UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041719 |
|---|---|
| Receipt number | R000047623 |
| Scientific Title | Bladder irrigation with povidone-iodine prevent recurrent urinary tract infections in neurogenic bladder patients on clean intermittent catheterization |
| Date of disclosure of the study information | 2020/09/08 |
| Last modified on | 2020/09/08 05:51:51 |
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Basic information
Public title
Bladder irrigation with povidone-iodine
Acronym
BIWPI
Scientific Title
Bladder irrigation with povidone-iodine prevent recurrent urinary tract infections in neurogenic bladder patients on clean intermittent catheterization
Scientific Title:Acronym
BIWPINBP
Region
| Asia(except Japan) |
Condition
Condition
Urinary tract infection in neurogenic bladder patients
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
determine if daily povidone-iodine (PI) bladder irrigation in NB patients doing CIC can reduce the rate of symptomatic urinary tract infections(UTIs),emergency department visit for UTIs, and hospitalization for UTIs
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
UTI'S, ED visits for UTI's, Hospitalization for UTI's before and after bladder irrigation with povidone iodine
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Povidone iodine bladder irrigation
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
| 18 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
neurogenic bladder of any etiology with bladder drainage managed with clean intermittent catheterization(CIC), age>18 years old, time doing CIC>12 months, not taking antibiotic prophylaxis for urinary tract infections (UTI). Patients had recurrent UTI (>3 per year), used at least for 6 months the PI solution and with at least a period of follow-up of 12 months
Key exclusion criteria
patients receiving short-term instillations of Povidone-iodine (PI), <12months follow-up, discontinuation of CIC, < 3UTI episodes during the last 12 months, doing CIC using multiple-use polyvinylchloride catheters, patients unable to report urinary symptoms accurately, patients with hypersensitivity or allergic reaction to PI, patients with pre-existing thyroid disease or patients with creatinine level > 2mg/dl
Target sample size
119
Research contact person
Name of lead principal investigator
| 1st name | Mohamad |
| Middle name | Walid |
| Last name | Abou Chakra |
Organization
Al Zahraa Hospital
Division name
Urology
Zip code
1108
Address
Beirut, Lebanon
TEL
0096171613732
mohamedabouchakra@hotmail.com
Public contact
Name of contact person
| 1st name | Mohamad |
| Middle name | Ahmad |
| Last name | Moussa |
Organization
Al Zahraa Hospital
Division name
Urology
Zip code
1108
Address
beirut, Lebanon
TEL
009613964412
Homepage URL
mohamadamoussa@hotmail.com
Sponsor or person
Institute
Al zahraa hospital
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
Al zahraa Hospital
Address
Beirut, Lebanon
Tel
009611851040ext3365
IRB-zahraa@outlook.com
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
| 2020 | Year | 09 | Month | 08 | 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
119
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
Completed
Date of protocol fixation
| 2013 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2013 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2014 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 15 | Day |
Date of closure to data entry
| 2020 | Year | 01 | Month | 27 | Day |
Date trial data considered complete
| 2020 | Year | 01 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 08 | Month | 23 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 09 | Month | 08 | Day |
Last modified on
| 2020 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047623
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
