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Completed

NCT Number: NCT05485922

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Sanos Clinic

Gandrup, Denmark

About this study

The investigation was a single-centre, randomized, controlled crossover study including 42 male participants comparing the performance of two intermittent catheters (IC).

The study included an information visit (visit 0) and two test visits (visit 1 and 2) in which one catheterization with either the investigational device or the comparator device, according to a randomization scheme, was performed by a health care professional in a hospital setting assessing flow stop episodes, bladder emptying and hematuria. There were 4-14 days between each test visit (visit 1 and 2) and visit 0 and 1 could be held on the same day.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. Number of Flow-stop Episodes

    Time frame: Immediately after the procedure/catheterization

    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.

  2. Residual Urine at 1st Flow-stop

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

    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].

  3. Number of Flow-stop Episodes

    Time frame: Immediately after catheterisation

    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.

Other outcomes

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

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

    The intra-catheter pressure at the drainage holes, measured at 1st flow stop, was identified from a sensor curve.

  2. Post-catheterisation Volume

    Time frame: Immediately after catheterisation

    Post-catheterisation volume measured with a bladder Scanner assessed by the average of 3 consecutive measurements [mL]

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Official study title

A Randomized, Open-labelled, Crossover Study Confirming Performance of a Single-use Intermittent Micro-hole Zone Catheter in a Population of Adult Male Intermittent Catheter Users

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 3, 2022
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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