A Confirmatory Study Confirming Performance of a New Intermittent Catheter
CompletedNAResults postedLast updated 18 March 2025
What this trial tests
NA trial testing Investigational device - intermittent catheter with micro-hole zone in Urinary Retention in 73 participants. Completed in 3 January 2023.
Adults 18 to 100, male only, with Urinary Retention. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Residual Urine at 1st Flow Stop (HCP-led Catheterization) i.e., Total Catheterisation Volume Minus Volume at 1st Flow-stop, Both Derived From a Catheterisation ProfilePrimary· Immediately after the procedure/catheterization, at second and third clinic visit following 4 weeks of home catheterization
The residual urine at 1st flow-stop during catheterization (performed by a HCP) represents the volume of urine left in the bladder, the first time the urine stops running out of the catheter during bladder emptying.
Hence, the residual volume at 1st flow-stop was calculated as the total volume post catheterisation minus the volume at 1st flow-stop, derived from a catheterisation profile which was connected to a time-logged weighing \[g\].
Group
Value
95% CI
Investigational Device (Intermittent Catheter With Micro-hole Zone, CH12 or CH14)
Number of Flow-stop Episodes (HCP-led Catheterization)Primary· Immediately after catheterisation, at second and third clinic visit following 4 weeks of home catheterization
Number of flow-stop episodes were determined as instances where the flow rate decreased to less than 0.8 mL/s for a period of at least two seconds. All episodes were detected by automatic thresholding, followed by manual inspection, where the intra-catheter pressure readings were used to support the assessment of a flow stop.
Group
Value
95% CI
Investigational Device (Intermittent Catheter With Micro-hole Zone, CH12 or CH14)
Number of Flow-stop Episodes (Self-led Catheterization)Secondary· Immediately after the procedure/catheterization, at second and third clinic visit following 4 weeks of home catheterization
Number of flow-stops were measured with a pressure sensor, which is an electronic device used for monitoring the hydrostatic pressure at the outlet of an intermittent urinary catheter during emptying. From a sensor curve, flow-stops were identified by two individually trained evaluators as a hydrostatic pressure peak coinciding with a urine flow-stop/ urine dripping (flowrate lower than 0,8 ml/sec). Results from both evaluators were compared and in case of discrepancy a discussion was performed to extenuate discrepancies and agree on a final interpretation of the curves.
Group
Value
95% CI
Investigational Device (Intermittent Catheter With Micro-hole Zone, CH12 or CH14) Then Comparator
0.13
0.04 – 0.37
Comparator Device (Standard Intermittent Catheter, CH12/14) Then Investigational Device
0.96
0.65 – 1.43
Residual Urine at 1st Flow Stop (Self-led Catheterization)Secondary· Immediately after the procedure/catheterization, at second and third clinic visit following 4 weeks of home catheterization
The residual urine at 1st flow-stop during catheterization (performed by the participant self) represents the volume of urine left in the bladder, the first time the urine stops running out of the catheter during bladder emptying.
Hence, the residual volume at 1st flow-stop was calculated as the total volume post catheterisation minus the volume at 1st flow-stop, derived from a catheterisation profile which was connected to a time-logged weighing \[g\].
Group
Value
95% CI
Investigational Device (Intermittent Catheter With Micro-hole Zone, CH12 or CH14)
Mean Red Blood Cell ConcentrationSecondary· Dipstick test for haematuria was performed daily were performed in week 3 and 4 (1st home-period) and in week 7 and 8 (2nd home-period).
The average (mean) Red blood cell concentration based on a dipstick test, collected daily during the two weeks of the home test period T1 and T2 \[Erythrocytes/µL\].
Group
Value
95% CI
Investigational Device (Intermittent Catheter With Micro-hole Zone, CH12 or CH14)
Positive Hematuria Event Post-catheterisationSecondary· week 3 and 4 (1st home-period) and in week 7 and 8 (2nd home-period).
Number of positive hematuria events (i.e., blood in urine) based on a dipstick test, collected daily during the final two weeks of the home test period T1 and T2 \[positive/negative scale\]. Positive value = blood in the urine. Negative value = no blood in the urine.
Group
Value
95% CI
Investigational Device (Intermittent Catheter With Micro-hole Zone, CH12 or CH14)
Time frame: The study consisted of four study visits in a clinic (V0-V3) and two 4-week test periods at home. Hence, the total study duration for the individual subject lasted approximately nine weeks..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
A multi-centre, randomized, controlled crossover design. The total study duration for the individual subject was approximately 9 weeks. The study consisted of four study visits (V0-V3) and two 4-week test periods at home (T1 and T2). Visit 0 and 1 was performed on the same day if subjects allowed.
One population included all enrolled subjects who took part in the two test periods in a home setting only (T1 and T2). This constituted the Full Analysis Set (FAS) 1 (N=73)where only endpoints related to dipstick hematuria, catheter perception and quality of life were assessed.
A subset of subjects from the FAS1 also took part in two clinic visits (V2 and V3) where endpoints related to bladder emptying and discomfort were assessed. One visit took place in between the two test periods at home (V2) and the other visit took place after the last test period at home (V3) which was also the termination visit. This subset is termed the FAS 2 (N=49).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Coloplast A/S
Last refreshed: 18 March 2025
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