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NCT06918067NARecruiting

Comparison of Urinary Flow Study

Wake Forest University Health Sciences

Start Date

11/6/2025

Completion Date

3/1/2027

Summary

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.

Detailed Description

The purpose of this crossover study is to compare the urinary flow speed of two different female catheters manufactured by Coloplast, the "14 Fr Two Eyelet Coloplast Female SpeediCath Urinary Catheter" vs "14 Fr Coloplast Micro Zone Luja Female Catheter" in patients that use intermittent catheters to empty their bladder. Patients will be randomly assigned to group A or group B using a closed-envelope randomization method. Group A will self catheter with Luja, backfill with sterile fluid volume equal to amount of urine collected, then self-catheter with SpeediCath. Group B will self catheter with SpeediCath, backfill with sterile fluid volume equal to amount of urine collected, then self-catheter with Luja. Outcomes will be measured with office uroflow device.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DEVICE

Coloplast Micro Zone Luja Female Catheter

DEVICE

Coloplast SpeediCath Female Catheter

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Conditions

Urinary Retention

Locations

Women's Center for Pelvic Health (Mercy)

Charlotte, North Carolina 28207

United States