UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035734 |
|---|---|
| Receipt number | R000040707 |
| Scientific Title | The feasibility and efficacy of the combination with behavioral therapy and psychological intervention for drug-resistant overactive bladder: a single-arm clinical trial |
| Date of disclosure of the study information | 2019/02/01 |
| Last modified on | 2021/08/07 17:39:52 |
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Basic information
Public title
The feasibility and efficacy of the combination with behavioral therapy and psychological intervention for drug-resistant overactive bladder: a single-arm clinical trial
Acronym
The feasibility and efficacy of the combination with behavioral therapy and psychological intervention for drug-resistant overactive bladder: a single-arm clinical trial
Scientific Title
The feasibility and efficacy of the combination with behavioral therapy and psychological intervention for drug-resistant overactive bladder: a single-arm clinical trial
Scientific Title:Acronym
The feasibility and efficacy of the combination with behavioral therapy and psychological intervention for drug-resistant overactive bladder: a single-arm clinical trial
Region
| Japan |
Condition
Condition
Overactive bladder
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility and efficacy of combination with behavioral therapy and psychological intervention for drug-resistant overactive bladder
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Drop out rate
2. Overactive bladder questionnaire (OAB-q)
Key secondary outcomes
1. Overactive bladder symptom score (OABSS)
2. King's health questionnaire (KHQ)
3. Global Improvement Scale (GIS)
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. Adverse events
10. Participant feedback
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
Combination with behavioral and psychological therapy for drug-resistant overactive bladder (30 minutes/ session, once a week, total 6 sessions)
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
| 80 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Patients diagnosed as OAB and receiving pharmacological therapy for more than 12 weeks.
2. Participants remains OAB symptom, the total point of overactive bladder symptom score (OABSS) 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 anxiety/ depressed tendency (Hospitality Anxiety and Depression Scale (HADS) is more than 21 point).
7. Participants who are diagnosed as dementia.
8. Participants who are considered as inappropriate for this study by the responsible doctor
Target sample size
15
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
075-751-3337
Homepage URL
sfunada@kuhp.kyoto-u.ac.jp
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 | 02 | Month | 01 | Day |
Related information
URL releasing protocol
no releasing
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/abs/10.1111/luts.12333
Number of participants that the trial has enrolled
10
Results
HRQoL total score of OAB-q improved from 56.2 points SD 22.1) at baseline to 81.4 points (SD 20.1) at week 11. The mean difference of HRQoL total score of OABq between baseline to week 11 was 25.2 points (SD 25.2), which was larger than the MCID. The other domains of OABq also improved from baseline to week 11. The effect size (Cohen's d) increased from 0.75 to 1.73, meaning the effect was moderate to large.
Results date posted
| 2021 | Year | 08 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 07 | Month | 03 | Day |
Baseline Characteristics
Median age was 72 years (range 53 to 80 years) and median OABSS was 9 points (range 6 to 12 points) at baseline. Median age at onset of OAB was 68 years (range 50 to 70 years) and median duration of treatment for OAB was 5.5 years (range 1 to 14 years). No participant used anticholinergics and all used B3 agonist for the treatment of OAB.
Participant flow
Ten patients participated in this study. Two participants dropped out of the study. One patient dropped out because of left lower limb pain caused by surgery two years prior, and another patient was unable to come to the hospital because she changed her job.
Adverse events
There were no adverse events associated with the intervention during the study.
Outcome measures
OAB-q, KHQ, OABSS, HADS, EQ-5D-5L, FVC, GIS, Satisfaction, Adverse events
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 01 | Month | 16 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 16 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 13 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 18 | Day |
Date of closure to data entry
| 2019 | Year | 12 | Month | 18 | Day |
Date trial data considered complete
| 2019 | Year | 12 | Month | 18 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 31 | Day |
Last modified on
| 2021 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040707
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