Female Catheters for Urinary Retention
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to compare the urinary flow speed of two different female catheters: the Coloplast SpeediCath and the Coloplast Micro Zone Luja. Researchers seek to determine which catheter more effectively aids women who regularly use intermittent catheters to empty their bladder. Participants will try both catheters during a single visit and receive a follow-up call a week later. Women who have used intermittent catheters for at least a month and can adhere to the study procedures are well-suited for this trial. As an unphased trial, this study offers participants the chance to contribute to valuable research that may enhance catheter options for women.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications.
What prior data suggests that these female catheters are safe for use?
Research has shown that both the Coloplast Micro Zone Luja Female Catheter and the Coloplast SpeediCath Female Catheter are safe for individuals with urine retention. The Luja Catheter ensures smooth urine flow in 87% of uses, reducing leftover urine and lowering the risk of urinary tract infections (UTIs). The SpeediCath Catheter also serves those with ongoing urine retention. Both catheters are intended for intermittent use, meaning they are used only when needed and not left in place. They are sterile and designed for one-time use, which helps prevent infections. While results can vary among individuals, current evidence supports the safe use of both catheters for managing urine retention.12345
Why are researchers excited about this trial?
Researchers are excited about the Coloplast Micro Zone Luja Female Catheter and the Coloplast SpeediCath Female Catheter because these devices aim to improve the experience of intermittent self-catheterization for women with urinary retention. Unlike some traditional catheters that may be less comfortable or harder to use, the Luja catheter features a unique micro-zone technology that could potentially make insertion smoother and more comfortable. The SpeediCath is known for its ready-to-use design, which doesn't require additional lubrication, making the process quicker and more convenient. Both catheters offer the possibility of enhancing patient comfort and ease of use, which are key factors in managing urinary retention effectively.
What evidence suggests that these catheters are effective for urinary retention?
This trial will compare the Coloplast Micro Zone Luja Female Catheter and the Coloplast SpeediCath Female Catheter. Studies have shown that the Coloplast Micro Zone Luja Female Catheter aids in emptying the bladder by reducing interruptions in urine flow. Specifically, 87% of users did not experience any flow interruptions, and most had less than 10 ml of urine left in the bladder, which can lead to greater satisfaction and fewer infections. In contrast, the Coloplast SpeediCath Female Catheter is known for its safety and comfort. Research indicates it also lowers the risk of urinary tract infections, particularly for individuals with spinal injuries. Both catheters aim to improve urine flow and reduce health issues related to catheter use.678910
Who Is on the Research Team?
Michael Kennelly, MD
Principal Investigator
Wake Forest University Health Sciences
Are You a Good Fit for This Trial?
This trial is for women who use intermittent catheters to manage urinary retention. Participants will have one study visit lasting about an hour and a follow-up call after a week.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants will perform intermittent self-catheterization using two different catheters in a crossover design
Follow-up
Participants receive a follow-up telephone call to monitor any issues or side effects
What Are the Treatments Tested in This Trial?
Interventions
- Coloplast Micro Zone Luja Female Catheter
- Coloplast SpeediCath Female Catheter
Find a Clinic Near You
Who Is Running the Clinical Trial?
Wake Forest University Health Sciences
Lead Sponsor