UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036110 |
|---|---|
| Receipt number | 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 | 2023/04/05 14:00:08 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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 | Naoya |
| Middle name | |
| Last name | Masumori |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Urology
Zip code
0608543
Address
S-1, W-16, Chuo-ku, Sapporo, Japan
TEL
011-611-2111
masumori@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Nakane |
Organization
Sapporo Medical University School of Medicine
Division name
Department of clinical reseach
Zip code
0608543
Address
S-1, W-16, Chuo-ku, Sapporo, Japan
TEL
011-611-2111
Homepage URL
k.nakane@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University School of Medicine
Institute
Department
Personal name
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
Sapporo Medical University School of Medicine
Address
S-1, W-16, Chuo-ku, Sapporo, Jap
Tel
011-611-2111
k.nakane@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
| 2019 | Year | 03 | Month | 06 | Day |
Related information
URL releasing protocol
https://journals.lww.com/cur/Fulltext/9900/Difference_in_symptom_manifestation_between.110.aspx
Publication of results
Published
Result
URL related to results and publications
https://journals.lww.com/cur/Fulltext/9900/Difference_in_symptom_manifestation_between.110.aspx
Number of participants that the trial has enrolled
60
Results
Overall, the main finding of our study was that premenopausal women had more severe urethral pain
than postmenopausal women. In contrast, postmenopausal women had more severe nocturia, urgency, and urgency incontinence at
baseline and showed persistent nocturia at subsequent visits than premenopausal women.
Results date posted
| 2023 | Year | 04 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 04 | Month | 03 | Day |
Baseline Characteristics
adult female aged 20 or more
Participant flow
Initially, 73 women were enrolled in this study. Of these, 7 were excluded
because they did not meet the inclusion criteria in 5 and no
growth of bacteria in 2; subsequently, 6 were excluded from the analysis
because of persistent pyuria after antibiotic treatment.
Finally, 60 women (14 premenopausal and 46 postmenopausal) were analyzed in this study
Adverse events
none
Outcome measures
The CLSS total score changed from 13 to 4. At baseline nocturia, urgency, 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 premenopausal 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
Completed
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
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
published
Management information
Registered date
| 2019 | Year | 03 | Month | 06 | Day |
Last modified on
| 2023 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041136
