Comparison of Urinary Flow Study

Wake Forest University (WFU)

Status: Enrolling

Conditions: Urinary Retention

Treatments: Device: Coloplast Micro Zone Luja Female Catheter; Device: Coloplast SpeediCath Female Catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT06918067

IRB00128923

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 17 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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17 participants in 2 patient groups

Luja / SpeediCath

Active Comparator group

Description:

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.

Treatment:

Device: Coloplast SpeediCath Female Catheter

Device: Coloplast Micro Zone Luja Female Catheter

SpeediCath / Luja

Active Comparator group

Description:

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.

Treatment:

Device: Coloplast SpeediCath Female Catheter

Device: Coloplast Micro Zone Luja Female Catheter