Investigation of New Intermittent Catheters in Healthy Volunteers

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2020-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Investigation of Non-CE Marked Intermittent Catheters for Females

NCT04557787

Retention, Urinary

COMPLETED NA

Investigation of Non-CE Marked Intermittent Catheters.

NCT04543136

Retention, Urinary

COMPLETED NA

Clinical Study Investigating Safety and Performance of a New Urinary Intermittent Catheters in Healthy Volunteers

NCT02965105

Incontinence, Urinary

COMPLETED NA

Explorative Clinical Study on the Performance and Acceptance of New Intermittent Catheters in Healthy Volunteers

NCT04231149

Compliance, Patient

COMPLETED NA

Test Catheter Pilot Study in Healthy Volunteers

NCT00832078

Healthy

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Retention, Urinary

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intermittent catheter; SpeediCath® Standard male or female

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

Group Type ACTIVE_COMPARATOR

SpeediCath® Standard male or female

Intervention Type DEVICE

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

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.

Group Type EXPERIMENTAL

New intermittent Variant 1 catheter for male or female

Intervention Type DEVICE

Intermittent catheterization through the urethra draining the bladder, using the new Variant 1 for male or female.

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.

Group Type EXPERIMENTAL

New intermittent Variant 2 catheter for male or female

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SpeediCath® Standard male or female

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

Intervention Type DEVICE

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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes