Comparison of Urinary Flow Study

Part of paid clinical trials in Charlotte, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT06918067
Status
Recruiting
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Conditions

  • Urinary Retention

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Coloplast Micro Zone Luja Female Catheter — DEVICE
    clean self-catheterization with 14 Fr Coloplast micro zone Luja female urinary catheter
  • Coloplast SpeediCath Female Catheter — DEVICE
    clean self-catheterization with 14 Fr two eyelet Coloplast SpeediCath female urinary catheter

Study Details

The purpose of this research study is to compare the urinary flow speed of two different female catheters in patients that use intermittent catheters to empty their bladder. The "14 Fr Two Eyelet Coloplast Female SpeediCath Urinary Catheter" will be compared to the "14 Fr Coloplast Micro Zone Luja Female Catheter." Participants will have one study visit that should take about an hour and will also receive a follow-up telephone call about one week after the visit.

Key Dates

Start date
Nov 6, 2025
Status verified
Mar 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
17 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: 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.
  • Active Comparator: 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.

Primary Outcome Measure

Urinary flow duration [ Time Frame: Day 1 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Women's Center for Pelvic Health (Mercy)CharlotteNorth Carolina28207
Michael Kennelly, MD
[email protected]

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Women's Center for Pelvic Health (Mercy)· Charlotte, NC

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