Performance of a Single-use Intermittent Micro-hole Zone Catheter

NCT05485922 | Completed Results

• 1 other identifier: CP353
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized, controlled crossover study was to assess the performance of a new micro-hole zone catheter compared to a conventional 2-eyelet catheter in 42 male intermittent catheter users. The main objective of this study was to demonstrate superiority of the micro-hole zone catheter in terms of number of flow-stop episodes and residual volume at first flow-stop, with the catheterization performed by a health care professional in a hospital setting compared to a conventional two-eyelet catheter.

Conditions

Urinary Incontinence; Retention, Urinary

Outcome Measures

Primary Outcomes (3)

• Number of Flow-stop Episodes

  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.

  Immediately after the procedure/catheterization

• 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. 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 \[g\].

  When the first flow-stop appeared, the amount of voided urine was measured.

• Number of Flow-stop Episodes

  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

Other Outcomes (2)

• Pressure Measurement at 1st Flow-stop Derived From a Catheterisation Profile.

  When the first flow-stop appeared, the pressure at the drainage holes was measured

• Post-catheterisation Volume

  Immediately after catheterisation

Study Arms (2)

Investigational device - intermittent catheter with a micro-hole zone

EXPERIMENTAL

A ready-to-use, sterile, hydrophilic-coated male catheter for intermittent catheterisation with a flexible tip and a micro-hole zone for urinary drainage in sizes CH12 and CH14. The catheterization was performed by a trained nurse.

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

Comparator device - VaPro intermittent catheter

ACTIVE COMPARATOR

Hollister VaPro, a single-use hydrophilic sleeved soft/flexible catheters in the sizes CH12 or CH14. The catheterization was performed by a trained nurse.

Device: Comparator device -VaPro intermittent catheter

Interventions

Investigational device - intermittent catheter with a micro-hole zone DEVICE

The investigational device was a urinary catheter for bladder drainage through the urethra. The product is for intermittent use.

Investigational device - intermittent catheter with a micro-hole zone

Comparator device -VaPro intermittent catheter DEVICE

The comparator device is a urinary catheter for bladder drainage through the urethra. The product is for intermittent use.

Comparator device - VaPro intermittent catheter

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The device is a male catheter
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is Male
• Is at least 18 years of age and has full legal capacity
• Has given written informed consent
• Has signed letter of authority (only DK)
• Has used clean intermittent catheterisation CH12 or CH14 for at least one month
• Use intermittent catheterisation as the primary bladder emptying method
• Is able (assessed by investigator) and willing to follow study procedures

You may not qualify if:

• Is participating in any other clinical study during this investigation
• Has previous participated in this study
• Has symptoms of urinary tract infection as judged by the investigator 4 Is an individual with history, suspected or showing signs of producing urine with excessive amount of mucus or large/clustered sediments or debris
• \. Has any known allergies towards ingredients in the investigational device

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (1)

Sanos Clinic

Gandrup, Denmark

Location

MeSH Terms

Conditions

Urinary Incontinence; Urinary Retention

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Medical Writer
• Organization: Coloplast, Clinical strategies

dkmhla@coloplast.com

+4549112057

Study Officials

• Cecilie Rovsing, MD

  Sanos

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2022
• First Posted: August 3, 2022
• Study Start: September 23, 2022
• Primary Completion: November 4, 2022
• Study Completion: November 4, 2022
• Last Updated: March 5, 2025
• Results First Posted: March 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)