Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
17 participants
INTERVENTIONAL
2025-11-06
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
NONE
Study Groups
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Luja / SpeediCath
Subjects randomized to this arm will perform intermittent self-catheterization using the Coloplast Micro Zone Luja Female Catheter first then have bladder backfilled with sterile fluid to the amount equal to the volume of first catheterization. Then the subject will perform intermittent self-catheterization using the Coloplast Female SpeediCath Urinary Catheter.
Coloplast Micro Zone Luja Female Catheter
clean self-catheterization with 14 Fr Coloplast micro zone Luja female urinary catheter
Coloplast SpeediCath Female Catheter
clean self-catheterization with 14 Fr two eyelet Coloplast SpeediCath female urinary catheter
SpeediCath / Luja
Subject randomized to this arm will perform intermittent self-catheterization using the Coloplast Female SpeediCath Urinary Catheter first then have bladder backfilled with sterile fluid to the amount equal to the volume of first catheterization. Then the subject will perform intermittent self-catheterization using the Coloplast Micro Zone Luja Female Catheter.
Coloplast Micro Zone Luja Female Catheter
clean self-catheterization with 14 Fr Coloplast micro zone Luja female urinary catheter
Coloplast SpeediCath Female Catheter
clean self-catheterization with 14 Fr two eyelet Coloplast SpeediCath female urinary catheter
Interventions
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Coloplast Micro Zone Luja Female Catheter
clean self-catheterization with 14 Fr Coloplast micro zone Luja female urinary catheter
Coloplast SpeediCath Female Catheter
clean self-catheterization with 14 Fr two eyelet Coloplast SpeediCath female urinary catheter
Eligibility Criteria
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Inclusion Criteria
* Regular use of intermittent catheters to empty bladder, for at least 1 month before enrolment
* Age 18 years or older
* Required to adhere to the intervention procedure and not participate in any other clinical studies throughout the duration of this study
Exclusion Criteria
* Hypersensitive to the ingredients in the catheters being tested
* Recent surgery, within 3 months
* Currently being treated for urinary tract infection
* Being pregnant or breastfeeding
* Non-English speaking
18 Years
FEMALE
No
Sponsors
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Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Michael Kennelly, MD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Women's Center for Pelvic Health (Mercy)
Charlotte, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Michael Kennelly, MD
Role: primary
Other Identifiers
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IRB00128923
Identifier Type: -
Identifier Source: org_study_id