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?

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.

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.

Is the SpeediCath Female Catheter safe for use in humans?

Research shows that the SpeediCath Female Catheter is generally safe for use, with studies indicating little to no discomfort for most users and no significant safety concerns reported. ^{1 2 3 4 5}

How does the Coloplast Micro Zone Luja Female Catheter differ from other treatments for urinary retention?

The Coloplast Micro Zone Luja Female Catheter is unique because it is designed specifically for women, offering a compact and potentially more comfortable option compared to standard-length catheters. This catheter may provide better drainage efficiency and ease of use for women experiencing urinary retention. ^{1 2 6 7 8}

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

The study comparing the SpeediCath Compact catheter to standard-length catheters suggests that the SpeediCath Compact, which is similar to the Coloplast SpeediCath Female Catheter, is effective in draining the bladder in females, indicating its potential effectiveness for urinary retention. ^{1 7 9 10 11}

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. England pubmed.ncbi.nlm.nih.gov

Residual urine after intermittent catheterization in females using two different catheters. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Fascia lata urethrovesical suspension for recurrent stress urinary incontinence. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Postoperative voiding, bacteriuria and urinary tract infection with Foley catheterization after gynecological surgery. [2015]

4. England pubmed.ncbi.nlm.nih.gov

An alternative statistical approach for predicting prolonged catheterization after Burch colposuspension during reconstructive pelvic surgery. [2019]

5. Australia pubmed.ncbi.nlm.nih.gov

Predictive factors for the success of trial catheter removal for women with urinary retention. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

An external urine-collection device for women: a clinical trial. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Evaluation of two coated catheters in intermittent self-catheterization. [2015]

8. United States pubmed.ncbi.nlm.nih.gov

Immediate urodynamic and anatomic response to colposuspension in female Beagles. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Patient-perceived discomfort with two coated urinary catheters. [2007]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of different sized transurethral catheters on pressure-flow studies in women with lower urinary tract symptoms. [2006]

11. United States pubmed.ncbi.nlm.nih.gov

Suprapubic Versus Transurethral Catheterization: Perioperative Outcomes After Colpocleisis. [2022]