Comparison of urinary flow with two female intermittent catheters
Official title: Comparison of Urinary Flow Speed Using 14 Fr Two Eyelet Coloplast Female SpeediCath Urinary Catheter Versus 14 Fr Coloplast Micro Zone Luja Female Catheter in Female Patients Using Intermittent Catheters
Run by Wake Forest University Health Sciences · NCT06918067 · Data updated 2026-11-12
This test will see if two different female intermittent catheters produce different urinary flow speeds in adults who regularly catheterize.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 17 (estimated) |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 1 site (Charlotte, North Carolina) |
| Status | Recruiting |
| Started | November 6, 2025 |
| Main results expected | March 2027 |
| Study ends | March 2027 |
| Registry record updated | March 5, 2026 |
| Trial ID | NCT06918067 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18 or older who have been regularly using intermittent catheterization for at least one month and can attend a single in-person visit are ideal candidates.
✕Probably not a fit
People with severe urinary tract abnormalities, current urinary tract infection, recent surgery, pregnancy or breastfeeding, hypersensitivity to catheter ingredients, or inability to follow the procedures may not receive benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized crossover comparison of two 14 Fr female catheters made by Coloplast, the Two Eyelet SpeediCath and the Micro Zone Luja. Participants are randomly assigned to one of two sequences, self-catheterize with the first device, have the bladder backfilled with sterile fluid equal to the urine collected, then self-catheterize with the second device. Urinary flow outcomes are measured during a single office visit using an uroflowmetry device, and participants receive a follow-up phone call about one week later. The crossover design lets each participant serve as her own control to compare flow speed between the two catheters.
Why it matters
Potential benefit: If successful, the results could help people who catheterize choose a catheter that empties the bladder faster or more efficiently.
How similar studies have gone: Prior crossover comparisons of catheter designs have been performed and sometimes show small differences in flow or usability, so this approach builds on modest prior evidence rather than being entirely novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female * 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: * Severe urinary tract abnormalities (e.g. excessive production of urinary mucus/sediments/debris) * 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
Where it's running
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Women's Center for Pelvic Health (Mercy)
Charlotte, North Carolina, United States Recruiting
Study contacts
- Principal investigator: Michael Kennelly, MD — Wake Forest University Health Sciences
- Study coordinator: Michael Kennelly, MD
- Email: michael.kennelly@atriumhealth.org
- Phone: 704-304-1160
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.