UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013649 |
|---|---|
| Receipt number | R000015932 |
| Scientific Title | PROSPECTIVE RANDOMIZED STUDY OF POLYDIMETHYLSILOXANE VS HYALURONIC ACID INJECTION FOR TREATMENT OF VESICOURETERAL REFLUX |
| Date of disclosure of the study information | 2014/04/06 |
| Last modified on | 2014/04/06 10:22:35 |
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Basic information
Public title
PROSPECTIVE RANDOMIZED STUDY OF POLYDIMETHYLSILOXANE VS HYALURONIC ACID INJECTION FOR TREATMENT OF VESICOURETERAL REFLUX
Acronym
Polydimethylsiloxane vs. hyaluronic acid comparison
Scientific Title
PROSPECTIVE RANDOMIZED STUDY OF POLYDIMETHYLSILOXANE VS HYALURONIC ACID INJECTION FOR TREATMENT OF VESICOURETERAL REFLUX
Scientific Title:Acronym
Polydimethylsiloxane vs. hyaluronic acid comparison
Region
| North America |
Condition
Condition
Vesicoureteral reflux
Classification by specialty
| Nephrology | Infectious disease | Pediatrics |
| Urology | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In our prospective study using a single injection of either substance performed by a single surgeon, we aimed to compare the effectiveness and complications of polydimethylsiloxane vs hyaluronic acid injection for the endoscopic treatment of VUR.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary outcome was surgical success (resolution vs. non resolution).
Key secondary outcomes
Secondary outcomes included the occurrence of adverse events.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Endoscopic injection of polydimethylsiloxane (macro plastique)
Interventions/Control_2
Endoscopic injection of hyaluronic acid (deflux)
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
| 0 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Diagnosis of vesicoureteral reflux (VUR) using voiding cystouretrogram (VCUG),
Key exclusion criteria
Previous endoscopic treatment of VUR
Active urinary tract infection at the time of injection Untreated bladder or bowel dysfunction
Absence of follow-up imaging studies (US and/or VCUG) 3 months following the injection procedure
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katherine Moore |
Organization
CHU de Quebec, CHUL
Division name
Pediatric Urology
Zip code
Address
2705 boul. Laurier R-1742 Quebec, Quebec, Canada, G1V 4G2
TEL
418-654-2282
katherine.moore.1@ulaval.ca
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katherine Moore |
Organization
CHU de Quebec
Division name
Pediatric Urology
Zip code
Address
2705 boul. Laurier R-1742 Quebec, Quebec, Canada, G1V 4G2
TEL
418-654-2282
Homepage URL
http://www2.chudequebec.ca
katherine.moore.1@ulaval.ca
Sponsor or person
Institute
CHU de Quebec
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
B13-08-1783
Org. issuing International ID_1
CHU de Quebec
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
CHU de Quebec, pavillon CHUL, Department of Surgery, Division of Urology, Universite Laval, Quebec City , Canada
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | Month | 06 | 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
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
No longer recruiting
Date of protocol fixation
| 2005 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 06 | Day |
Last modified on
| 2014 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015932
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
