Exploratory Investigation on Performance and Safety of Newly Developed Intermittent Catheters in Female Users of Intermittent Catheters
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Retention, Urinary
- Sponsor
- Coloplast A/S
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Residual Urine at 1st Flow-stop During Nurse Catheterization
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Minimum 18 years of age and with full legal capacity
- •Daily intermittent catheterization for bladder management, with at least two catheters used on average pr. day, during the last 3 months
- •Ability to self-catheterize
- •Written informed consent, signed letter of authority and signed secrecy agreement given
Exclusion Criteria
- •Breastfeeding
- •Pregnancy (based on pregnancy test - urine)
- •Participation in any other clinical study during this investigation
- •Symptoms of urinary tract infection as judged by the investigator
- •Any know allergies towards ingredients in the products
- •Relevant medical history that would prevent the subject from participation (investigators judgement)
Outcomes
Primary Outcomes
Residual Urine at 1st Flow-stop During Nurse Catheterization
Time Frame: Immediately after the procedure/catheterization, up to 5 min.
The residual urine at 1st flow-stop during nurse catheterization (i.e., catheterization performed by the 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.
Residual Urine at 1st Flow-stop During Self-catheterization
Time Frame: Immediately after the procedure/catheterization, up to 5 min.
The residual urine at 1st flow-stop during self-catheterization (i.e., catheterization performed by the participant) 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 After Self-catheterization(Immediately after the procedure/catheterization, up to 15 min.)
- Insertion Discomfort During Nurse Catheterization(Immediately after the procedure/catheterization, up to 5 min.)
- Urination Discomfort During Self-catheterization(Immediately after the procedure/catheterization, up to 5 min.)
- Withdrawal Discomfort During Self-catheterization(Immediately after the procedure/catheterization, up to 5 min.)
- Post-void Residual Urine After Nurse Catheterization(Immediately after the procedure/catheterization, up to 15 min.)
- Withdrawal Discomfort During Nurse Catheterization(Immediately after the procedure/catheterization, up to 5 min.)
- Urination Discomfort During Nurse Catheterization(Immediately after the procedure/catheterization, up to 5 min.)
- Overall Discomfort During Self-catheterization(Immediately after the procedure/catheterization, up to 5 min.)
- Overall Discomfort During Nurse Catheterization(Immediately after the procedure/catheterization, up to 5 min.)
- Insertion Discomfort During Self-catheterization(Immediately after the procedure/catheterization, up to 5 min.)