N/A
N=22
Investigation of New Intermittent Catheter Swelling Media in Healthy Volunteers
Catheter Site Pain · Catheter Site Discomfort
Bottom Line
View on ClinicalTrials.gov: NCT04633291 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcome: Primary: Overall Discomfort During Nurse Catheterization — 1.75; 1.79 cm — p=0.88
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Novel swelling media (Device); Comparator swelling media (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Coloplast A/S
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Discomfort During Nurse Catheterization |
1.75; 1.79 | 0.88 |
| SECONDARY Insertion Discomfort During Nurse Catheterization |
2.17; 2.03 | 0.62 |
| SECONDARY Withdrawal Discomfort During Nurse Catheterization |
1.16; 1.27 | 0.63 |
| SECONDARY Urination Discomfort After Catheterization |
0.52; 0.37 | 0.19 |
| SECONDARY Catheter Handling During Insertion |
8; 6; 7; 8; 4; 3 | 0.381 |
| SECONDARY Catheter Handling During Withdrawal |
17; 13; 4; 8; 0; 0 | 0.541 |
| SECONDARY Touch of Catheter Coating |
4; 3; 18; 19 | 0.269 |
| SECONDARY Visual Blood During Catheterization |
1; 1; 21; 21 | 1.0 |
| SECONDARY Microscopic Blood in Catheter-collected Urine |
6; 6; 16; 16 | 1.0 |
Summary
Investigation of novel swelling media for CE marked intermittent urinary catheters. The study was a randomized, single blinded, cross-over investigation comparing a novel swelling media with a comparator swelling media in 22 adult, healthy, male volunteers.
Eligibility Criteria
Inclusion Criteria
- Written informed consent given
- Minimum 18 years of age and with full legal capacity
- Male gender
- Willing to refrain from using analgesics up to 24 hours prior to catheterization visits
- Negative urine multistix analysis for erythrocytes (microscopic hematuria)
- Negative urine multistix analysis for leukocytes and nitrite, or if positive, subsequent negative for bacterial growth in urine culture
Exclusion Criteria
- Abnormalities, diseases or surgical procedures performed in the lower urinary tract
- Symptoms of urinary tract infections (at least one of the following: frequent urination, stinging or pain at urination)
- Participating in other clinical investigations related to urinary tracts system during this investigation (inclusion to termination) or previously participation in this investigation
- Known hypersensitivity toward any of the investigational device
Data sourced from ClinicalTrials.gov (NCT04633291). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.