Investigation of New Intermittent Catheters in Healthy Volunteers

Retention, Urinary Clinical Trial

Official title:

Exploratory Investigation on Performance and Safety of New Intermittent Catheters in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04445051
• Other study ID #: CP322
• Status: Completed
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: September 1, 2020

Study information

• Verified date: August 2022
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 1, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Retention, Urinary
• Urinary Retention

Intervention

Device:
• SpeediCath® Standard male or female
Intermittent catheterization through the urethra draining the bladder, using SpeediCath® Standard male or female.
• New intermittent Variant 1 catheter for male or female
Intermittent catheterization through the urethra draining the bladder, using the new Variant 1 for male or female.
• New intermittent Variant 2 catheter for male or female
Intermittent catheterization through the urethra draining the bladder, using the new Variant 2 for male or female.

Locations

Country	Name	City	State
Denmark	Urologisk klinik, Afsnit 2112, Rigshospitalet	Copenhagen	Copenhagen Ø

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Residual Urine at 1st Flow-stop	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.	Immediately after the procedure/catheterization, up to 5 min.
Secondary	Post-void Residual Urine	The volume of residual urine (urine left in the bladder) post catheterization (performed by the nurse) measured in triplicates using an ultrasound scanner.	Immediately after the procedure/catheterization, up to 15 min.
Secondary	Catheterization Insertion Discomfort	Discomfort measured at catheter insertion, using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.	Immediately after the procedure/catheterization, up to 5 min.
Secondary	Catheterization Urination Discomfort	Discomfort measured during catheter emptying/urination, using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.	Immediately after the procedure/catheterization, up to 5 min.
Secondary	Withdrawal Discomfort	Discomfort measured during catheter withdrawal, using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.	Immediately after the procedure/catheterization, up to 5 min.
Secondary	Overall Catheterization Discomfort	Discomfort measured for the overall/entire catheterization procedure, using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.	Immediately after the procedure/catheterization, up to 5 min.
Secondary	Post-catheterization Urination Discomfort	Discomfort measured for the first normal void/urination after the catheterization procedure, using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.	Immediately after the first normal void following the procedure/catheterization, up to 5 min.