A Confirmatory Study Confirming Performance of a New Intermittent Catheter

NCT05485935 | Completed Results

• 1 other identifier: CP334
• Study Type: interventional
• Target: 73
• Locations: 4 countries
• Sites: 6

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).

Conditions

Urinary Retention

Outcome Measures

Primary Outcomes (2)

• 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

  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 \[g\].

  Immediately after the procedure/catheterization, at second and third clinic visit following 4 weeks of home catheterization

• Number of Flow-stop Episodes (HCP-led 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.

  Immediately after catheterisation, at second and third clinic visit following 4 weeks of home catheterization

Secondary Outcomes (4)

• 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

• 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

• 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).

• Positive Hematuria Event Post-catheterisation

  week 3 and 4 (1st home-period) and in week 7 and 8 (2nd home-period).

Study Arms (2)

Investigational device - intermittent catheter with micro-hole zone

EXPERIMENTAL

Single-use, sterile, hydrophilic coated intermittent male catheter. The external diameter is measured in millimeters (Charrière scale: Ch, CH) and the sizes available were CH12 and CH14 with a flexible tip and a micro-hole zone for urinary drainage.

Device: Investigational device - intermittent catheter with micro-hole zone

Comparator device - standard intermittent catheter

ACTIVE COMPARATOR

Single-use, sterile, hydrophilic coated intermittent male catheters (sizes CH12 and CH14) with sleeves: SpeediCath Flex, VaPro, VaPro Pocket, VaPro Plus and VaPro Plus Pocket.

Device: Comparator - standard intermittent catheter

Interventions

Investigational device - intermittent catheter with micro-hole zone DEVICE

Intermittent male catheter with micro-hole zone for urinary drainage

Investigational device - intermittent catheter with micro-hole zone

Comparator - standard intermittent catheter DEVICE

SpeediCath Flex, VaPro Pocket, VaPro Plus and VaPro Plus Pocket.

Comparator device - standard intermittent catheter

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: Male users of intermittent urinary catheterizations to empty their bladder.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Had the ability (assessed by investigator) and willingness to adhere to a 2-month study period

You may not qualify if:

• 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

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (6)

Sanos Clinic

Gandrup, North Denmark, 9362, Denmark

Location

Rigshospitalet

Copenhagen, Denmark

Location

Hopital Claude Huriez

Lille, 59037, France

Location

Hôpital Tenon

Paris, 75020, France

Location

Artimed

Kassel, Germany

Location

Illingworth Research Group

Macclesfield, Cheshire, SK10 2XR, United Kingdom

Location

MeSH Terms

Conditions

Urinary Retention

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Malene Hornbak Landauro, Medical writer of Clinical strategies
• Organization: Coloplast A/S

dkmhla@coloplast.com

+4549112057

Study Officials

• Nikesh thiruchelvam, Dr

  NHS Foundation Trust

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This was a multi-centre, randomized, controlled crossover design. The total study duration for the individual participant 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).

Study Record Dates

• First Submitted: June 30, 2022
• First Posted: August 3, 2022
• Study Start: August 20, 2022
• Primary Completion: January 3, 2023
• Study Completion: January 3, 2023
• Last Updated: March 18, 2025
• Results First Posted: March 18, 2025

Record last verified: 2025-02

Locations

DK (2); GB (1); FR (2); DE (1)