Comparison of Urinary Flow Study

Not Applicable

Not yet recruiting

• Conditions: Urinary Retention

• Registration Number: NCT06918067
• Lead Sponsor: Wake Forest University Health Sciences

Brief 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.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-04-03
• Study First Submitted QC: 2025-04-04
• Last Update Submitted: 2025-04-04
• Study First Posted: 2025-04-09
• Last Update Posted: 2025-04-09
• Study Start: 2025-09
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Urinary flow duration	Day 1	Amount of time (seconds) it takes the urine to be released. The normal urinary flow duration for women is 15-18 ml/sec. A lower average flow rate could indicate a problem with the bladder or urinary tract.

Secondary Outcome Measures

Name	Time	Method
Total Urine Volume	Day 1	total urine volume (mL) measured by uroflow device
Peak Flow Rate	Day 1	Peak flow (mL/sec) measured by uroflow device. Normal peak urine flow rates typically range from 15 to 25 mL/sec for women. Reduced flow rates or a slow stream can indicate urinary tract obstruction or other issues.
Time to Peak Flow	Day 1	Time (seconds) to peak flow measured by uroflow device. A normal peak flow rate for women is typically between 15 and 25 mL/sec. A lower rate may indicate a blockage or obstruction in the urinary tract.
Mean Flow	Day 1	Mean flow (mL/sec) measured by uroflow device. Normal mean urine flow rates typically range from 15 to 25 mL/sec for women. A slow or low flow rate may mean there is an obstruction at the bladder neck or in the urethra or a weak bladder.

Trial Locations

Locations (1)

Women's Center for Pelvic Health (Mercy); 🇺🇸 Charlotte, North Carolina, United States