UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038513
Receipt No. 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 2019/11/07

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 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
Email 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 075-751-3337
Homepage URL
Email sfunada@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Urology, Kyoto University, Graduate School of Medicine
Institute
Department

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
Email 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
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 Preinitiation
Date of protocol fixation
2019 Year 11 Month 14 Day
Date of IRB
Anticipated trial start date
2020 Year 01 Month 06 Day
Last follow-up date
2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 11 Month 07 Day
Last modified on
2019 Year 11 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043887

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.