UMIN-CTR 臨床試験登録情報の閲覧

一般向け試験名/Public title

日本語
急性単純性膀胱炎における主要下部尿路症状スコア(CLSS)の有用性の検討

英語
Study on the usefulness of Core Lower Urinary Tract Symptom Score(CLSS) in patients with acute uncomplicated cystitis

一般向け試験名略称/Acronym

日本語
急性単純性膀胱炎における主要下部尿路症状スコア(CLSS)の有用性の検討

英語
Study on the usefulness of Core Lower Urinary Tract Symptom Score(CLSS) in patients with acute uncomplicated cystitis

科学的試験名/Scientific Title

日本語
急性単純性膀胱炎における主要下部尿路症状スコア(CLSS)の有用性の検討

英語
Study on the usefulness of Core Lower Urinary Tract Symptom Score(CLSS) in patients with acute uncomplicated cystitis

科学的試験名略称/Scientific Title:Acronym

日本語
急性単純性膀胱炎における主要下部尿路症状スコア(CLSS)の有用性の検討

英語
Study on the usefulness of Core Lower Urinary Tract Symptom Score(CLSS) in patients with acute uncomplicated cystitis

試験実施地域/Region

日本/Japan

対象疾患名/Condition

日本語
急性単純性膀胱炎

英語
Acute uncomplicated cystitis

疾患区分1/Classification by specialty

泌尿器科学/Urology

疾患区分2/Classification by malignancy

悪性腫瘍以外/Others

ゲノム情報の取扱い/Genomic information

いいえ/NO

目的1/Narrative objectives1

日本語
急性単純性膀胱炎における主要下部尿路症状スコア(CLSS)の有用性を検討する

英語
The aim of this study is to examine the usefulness of Core Lower Urinary Tract Symptom Score(CLSS) in patients with acute uncomplicated cystitis

目的2/Basic objectives2

有効性/Efficacy

目的2 -その他詳細/Basic objectives -Others

日本語

英語

試験の性質1/Trial characteristics_1

試験の性質2/Trial characteristics_2

試験のフェーズ/Developmental phase

主要アウトカム評価項目/Primary outcomes

日本語
主要下部尿路症状スコア(CLSS)の変化

英語
Change in Core Lower Urinary Tract Symptom Score(CLSS)

副次アウトカム評価項目/Key secondary outcomes

日本語

英語

試験の種類/Study type

観察/Observational

基本デザイン/Basic design

ランダム化/Randomization

ランダム化の単位/Randomization unit

ブラインド化/Blinding

コントロール/Control

層別化/Stratification

動的割付/Dynamic allocation

試験実施施設の考慮/Institution consideration

ブロック化/Blocking

割付コードを知る方法/Concealment

群数/No. of arms

介入の目的/Purpose of intervention

介入の種類/Type of intervention

介入1/Interventions/Control_1

日本語

英語

介入2/Interventions/Control_2

日本語

英語

介入3/Interventions/Control_3

日本語

英語

介入4/Interventions/Control_4

日本語

英語

介入5/Interventions/Control_5

日本語

英語

介入6/Interventions/Control_6

日本語

英語

介入7/Interventions/Control_7

日本語

英語

介入8/Interventions/Control_8

日本語

英語

介入9/Interventions/Control_9

日本語

英語

介入10/Interventions/Control_10

日本語

英語

年齢（下限）/Age-lower limit

20

歳/years-old

以上/<=

年齢（上限）/Age-upper limit

適用なし/Not applicable

性別/Gender

女/Female

選択基準/Key inclusion criteria

日本語
(1)尿路に基礎疾患を有さない急性単純性膀胱炎患者
(2)20歳以上の成人女性。
(3)①膀胱刺激症状のいずれかを有する (頻尿、尿意切迫感、残尿感、 　　
膀胱痛、尿道痛など主治医が有症状と判断した症例)
②膿尿：尿沈渣検鏡≧5WBCs/hpf
(4)試験組み入れへの同意が得られている。

英語
(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.

除外基準/Key exclusion criteria

日本語
(1)糖尿病、ステロイド・免疫抑制剤投与など感染症を増悪する全身性素因を有する症例。
(2)今回の発症4週間以内に膀胱炎症状、抗菌薬投与を有した症例。
(3)その他主治医が不適当と判断した症例

英語
(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.

目標参加者数/Target sample size

50

責任研究者/Name of lead principal investigator

日本語

名	Atsushi
ミドルネーム
姓	Wanifuchi

英語

名	Astushi
ミドルネーム
姓	Wanifuchi

所属組織/Organization

日本語
Department of Urology, Sapporo Medical University School of Medicine, Sapporo, Japan

英語
Department of Urology, Sapporo Medical University School of Medicine, Sapporo, Japan

所属部署/Division name

日本語
Department of Urology, Sapporo Medical University School of Medicine, Sapporo, Japan

英語
Department of Urology, Sapporo Medical University School of Medicine, Sapporo, Japan

郵便番号/Zip code

060-8543

住所/Address

日本語
S1, W16, Chuo-ku, Sapporo, Hokkaido

英語
S1, W16, Chuo-ku, Sapporo, Hokkaido

電話/TEL

011-611-2111

Email/Email

a-wanifuchi@sapmed.ac.jp

試験問い合わせ窓口担当者/Name of contact person

日本語

名	Atsushi
ミドルネーム
姓	Wanifuchi

英語

名	Atsushi
ミドルネーム
姓	Wanifuchi

組織名/Organization

日本語
Department of Urology, Sapporo Medical University School of Medicine, Sapporo, Japan

英語
Department of Urology, Sapporo Medical University School of Medicine, Sapporo, Japan

部署名/Division name

日本語
Department of Urology, Sapporo Medical University School of Medicine, Sapporo, Japan

英語
Department of Urology, Sapporo Medical University School of Medicine, Sapporo, Japan

郵便番号/Zip code

060-8543

住所/Address

日本語
S1, W16, Chuo-ku, Sapporo, Hokkaido

英語
S1, W16, Chuo-ku, Sapporo, Hokkaido

電話/TEL

011-611-2111

試験のホームページURL/Homepage URL

Email/Email

a-wanifuchi@sapmed.ac.jp

機関名/Institute

日本語
その他

英語
Department of Urology, Sapporo Medical University School of Medicine, Sapporo, Japan

機関名/Institute
（機関選択不可の場合）

日本語
Department of Urology, Sapporo Medical University School of Medicine, Sapporo, Japan

部署名/Department

日本語

個人名/Personal name

日本語

英語

機関名/Organization

日本語
無し

英語
none

機関名/Organization
（機関選択不可の場合）

日本語
Department of Urology, Sapporo Medical University School of Medicine, Sapporo, Japan

組織名/Division

日本語

組織の区分/Category of Funding Organization

その他/Other

研究費拠出国/Nationality of Funding Organization

日本語

英語

共同実施組織/Co-sponsor

日本語

英語

その他の研究費提供組織/Name of secondary funder(s)

日本語

英語

組織名/Organization

日本語
Department of Urology, Sapporo Medical University School of Medicine, Sapporo, Japan

英語
Department of Urology, Sapporo Medical University School of Medicine, Sapporo, Japan

住所/Address

日本語
S1, W16, Chuo-ku, Sapporo, Hokkaido

英語
S1, W16, Chuo-ku, Sapporo, Hokkaido

電話/Tel

011-611-2111

Email/Email

a-wanifuchi@sapmed.ac.jp

他機関から発行された試験ID/Secondary IDs

いいえ/NO

試験ID1/Study ID_1

ID発行機関1/Org. issuing International ID_1

日本語

英語

試験ID2/Study ID_2

ID発行機関2/Org. issuing International ID_2

日本語

英語

治験届/IND to MHLW

試験実施施設名称/Institutions

一般公開日（本登録希望日）/Date of disclosure of the study information

2023

年

11

月

27

日

プロトコル掲載URL/URL releasing protocol

https://journals.lww.com/cur/pages/default.aspx

試験結果の公開状況/Publication of results

最終結果が公表されている/Published

結果掲載URL/URL related to results and publications

https://journals.lww.com/cur/pages/default.aspx

組み入れ参加者数/Number of participants that the trial has enrolled

66

主な結果/Results

日本語
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.

英語
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.

主な結果入力日/Results date posted

2023

年

11

月

27

日

結果掲載遅延/Results Delayed

結果遅延理由/Results Delay Reason

日本語

英語

最初の試験結果の出版日/Date of the first journal publication of results

参加者背景/Baseline Characteristics

日本語
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.

英語
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.

参加者の流れ/Participant flow

日本語
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.

英語
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.

有害事象/Adverse events

日本語
none

英語
none

評価項目/Outcome measures

日本語
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.

英語
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.

個別症例データ共有計画/Plan to share IPD

日本語

英語

個別症例データ共有計画の詳細/IPD sharing Plan description

日本語

英語

試験進捗状況/Recruitment status

主たる結果の公表済み/Main results already published

プロトコル確定日/Date of protocol fixation

2019

年

01

月

10

日

倫理委員会による承認日/Date of IRB

2019

年

01

月

10

日

登録・組入れ開始（予定）日/Anticipated trial start date

2019

年

01

月

10

日

フォロー終了(予定)日/Last follow-up date

2021

年

03

月

31

日

入力終了(予定)日/Date of closure to data entry

データ固定（予定）日/Date trial data considered complete

解析終了(予定)日/Date analysis concluded

その他関連情報/Other related information

日本語
なし

英語
no data

登録日時/Registered date

2023

年

11

月

27

日

最終更新日/Last modified on

2023

年

11

月

27

日

閲覧ページへのリンク/Link to view the page

日本語
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000040851

英語
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040851