Investigation of Non-CE Marked Intermittent Catheters for Females

NCT ID: NCT04557787

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2021-05-31

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.

Conditions

Retention, Urinary

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Intermittent catheter; SpeediCath® Standard female

Participants underwent two catheterizations with standard of care intermittent catheter: The first was performed by a trained nurse, the second by the participant later the same day.

Group Type: ACTIVE_COMPARATOR

SpeediCath® Standard female

Intervention Type: DEVICE

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

New intermittent catheter Variant 1 for females

Participants underwent two catheterizations with the new intermittent catheter variant 1 for females: The first was performed by a trained nurse, the second by the participant later the same day.

Group Type: EXPERIMENTAL

New intermittent Variant 1 catheter for females

Intervention Type: DEVICE

Intermittent catheterization through the urethra draining the bladder, using the new Variant 1 catheter.

New intermittent catheter Variant 2 for females

Participants underwent two catheterizations with the new intermittent catheter variant 2 for females: The first was performed by a trained nurse, the second by the participant later the same day.

Group Type: EXPERIMENTAL

New intermittent Variant 2 catheter for females

Intervention Type: DEVICE

Intermittent catheterization through the urethra draining the bladder, using the new Variant 2 catheter.

Interventions

SpeediCath® Standard female

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

Intervention Type: DEVICE

New intermittent Variant 1 catheter for females

Intermittent catheterization through the urethra draining the bladder, using the new Variant 1 catheter.

Intervention Type: DEVICE

New intermittent Variant 2 catheter for females

Intermittent catheterization through the urethra draining the bladder, using the new Variant 2 catheter.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Female
• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Coloplast A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Per Bagi, MD

Role: PRINCIPAL_INVESTIGATOR

Blegdamsvej 9, Urologisk klinik Afsnit 2112, Rigshospitalet, Denmark

Locations

Urologisk klinik, Afsnit 2112, Rigshospitalet

Copenhagen, , Denmark

Countries

Denmark

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CP324

Identifier Type: -

Identifier Source: org_study_id