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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013835
Receipt No. 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

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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 Obsterics 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
Email 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/
Email prj-oasis@eps.co.jp

Sponsor
Institute Oasis project
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016109

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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