NCT04557787

Investigation of Non-CE Marked Intermittent Catheters for Females

Exploratory Investigation on Performance and Safety of Newly Developed Intermittent Catheters in Female Users of Intermittent Catheters

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Coloplast A/S · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Investigation of novel non-CE marked intermittent catheters. The study was a randomized, single blinded, cross-over investigation comparing two new catheters for females with a comparator catheter.

Detailed description

The CP324 study investigated a novel non-CE marked intermittent catheter, designed in two different variants, Variant 1 and Variant 2, respectively, and was conducted in Denmark. The study was a randomized, single blinded, cross-over investigation comparing the two new variant catheters with a comparator catheter in 15 female IC users. For each participant, the study thus contained three test visits/treatment arms (Comparator, Variant 1 and Variant 2, respectively), to which the 15 participants were randomized using a randomization sequence of six (i.e., there were six different random options for the order in which the participants tested the three catheters). There were 4-14 days between the test visits.

Conditions

• Retention, Urinary

Interventions

Type	Name	Description
DEVICE	SpeediCath® Standard female	Intermittent catheterization through the urethra draining the bladder, using SpeediCath® Standard female.
DEVICE	New intermittent Variant 1 catheter for females	Intermittent catheterization through the urethra draining the bladder, using the new Variant 1 catheter.
DEVICE	New intermittent Variant 2 catheter for females	Intermittent catheterization through the urethra draining the bladder, using the new Variant 2 catheter.

Timeline

• Start date: 2020-12-01
• Primary completion: 2021-05-31
• Completion: 2021-05-31
• First posted: 2020-09-22
• Last updated: 2023-09-21
• Results posted: 2023-09-21

Locations

1 site across 1 country: Denmark