendency.
7. Participants who are diagnosed as dementia.
8. Participants who are considered as inappropriate for this study by the responsible doctor
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Ogawa |
Organization
Kyoto University, Graduate School of Medicine
Division name
Urology
Zip code
606-8507
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-3337
ogawao@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Funada |
Organization
Kyoto University, Graduate School of Medicine
Division name
Urology
Zip code
606-8507
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL
050-5374-4457
Homepage URL
http://oab-cbt.jp
OAB.CBT@gmail.com
Sponsor or person
Institute
Department of Urology, Kyoto University, Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
donation money for research
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
Ethics Committee Graduate School and Faculty of Medicine Kyoto University
Address
Yoshida, Konoe-cho, Sakyo-ku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-u.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
京都大学医学部附属病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
https://bmcurol.biomedcentral.com/articles/10.1186/s12894-020-00697-0
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
79
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
| 2019 | Year | 11 | Month | 14 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 15 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 16 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 02 | Month | 05 | Day |
Date trial data considered complete
| 2023 | Year | 02 | Month | 05 | Day |
Date analysis concluded
| 2023 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 11 | Month | 07 | Day |
Last modified on
| 2023 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043887
| Research Plan | |
|---|---|
| Registered date | File name |
| 2023/08/06 | Protocol.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2023/08/06 | data_anonymous_specification_20230806.xlsx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2023/08/06 | data_anonymous_20230806.xlsx |
