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

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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 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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name