UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052912 |
|---|---|
| Receipt number | R000040851 |
| Scientific Title | Study on the usefulness of Core Lower Urinary Tract Symptom Score(CLSS) in patients with acute uncomplicated cystitis |
| Date of disclosure of the study information | 2023/11/27 |
| Last modified on | 2023/11/27 15:16:06 |
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Basic information
Public title
Study on the usefulness of Core Lower Urinary Tract Symptom Score(CLSS) in patients with acute uncomplicated cystitis
Acronym
Study on the usefulness of Core Lower Urinary Tract Symptom Score(CLSS) in patients with acute uncomplicated cystitis
Scientific Title
Study on the usefulness of Core Lower Urinary Tract Symptom Score(CLSS) in patients with acute uncomplicated cystitis
Scientific Title:Acronym
Study on the usefulness of Core Lower Urinary Tract Symptom Score(CLSS) in patients with acute uncomplicated cystitis
Region
| Japan |
Condition
Condition
Acute uncomplicated cystitis
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to examine 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 in Core Lower Urinary Tract Symptom Score(CLSS)
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)Any contraindication investigator specify.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Astushi |
| Middle name | |
| Last name | Wanifuchi |
Organization
Department of Urology, Sapporo Medical University School of Medicine, Sapporo, Japan
Division name
Department of Urology, Sapporo Medical University School of Medicine, Sapporo, Japan
Zip code
060-8543
Address
S1, W16, Chuo-ku, Sapporo, Hokkaido
TEL
011-611-2111
a-wanifuchi@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Wanifuchi |
Organization
Department of Urology, Sapporo Medical University School of Medicine, Sapporo, Japan
Division name
Department of Urology, Sapporo Medical University School of Medicine, Sapporo, Japan
Zip code
060-8543
Address
S1, W16, Chuo-ku, Sapporo, Hokkaido
TEL
011-611-2111
Homepage URL
a-wanifuchi@sapmed.ac.jp
Sponsor or person
Institute
Department of Urology, Sapporo Medical University School of Medicine, Sapporo, Japan
Institute
Department
Personal name
Funding Source
Organization
none
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
Department of Urology, Sapporo Medical University School of Medicine, Sapporo, Japan
Address
S1, W16, Chuo-ku, Sapporo, Hokkaido
Tel
011-611-2111
a-wanifuchi@sapmed.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 11 | Month | 27 | Day |
Related information
URL releasing protocol
https://journals.lww.com/cur/pages/default.aspx
Publication of results
Published
Result
URL related to results and publications
https://journals.lww.com/cur/pages/default.aspx
Number of participants that the trial has enrolled
66
Results
The CLSS total score changed from 13 to 4 with a significant improvement in all CLSS items. At baseline, nocturia, urgency,
and urgency incontinence were more prominent in postmenopausal women than in premenopausal women. In contrast, baseline urethral
pain and quality of life index were more severe in postmenopausal women than in postmenopausal women. After treatment, the
CLSS total score was still higher in postmenopausal women.
Results date posted
| 2023 | Year | 11 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Materials and methods: This study included adult women with acute uncomplicated cystitis who visited 4 institutions between 2019
and 2020. After registration, we administered oral antibiotics and prospectively documented the changes in lower urinary tract symptoms
from the first visit to a follow-up visit at 1 week using the Core Lower Urinary Tract Symptoms Score (CLSS) questionnaire.
Participant flow
Materials and methods: This study included adult women with acute uncomplicated cystitis who visited 4 institutions between 2019
and 2020. After registration, we administered oral antibiotics and prospectively documented the changes in lower urinary tract symptoms
from the first visit to a follow-up visit at 1 week using the Core Lower Urinary Tract Symptoms Score (CLSS) questionnaire.
Adverse events
none
Outcome measures
The CLSS total score (range) changed from 13 to 4 with a significant improvement in all CLSS items. At baseline, nocturia, urgency,
and urgency incontinence were more prominent in postmenopausal women than in premenopausal women. In contrast, baseline urethral
pain and quality of life index were more severe in postmenopausal women than in postmenopausal women. After treatment, the
CLSS total score was still higher in postmenopausal women.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2019 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
no data
Management information
Registered date
| 2023 | Year | 11 | Month | 27 | Day |
Last modified on
| 2023 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040851
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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