Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
ID06918067

Comparison of Urinary Flow Speed Using 14 Fr Two Eyelet Coloplast Female SpeediCath Catheter Versus 14 Fr Coloplast Micro Zone Luja Catheter in Female Patients Using Intermittent Catheters

Led by Wake Forest University Health Sciences · Updated on 2026-03-05

17

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to compare the urinary flow speeds of two different female catheters in women who use intermittent catheters to empty their bladder. The study focuses on evaluating the "14 Fr Two Eyelet Coloplast Female SpeediCath Urinary Catheter" against the "14 Fr Coloplast Micro Zone Luja Female Catheter" to understand differences in flow speed and patient satisfaction. Participants will be women who regularly use intermittent catheters and are at least 18 years old. Participants will be randomly assigned to one of two groups in a crossover design. One group will first use the Luja catheter, then have their bladder backfilled with sterile fluid equal to the urine volume collected, and then use the SpeediCath catheter. The other group will perform the same steps but start with the SpeediCath catheter first. These procedures will be done during one study visit, and outcomes will be measured using an office uroflow device. Each participant will take part in a single study visit lasting about an hour, followed by a telephone call approximately one week later. During the visit, researchers will measure various urinary flow parameters such as flow duration, peak flow rate, and total urine volume. Patient satisfaction with each catheter type will also be assessed. This study does not include long-term follow-up or additional treatment periods.

CONDITIONS

Brief Title

Comparison of Urinary Flow Study

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female
  • Regular use of intermittent catheters to empty bladder for at least 1 month before enrolment
  • Age 18 years or older
  • Must adhere to the study procedures and not participate in other clinical studies during this study
Not Eligible

You will not qualify if you...

  • Severe urinary tract abnormalities such as excess urinary mucus, sediments, or debris
  • Hypersensitivity to ingredients in the tested catheters
  • Recent surgery within the past 3 months
  • Currently being treated for urinary tract infection
  • Pregnant or breastfeeding
  • Non-English speaking

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 1 day

Participants perform two different self-catheterization procedures using two types of female catheters in a randomized order during a single office visit. Urinary flow speed and satisfaction are measured.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

Women's Center for Pelvic Health (Mercy)

Charlotte, North Carolina, United States, 28207

Actively Recruiting

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Research Team

M

Michael Kennelly, MD

Z

Zahra Bahrani-Mostafvai, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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