Investigation of Non-CE Marked Intermittent Catheters for Females
Exploratory Investigation on Performance and Safety of Newly Developed Intermittent Catheters in Female Users of Intermittent Catheters
1 other identifier
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 2, 2020
CompletedFirst Posted
Study publicly available on registry
September 22, 2020
CompletedStudy Start
First participant enrolled
December 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2021
CompletedResults Posted
Study results publicly available
September 21, 2023
CompletedSeptember 21, 2023
September 1, 2023
6 months
September 2, 2020
August 15, 2022
September 20, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Residual Urine at 1st Flow-stop During Nurse Catheterization
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.
Immediately after the procedure/catheterization, up to 5 min.
Residual Urine at 1st Flow-stop During Self-catheterization
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.
Immediately after the procedure/catheterization, up to 5 min.
Secondary Outcomes (10)
Post-void Residual Urine After Nurse Catheterization
Immediately after the procedure/catheterization, up to 15 min.
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 Nurse Catheterization
Immediately after the procedure/catheterization, up to 5 min.
Withdrawal Discomfort During Nurse Catheterization
Immediately after the procedure/catheterization, up to 5 min.
- +5 more secondary outcomes
Study Arms (3)
Intermittent catheter; SpeediCath® Standard female
ACTIVE COMPARATORParticipants 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.
New intermittent catheter Variant 1 for females
EXPERIMENTALParticipants 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.
New intermittent catheter Variant 2 for females
EXPERIMENTALParticipants 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.
Interventions
Intermittent catheterization through the urethra draining the bladder, using SpeediCath® Standard female.
Intermittent catheterization through the urethra draining the bladder, using the new Variant 1 catheter.
Intermittent catheterization through the urethra draining the bladder, using the new Variant 2 catheter.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Coloplast A/Slead
Study Sites (1)
Urologisk klinik, Afsnit 2112, Rigshospitalet
Copenhagen, 2100, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Vice President, Medical Affairs
- Organization
- Coloplast A/S
Study Officials
- PRINCIPAL INVESTIGATOR
Per Bagi, MD
Blegdamsvej 9, Urologisk klinik Afsnit 2112, Rigshospitalet, Denmark
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 2, 2020
First Posted
September 22, 2020
Study Start
December 1, 2020
Primary Completion
May 31, 2021
Study Completion
May 31, 2021
Last Updated
September 21, 2023
Results First Posted
September 21, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share