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NCT Number: NCT06918067

Comparison of Urinary Flow Study

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.

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Key information

Conditions

Urinary Retention Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urination Disorders Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Women's Center for Pelvic Health (Mercy)

Charlotte, North Carolina, 28207, United States

Location status: Recruiting

Location contact

Michael Kennelly, MD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coloplast Micro Zone Luja Female Catheter

Device

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

Coloplast SpeediCath Female Catheter

Device

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

Primary outcomes

  1. Urinary flow duration

    Time frame: 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.

  2. Total Urine Volume

    Time frame: Day 1

    total urine volume (mL) measured by uroflow device

  3. Peak Flow Rate

    Time frame: 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.

  4. Time to Peak Flow

    Time frame: 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.

  5. Mean Flow

    Time frame: 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.

  6. Total Urine voiding time

    Time frame: Day 1

    Total time (seconds) to void urine from beginning of urine flow to the end of flow, measured by uroflow device.

Secondary outcomes

  1. Measuring patient's satisfaction of using catheter-Part a

    Time frame: Day 1

    Patient's preference of catheter type by using the Patient Global Impression of Improvement (PGI-I) scale

  2. Measuring patient's satisfaction of using catheter-Part b

    Time frame: Day 1

    Patient's Satisfaction and Comments on Use of Luja Catheter

Study contacts

Contact information is provided by the study sponsor or research team.

Michael Kennelly, MD

CONTACT

[email protected]

704-304-1160

Zahra Bahrani-Mostafvai, PhD

CONTACT

[email protected]

704-304-1160

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 9, 2025
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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