Comparison of Urinary Flow Study

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

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.

Study Overview

• Status: Recruiting
• Conditions: Urinary Retention
• Intervention / Treatment: Device: Coloplast Micro Zone Luja Female Catheter; Device: Coloplast SpeediCath Female Catheter

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 Type: Interventional
• Enrollment (Estimated): 17
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael Kennelly, MD; Phone Number: 704-304-1160; Email: michael.kennelly@atriumhealth.org
• Study Contact Backup: Name: Zahra Bahrani-Mostafvai, PhD; Phone Number: 704-304-1160; Email: Zahra.Bahranimostafavi@atriumhealth.org

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Recruiting
      • Women's Center for Pelvic Health (Mercy)
      • Contact: Michael Kennelly, MD; Email: Michael.Kennelly@atriumhealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: Coloplast Micro Zone Luja Female Catheter; clean self-catheterization with 14 Fr Coloplast micro zone Luja female urinary catheter; Device: Coloplast SpeediCath Female Catheter; clean self-catheterization with 14 Fr two eyelet Coloplast SpeediCath female 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.	Device: Coloplast Micro Zone Luja Female Catheter; clean self-catheterization with 14 Fr Coloplast micro zone Luja female urinary catheter; Device: Coloplast SpeediCath Female Catheter; clean self-catheterization with 14 Fr two eyelet Coloplast SpeediCath female urinary catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary flow duration	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.	Day 1
Total Urine Volume	total urine volume (mL) measured by uroflow device	Day 1
Peak Flow Rate	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.	Day 1
Time to Peak Flow	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.	Day 1
Mean Flow	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.	Day 1
Total Urine voiding time	Total time (seconds) to void urine from beginning of urine flow to the end of flow, measured by uroflow device.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measuring patient's satisfaction of using catheter-Part a	Patient's preference of catheter type by using the Patient Global Impression of Improvement (PGI-I) scale	Day 1
Measuring patient's satisfaction of using catheter-Part b	Patient's Satisfaction and Comments on Use of Luja Catheter	Day 1

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Michael Kennelly, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: April 3, 2025
• First Submitted That Met QC Criteria: April 4, 2025
• First Posted (Actual): April 9, 2025

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: bladder; catheter; intermittent catheterization
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Urinary Retention
• Other Study ID Numbers: IRB00128923

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No