Investigation of New Intermittent Catheters in Healthy Volunteers

Coloplast

Status: Completed

Conditions: Retention, Urinary

Treatments: Device: New intermittent Variant 2 catheter for male or female; Device: New intermittent Variant 1 catheter for male or female; Device: SpeediCath® Standard male or female

Study type: Interventional

Funder types: Industry

Identifiers

NCT04445051

CP322

Details and patient eligibility

About

Investigation of non-CE marked intermittent catheters. The study was a randomized, single blinded, cross-over investigation comparing two new catheters with a comparator catheter in 30 adult healthy volunteers.

Full description

The CP322 study investigated a novel non-CE marked intermittent catheter for males and females, designed in two different variants, Variant 1 and Variant 2, respectively. The study was conducted in Denmark and was a randomized, single blinded, cross-over investigation comparing the two new variant catheters with a comparator catheter in 30 adult healthy volunteers.

For each participant, the study thus contained three test visits/treatment arms (Comparator, Variant 1 and Variant 2, respectively), to which the 30 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Minimum 18 years of age and with full legal capacity
• Written informed consent and signed letter of authority and secrecy agreement given
• Willing to comply with not using analgesics 1 up to 24 hours prior to catheterization visits
• Urine Multistix negative for erythrocytes (hematuria)

Exclusion criteria

• Participation in any other clinical investigations during this investigation
• Known hypersensitivity towards any of the test products
• Symptoms of urinary tract infection (UTI) (Investigators judgement)
• Pregnancy or breastfeeding

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

30 participants in 3 patient groups

Intermittent catheter; SpeediCath® Standard male or female

Active Comparator group

Description:

Participants underwent catheterization with standard of care intermittent catheter. The catheterization was performed by a trained nurse.

Treatment:

Device: SpeediCath® Standard male or female

New intermittent catheter Variant 1 for male or female

Experimental group

Description:

Participants underwent catheterization with the new intermittent catheter Variant 1 for males or females. The catheterization was performed by a trained nurse.

Treatment:

Device: New intermittent Variant 1 catheter for male or female

New intermittent catheter Variant 2 for male or female

Experimental group

Description:

Participants underwent catheterization with the new intermittent catheter Variant 2 for males or females. The catheterization was performed by a trained nurse.

Treatment:

Device: New intermittent Variant 2 catheter for male or female