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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000041719
Receipt No. 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

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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
Email 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
Email mohamadamoussa@hotmail.com

Sponsor
Institute Al zahraa hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047623

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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