RecruitingNot Applicable

Comparison of Urinary Flow Study

United States17 participantsStarted 2025-11-06

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Urinary flow duration

Timeframe: Day 1

Total Urine Volume

Timeframe: Day 1

Peak Flow Rate

Timeframe: Day 1

Time to Peak Flow

Timeframe: Day 1

Mean Flow

Timeframe: Day 1

Total Urine voiding time

Timeframe: Day 1

Trial details

NCT IDNCT06918067

SponsorWake Forest University Health Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-03

Contact for this trial

Michael Kennelly, MD

704-304-1160 michael.kennelly@atriumhealth.org

View on ClinicalTrials.gov More Urinary Retention trials