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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036110
Receipt No. R000041136
Scientific Title Study on the effectiveness of Core Lower Urinary Tract Symptom Score(CLSS) in patients with acute uncomplicated cystitis
Date of disclosure of the study information 2019/03/06
Last modified on 2019/03/06

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Basic information
Public title Study on the effectiveness of Core Lower Urinary Tract Symptom Score(CLSS) in patients with acute uncomplicated cystitis
Acronym Study on the effectiveness of Core Lower Urinary Tract Symptom Score(CLSS) in patients with acute uncomplicated cystitis
Scientific Title Study on the effectiveness of Core Lower Urinary Tract Symptom Score(CLSS) in patients with acute uncomplicated cystitis
Scientific Title:Acronym Study on the effectiveness of Core Lower Urinary Tract Symptom Score(CLSS) in patients with acute uncomplicated cystitis
Region
Japan

Condition
Condition Acute cystitis
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate the usefulness of Core Lower Urinary Tract Symptom Score(CLSS) in patients with acute uncomplicated cystitis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change of CLSS score from baseline to 1 week.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria (1)Patients with acute uncomplicated cystitis
(2)Female aged 20 years old or more
(3)
1.Patients with any of the following bladder irrititive symptom: urinary frequency, urinary urgency, feeling of incomplete emptying, bladder pain, urethral pain.
2.Pyuria: microscopic examination of urinary sediment >=5 WBC/hpf.
(4)Written informed consent.
Key exclusion criteria (1)Presence of systemic factor(diabete mellitus, administration of steroid/immunosuppressant etc.) to exacerbate infection.
(2)Symptoms of urinary tract infection or administration of antibiotics within 4 weeks prior to onset of the present infection.
(3)Patiens who is considered to be inappropriate for the study by investigator.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoya Masumori
Organization Sapporo Medical University School of Medicine
Division name Department of Urology
Zip code
Address S-1, W-16, Chuo-ku, Sapporo, Japan
TEL 011-611-2111
Email masumori@sapmed.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhiro Nakane
Organization Sapporo Medical University School of Medicine
Division name Department of clinical reseach
Zip code
Address S-1, W-16, Chuo-ku, Sapporo, Japan
TEL 011-611-2111
Homepage URL
Email k.nakane@sapmed.ac.jp

Sponsor
Institute Sapporo Medical University School of Medicine
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
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
2019 Year 03 Month 06 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 Open public recruiting
Date of protocol fixation
2019 Year 01 Month 10 Day
Date of IRB
Anticipated trial start date
2019 Year 01 Month 10 Day
Last follow-up date
2020 Year 03 Month 06 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information unpublished

Management information
Registered date
2019 Year 03 Month 06 Day
Last modified on
2019 Year 03 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041136

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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