Skip to main content
OpenTrials
Completed

NCT Number: NCT04445051

Investigation of New Intermittent Catheters in Healthy Volunteers

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Retention, Urinary Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urinary Retention Urination Disorders Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Urologisk klinik, Afsnit 2112, Rigshospitalet

Copenhagen, Copenhagen Ø, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SpeediCath® Standard male or female

Device

Intermittent catheterization through the urethra draining the bladder, using SpeediCath® Standard male or female.

New intermittent Variant 1 catheter for male or female

Device

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

Device

Intermittent catheterization through the urethra draining the bladder, using the new Variant 2 for male or female.

Primary outcomes

  1. 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

  1. Post-void Residual Urine

    Time frame: Immediately after the procedure/catheterization, up to 15 min.

    The volume of residual urine (urine left in the bladder) post catheterization (performed by the nurse) measured in triplicates using an ultrasound scanner.

  2. Catheterization Insertion Discomfort

    Time frame: Immediately after the procedure/catheterization, up to 5 min.

    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.

  3. Catheterization Urination Discomfort

    Time frame: Immediately after the procedure/catheterization, up to 5 min.

    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.

  4. Withdrawal Discomfort

    Time frame: Immediately after the procedure/catheterization, up to 5 min.

    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.

  5. Overall Catheterization Discomfort

    Time frame: Immediately after the procedure/catheterization, up to 5 min.

    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.

  6. Post-catheterization Urination Discomfort

    Time frame: Immediately after the first normal void following the procedure/catheterization, up to 5 min.

    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.

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 24, 2020
Registry last updated
Jul 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.