A Confirmatory Study Confirming Performance of a New Intermittent Catheter

Not Applicable

Completed

Conditions: Urinary Retention

Interventions: Device: Investigational device - intermittent catheter with micro-hole zone
Device: Comparator - standard intermittent catheter

Registration Number: NCT05485935

Lead Sponsor: Coloplast A/S

Brief Summary: 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).

Detailed Description: This investigation was a multi-centre, randomized, controlled crossover study including 73 male clean intermittent catheterization (CIC) users.

The study consisted of four study visits (V0-V3) and two 4-week test periods at home (T1 and T2). Visit 0 and 1 were performed on the same day if participants allowed. Visit 0 included the screening-, inclusion-, and randomization phase of participants and at visit 1, participants performed a self-catheterization with the device according to their respective randomization scheme. This was followed by a dipstick test for hematuria. This constituted the Full Analysis Set (FAS) 1, consisting of 73 participants.

In the two 4-week test periods (T1 and T2, respectively) the participants catheterized at home with the specified catheter according to their randomization scheme. Both 4-week periods started with a 2-week run-in period followed by a 2-week period during which a dipstick test for hematuria was performed daily.

For Visit 2 and 3, a sub-group of participants was invited for a clinical test visit during which participants were catheterized with the same device applied during the preceding home-test period. First a healthcare professional (HCP)-led catheterization was performed followed by a self-catheterization, and endpoints related to bladder emptying (residual urine and number of urinary flow-stop episodes) were measured. After each catheterization, any residual urine left in the bladder was measured with a bladder scanner and hematuria was assessed with a dip-stick test. After the self-catheterization process, subjects at clinic visit V2 and V3 completed a questionnaire related to discomfort.This constituted the Full Analysis Set (FAS) 2, consisting of 49 participants.

All participants completed a perception questionnaire and a HRQoL questionnaire associated with the catheter during the last two weeks of the home test period. For participants not part of clinic visits V2 and V3, a nurse assisted with the questionnaires after each home-test period during a remote home visit. Thereafter, all participants were introduced to the second device to be tested for the next home-test period.

After the second home-test period, the study was terminated with a test visit 3 (V3), either in the clinic (for the subset group, FAS2) or a home visit by the nurse (the FAS1 group).

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 73

Inclusion Criteria

Male
Was at least 18 years of age and had full legal capacity
Had given written informed consent
Had signed letter of authority (only DK)
Had used clean intermittent self-catheterization (CISC) for at least the last 3 months
Had used intermittent catheterization as the only bladder emptying method for at least the last 3 months
Self-catheterized using Coloplast SpeediCath Flex or Hollister VaPro catheters, CH12 or CH14, for at least 3 months prior to inclusion
Had the ability (assessed by investigator) and willingness to adhere to a 2-month study period

Exclusion Criteria

Participation in any other clinical study during this investigation
Previous participation in the study
Symptoms of urinary tract infection as judged by the investigator (rescheduling allowed within recruitment period for LPI)
Individuals with history, suspected or showing signs of producing urine with excessive amount of mucus or large/clustered sediments or debris
Any known allergies towards ingredients in the investigational device

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Investigational device - intermittent catheter with micro-hole zone	Investigational device - intermittent catheter with micro-hole zone	Ready-to-use, sterile, hydrophilic coated intermittent male catheter (sizes CH12 and CH14) with a flexible tip and a micro-hole zone for urinary drainage. The investigational device is for single use.
Comparator device - standard intermittent catheter	Comparator - standard intermittent catheter	Single-use, hydrophilic coated intermittent male catheters (sizes CH12 and CH14) with sleeves: SpeediCath Flex, VaPro, VaPro Pocket, VaPro Plus and VaPor Plus Pocket.

Primary Outcome Measures

Name	Time	Method
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 Profile	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 \[g\].
Number of Flow-stop Episodes (HCP-led Catheterization)	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.

Secondary Outcome Measures

Name	Time	Method
Number of Flow-stop Episodes (Self-led Catheterization)	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.
Positive Hematuria Event Post-catheterisation	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.
Residual Urine at 1st Flow Stop (Self-led Catheterization)	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 \[g\].
Mean Red Blood Cell Concentration	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 \[Erythrocytes/µL\].

Trial Locations

Locations (6): Hopital Claude Huriez
🇫🇷
Lille, France
Artimed
🇩🇪
Kassel, Germany
Illingworth Research Group
🇬🇧
Macclesfield, Cheshire, United Kingdom
Sanos Clinic
🇩🇰
Gandrup, Nordjylland, Denmark
Rigshospitalet
🇩🇰
København, Denmark
Hôpital Tenon
🇫🇷
Paris, France