Exploratory Investigation on Performance and Safety of New Intermittent Catheters in Healthy Volunteers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Coloplast A/S
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Residual Urine at 1st Flow-stop
Study Overview
Brief Summary
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Intermittent catheter; SpeediCath® Standard male or female
Participants underwent catheterization with standard of care intermittent catheter. The catheterization was performed by a trained nurse.
Intervention: SpeediCath® Standard male or female (Device)
New intermittent catheter Variant 1 for male or female
Participants underwent catheterization with the new intermittent catheter Variant 1 for males or females. The catheterization was performed by a trained nurse.
Intervention: New intermittent Variant 1 catheter for male or female (Device)
New intermittent catheter Variant 2 for male or female
Participants underwent catheterization with the new intermittent catheter Variant 2 for males or females. The catheterization was performed by a trained nurse.
Intervention: New intermittent Variant 2 catheter for male or female (Device)
Outcomes
Primary Outcomes
Residual Urine at 1st Flow-stop
Time Frame: Immediately after the procedure/catheterization, up to 5 min.
The residual urine at 1st flow-stop during catheterization (performed by a nurse) represents the volume of urine left in the bladder, the first time the urine stops running out of the catheter during bladder emptying/urination. This was assessed using a pressure sensor with time-logged weighing, meaning that a flow-stop was registered measuring the hydrostatic pressure at the outlet of an intermittent urinary catheter. Simultaneously, the collected urine was weighed and converted to volume, and the residual volume at first flow stop was calculated as the difference between the total urine volume collected and the volume collected at the first flow-stop.
Secondary Outcomes
- Post-void Residual Urine(Immediately after the procedure/catheterization, up to 15 min.)
- Withdrawal Discomfort(Immediately after the procedure/catheterization, up to 5 min.)
- Post-catheterization Urination Discomfort(Immediately after the first normal void following the procedure/catheterization, up to 5 min.)
- Catheterization Insertion Discomfort(Immediately after the procedure/catheterization, up to 5 min.)
- Catheterization Urination Discomfort(Immediately after the procedure/catheterization, up to 5 min.)
- Overall Catheterization Discomfort(Immediately after the procedure/catheterization, up to 5 min.)