Female Catheters for Urinary Retention

Overseen By Zahra Bahrani-Mostafvai, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Severe urinary abnormalities, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

17 Participants Needed

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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

Required to adhere to the intervention procedure and not participate in any other clinical studies throughout the duration of this study

I am female.

I've been using catheters to empty my bladder for at least a month.

Exclusion Criteria

I am currently receiving treatment for a urinary tract infection.

Hypersensitive to the ingredients in the catheters being tested

Being pregnant or breastfeeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants will perform intermittent self-catheterization using two different catheters in a crossover design

1 day

1 visit (in-person)

Follow-up

Participants receive a follow-up telephone call to monitor any issues or side effects

1 week

1 call (telephone)

What Are the Treatments Tested in This Trial?

Interventions

• Coloplast Micro Zone Luja Female Catheter
• Coloplast SpeediCath Female Catheter

Trial Overview

The study compares two female catheters: the '14 Fr Two Eyelet Coloplast Female SpeediCath' and the '14 Fr Coloplast Micro Zone Luja.' It measures how fast urine flows using each catheter.

How Is the Trial Designed?

Group I: Luja / SpeediCath Active Control 2 Interventions

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.

Group II: SpeediCath / Luja Active Control 2 Interventions

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.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10730013/

Feasibility study on a new enhanced device for patients with ...

Hydrophilic ICs tended to decrease the incidence of UTIs and hematuria and to improve patient satisfaction compared to non-hydrophilic IC.

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S2772973724002650

A Narrative Review of Micro-hole Zone Technology

This study demonstrated the benefits of the MHZT catheter in terms of significantly reduced flow-stops and significantly reduced RV1 after both HCP-led and self ...

3.

products.coloplast.us

products.coloplast.us/coloplast/continence-care/luja-coude/luja-female/?srsltid=AfmBOoroNL3NBZ-fYAPdjUa-8iTrbcfBoL6uB0W7_nlBYlvbkfu8iWka

Luja™ female

1) Luja™ female ensured zero flow stops in 87% of catheterizations & < 10 ml residual urine at first flow stop in 83% of catheterizations (RCTs, post-hoc, NCT ...

4.

withpower.com

withpower.com/trial/phase-urinary-retention-8-2025-7ce75

Female Catheters for Urinary Retention · Info for Participants

What data supports the effectiveness of the treatment Coloplast Micro Zone Luja Female Catheter and Coloplast SpeediCath Female Catheter for urinary retention?

5.

britishjournalofnursing.com

britishjournalofnursing.com/content/product-focus/product-evaluation-of-the-luja-micro-hole-zone-technology-in-clean-intermittent-self-catheterisation

Product evaluation of the Luja Micro-hole Zone ...

A catheter with new Micro-hole Zone Technology has been developed, which can potentially improve bladder emptying and minimise these ...

6.

medicaleshop.com

medicaleshop.com/luja-female-hydrophilic-catheter?srsltid=AfmBOopVmE9WWI5iOkJ1IFNy3YhtRYhot0FprS61q5BxgqoY2HWXCbBk

Luja Female Hydrophilic Intermittent Catheter - Coloplast

Coloplast Luja Female Catheter with Micro-hole Zone Technology enables complete bladder emptying in one flow, reducing UTI risk and simplifying ...

7.

products.coloplast.us

products.coloplast.us/coloplast/continence-care/luja-coude/luja-female/?srsltid=AfmBOordKhykxVaMNvvwJtAfqhpNMIQo6SD4H747I-smqjGFO0NZKMRB

Luja™ female

1) Luja™ female ensured zero flow stops in 87% of catheterizations & < 10 ml residual urine at first flow stop in 83% of catheterizations (RCTs, post-hoc, ...

8.

products.coloplast.us

products.coloplast.us/global/meet-luja-female/?srsltid=AfmBOoofzhqiJvmz3q7QZfpp6lRqa_j2VvYMNssuQ7ILWQIwZiXRsMQs

Meet Luja™ female

Study supported by Coloplast. Luja female ensured zero flow stops in 87% of catheterizations & <10 mL residual urine at first flow stop in 83% of ...

9.

coloplastprofessional.us

coloplastprofessional.us/bladder/campaign-pages/luja-female/

Luja Female - Coloplast Professional

Luja female is indicated for use by patients with urine retention and patients with a post void residual volume (PVR) due to neurogenic and non-neurogenic ...

10.

byramhealthcare.com

byramhealthcare.com/luja-coude

Coloplast Luja® Intermittent Catheter

Individual results may vary. Luja female ensured zero flow stops in 87% of catheterizations & <10 mL residual urine at first flow stop in 83% of ...