Comparison of Urinary Flow Study

NCT06918067 | Recruiting FDA Device

• 1 other identifier: IRB00128923
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Retention

Keywords

catheter; intermittent catheterization; bladder

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• Measuring patient's satisfaction of using catheter-Part a

  Day 1

• Measuring patient's satisfaction of using catheter-Part b

  Day 1

Study Arms (2)

Luja / SpeediCath

ACTIVE COMPARATOR

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; Device: Coloplast SpeediCath Female Catheter

SpeediCath / Luja

ACTIVE COMPARATOR

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; Device: Coloplast SpeediCath Female Catheter

Interventions

Coloplast Micro Zone Luja Female Catheter DEVICE

clean self-catheterization with 14 Fr Coloplast micro zone Luja female urinary catheter

Luja / SpeediCath; SpeediCath / Luja

Coloplast SpeediCath Female Catheter DEVICE

clean self-catheterization with 14 Fr two eyelet Coloplast SpeediCath female urinary catheter

Luja / SpeediCath; SpeediCath / Luja

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: biologic females
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Women's Center for Pelvic Health (Mercy)

Charlotte, North Carolina, 28207, United States

RECRUITING

MeSH Terms

Conditions

Urinary Retention

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Michael Kennelly, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Kennelly, MD

CONTACT

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

Zahra Bahrani-Mostafvai, PhD

CONTACT

704-304-1160; Zahra.Bahranimostafavi@atriumhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2025
• First Posted: April 9, 2025
• Study Start: November 6, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)