UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046376 |
|---|---|
| Receipt number | R000052921 |
| Scientific Title | Comparison of vaginal and intestinal bacteria between patients with recurrent cystitis and patients with non-repetitive cystitis and patients with non-cystitis in postmenopausal women |
| Date of disclosure of the study information | 2021/12/14 |
| Last modified on | 2024/12/16 10:15:04 |
* 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
Comparison of vaginal and intestinal bacteria between patients with recurrent cystitis and patients with non-repetitive cystitis and patients with non-cystitis in postmenopausal women
Acronym
Comparison of vaginal and intestinal bacteria between cystitis and non-cystitis patients in postmenopausal women
Scientific Title
Comparison of vaginal and intestinal bacteria between patients with recurrent cystitis and patients with non-repetitive cystitis and patients with non-cystitis in postmenopausal women
Scientific Title:Acronym
Comparison of vaginal and intestinal bacteria between cystitis and non-cystitis patients in postmenopausal women
Region
| Japan |
Condition
Condition
Postmenopausal patients visiting an outpatient urology department
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to compare the vaginal and intestinal bacteria of patients with recurrent cystitis, patients with non-repetitive cystitis, and patients with non-cystitis to determine whether patients with recurrent cystitis can be predicted.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Differences in vaginal and intestinal flora in patients with recurrent cystitis, patients with non-repetitive cystitis, and patients with non-cystitis
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1.Female patients who visit the urology outpatient department between December 31, 2025 after the approval of the Ethics Committee
2.Patients who can voluntarily obtain consent to participate in the research in writing from the patient
3.Patients who are menopausal at the time of obtaining consent
Key exclusion criteria
1.A woman whose vagina and anus are closed
2.Patients with uterine cancer who have not been hysterectomized and are being treated
3.Patients being treated for vaginitis
4.Patients who have difficulty opening their legs
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | AYANO |
| Middle name | |
| Last name | ISHII |
Organization
Okayama University Hospital
Division name
Integrated Support Center for Patients and Self-learning
Zip code
700-8558
Address
2-5-1,Shikata,Kita-ku,Okayama
TEL
0862357844
ishii-a@cc.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | AYANO |
| Middle name | |
| Last name | ISHII |
Organization
Okayama University Hospital
Division name
Integrated Support Center for Patients and Self-learning
Zip code
700-8558
Address
2-5-1,Shikata,Kita-ku,Okayama
TEL
0862357844
Homepage URL
ishii-a@cc.okayama-u.ac.jp
Sponsor or person
Institute
Department of Urology,Okayama University Graduate School of Medicine,Dentistry and Pharmaceutical Sciences
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address
2-5-1,Shikata,Kita-ku,Okayama
Tel
0862356938
mae6605@adm.okayama-u.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
| 2021 | Year | 12 | Month | 14 | 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
29
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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 10 | Month | 26 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 07 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 13 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Insert a thin cotton swab into the patient's vagina or rectum and wipe the secretions with a cotton swab to investigate the bacteria present in the specimen. We will investigate the difference in vaginal and intestinal bacterial flora by the next-generation sequencer and the difference in pathogenicity of E. coli in the intestine by experiments.
Management information
Registered date
| 2021 | Year | 12 | Month | 14 | Day |
Last modified on
| 2024 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052921
