UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013835 |
|---|---|
| Receipt number | R000016109 |
| Scientific Title | A questionnaire survey on the patient's subjective symptoms and the treatment reality of overactive bladder and hypertension. |
| Date of disclosure of the study information | 2014/04/30 |
| Last modified on | 2015/04/30 13:12:15 |
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Basic information
Public title
A questionnaire survey on the patient's subjective symptoms and the treatment reality of overactive bladder and hypertension.
Acronym
OASIS Project
Scientific Title
A questionnaire survey on the patient's subjective symptoms and the treatment reality of overactive bladder and hypertension.
Scientific Title:Acronym
OASIS Project
Region
| Japan |
Condition
Condition
Overactive bladder / Nocturia
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
| Nephrology | Neurology | Psychosomatic Internal Medicine |
| Geriatrics | Obstetrics and Gynecology | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The research focuses on patient's satisfaction levels for treatment of overactive bladder with nocturia, and the relationship with OAB, nocturia, hypertension. Using this result, consider modalities of medical future.
Basic objectives2
Others
Basic objectives -Others
Close relationships with overactive bladder, nocturia, caldiovascular disease, hypertension, and their treatment regimen
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Study 1.
Patients satisfaction levels for treatment of lower urinary symptom evaluated by IPSS-QOL and their quality of life (KHQ), and the relationship with their symptom described below:
1)Overactive bladder symptom score: OABSS, International Prostate Symptom Score: IPSS, Frequency volume chart: FVC
2)Blood pressure control status
3)The combination of anti-hypertensive drugs and anti-overactive bladder drugs
Their symptom evaluated by OABSS, IPSS and FVC, and the relationship with their treatment status described below:
1)Blood pressure control status: presence/absence of hypertension, types of anti-hypertensive drug
2)Types of anti-hypertensive drug and anti-overactive drug and their combination.
Study 2.
Changes from baseline (study 1) to 3 month treatment of any intervention were evaluated and determine the relationship with each parameter.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Study 1.
1)male and female OAB patients aged >=40 years with nocturia, evaluated using the Overactive Bladder Symptom Score [OABSS]
2)Patients who are able to understand study procedures and agree to participate in the study by written informed consent or oral informed consent.
3)Patients who are able to answer the Data query form, judged by physician.
Study 2.
1)Patients who met the entry criteria for study 1, and agree to participate in the study 2.
2)IPSS-QOL score is four or more.
3)Treatment of alpha-blocker more than one month at the study 1 in patients with BPH.
Key exclusion criteria
Study 1.
1) Strong suspect of prostate cancer and any other urinary malignancy.
2) Patients with multiple sclerosis, spinal cord injury or parkinson's disease.
3) Patients with urethral stricture.
4) Patients with history of prostate surgery within six months.
5) Patients with urinary tract infection or urinary stone.
6) Patients with interstitial cystitis or chronic prostatitis.
7) Indwelling catheter or self intermittent urinary catherization
8) Any other patients who are regarded as unsuitable for this study by the investigator.
Study 2.
1)Same as study 1.
2)Residual urine >=100mL
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osamu Yokoyama |
Organization
Faculty of Medical Science, University of Fukui
Division name
Urology
Zip code
Address
23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshuda-gun,Fukui 910-1193, Japan
TEL
0776-61-8396
oyoko@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun Okada |
Organization
Oasis project's office
Division name
EPS Corporation
Zip code
Address
8F, Iidabashi MF Bldg, 1-1 Shinogawamachi, Shinjuku-ku, Tokyo, 168-0814, Japan
TEL
070-5553-3489
Homepage URL
http://www.oasis-project.jp/
prj-oasis@eps.co.jp
Sponsor or person
Institute
Oasis project
Institute
Department
Personal name
Funding Source
Organization
The Kidney Foundation, Japan
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2014 | Year | 04 | Month | 30 | 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
Completed
Date of protocol fixation
| 2012 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 28 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 08 | Month | 31 | Day |
Other
Other related information
Relevance of patient satisfaction with current treatment.
Management information
Registered date
| 2014 | Year | 04 | Month | 28 | Day |
Last modified on
| 2015 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016109
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