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Standard of Care for Neurogenic Bladder (ConCaRe™ Trial)
N/A
Recruiting
Led By Diane Newman, D.N.P. F.A.A.N. B.C.B.-P.M.D.
Research Sponsored by Hollister Incorporated
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Summary
This observational research study aims to build a multinational electronic patient-reported outcomes (ePRO) registry of adult end users in outpatient and community settings using intermittent catheter(s) to void via the urethra to manage urinary retention and incomplete bladder emptying. Research participants will be asked to self-report on various attributes of their currently prescribed intermittent catheters and other various aspects of using an intermittent catheter.
Eligible Conditions
- Neurogenic Bladder
- Overactive Bladder
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Creation of longitudinal continence care ePRO-based, direct-to-consumer registry
Secondary outcome measures
Identification of intermittent self-catheterization habits and behaviors
Trial Design
1Treatment groups
Experimental Treatment
Group I: Standard of CareExperimental Treatment1 Intervention
Individuals using an intermittent catheter to void urine through the urethra. Participants use their currently prescribed intermittent catheter per their clinician's standard of care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intermittent Catheter
2017
N/A
~40
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Who is running the clinical trial?
Hollister IncorporatedLead Sponsor
13 Previous Clinical Trials
1,169 Total Patients Enrolled
ParexelIndustry Sponsor
308 Previous Clinical Trials
100,551 Total Patients Enrolled
Technomics ResearchIndustry Sponsor
3 Previous Clinical Trials
183 Total Patients Enrolled
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