Investigation of New Intermittent Catheters in Healthy Volunteers
Exploratory Investigation on Performance and Safety of New Intermittent Catheters in Healthy Volunteers
1 other identifier
interventional
30
1 country
1
Brief 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.
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 Mar 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
Study Start
First participant enrolled
March 1, 2020
CompletedFirst Submitted
Initial submission to the registry
May 28, 2020
CompletedFirst Posted
Study publicly available on registry
June 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedResults Posted
Study results publicly available
July 3, 2023
CompletedJuly 3, 2023
August 1, 2022
6 months
May 28, 2020
February 4, 2022
August 8, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Post-void Residual Urine
Immediately after the procedure/catheterization, up to 15 min.
Catheterization Insertion Discomfort
Immediately after the procedure/catheterization, up to 5 min.
Catheterization Urination Discomfort
Immediately after the procedure/catheterization, up to 5 min.
Withdrawal Discomfort
Immediately after the procedure/catheterization, up to 5 min.
Overall Catheterization Discomfort
Immediately after the procedure/catheterization, up to 5 min.
- +1 more secondary outcomes
Study Arms (3)
Intermittent catheter; SpeediCath® Standard male or female
ACTIVE COMPARATORParticipants underwent catheterization with standard of care intermittent catheter. The catheterization was performed by a trained nurse.
New intermittent catheter Variant 1 for male or female
EXPERIMENTALParticipants underwent catheterization with the new intermittent catheter Variant 1 for males or females. The catheterization was performed by a trained nurse.
New intermittent catheter Variant 2 for male or female
EXPERIMENTALParticipants underwent catheterization with the new intermittent catheter Variant 2 for males or females. The catheterization was performed by a trained nurse.
Interventions
Intermittent catheterization through the urethra draining the bladder, using SpeediCath® Standard male or female.
Intermittent catheterization through the urethra draining the bladder, using the new Variant 1 for male or female.
Intermittent catheterization through the urethra draining the bladder, using the new Variant 2 for male or female.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Coloplast A/Slead
Study Sites (1)
Urologisk klinik, Afsnit 2112, Rigshospitalet
Copenhagen, Copenhagen Ø, 2100, Denmark
Related Publications (1)
Landauro MH, Tentor F, Pedersen T, Jacobsen L, Bagi P. Improved Performance With the Micro-Hole Zone Intermittent Catheter: A Combined Analysis of 3 Randomized Controlled Studies Comparing the New Catheter Technology With a Conventional Eyelet Catheter. J Wound Ostomy Continence Nurs. 2023 Nov-Dec 01;50(6):504-511. doi: 10.1097/WON.0000000000001029.
PMID: 37966080DERIVED
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
May 28, 2020
First Posted
June 24, 2020
Study Start
March 1, 2020
Primary Completion
September 1, 2020
Study Completion
September 1, 2020
Last Updated
July 3, 2023
Results First Posted
July 3, 2023
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share