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Completed

NCT Number: NCT05841004

Clinical Trial of New Single-use Compact Intermittent Catheter

The study is a randomised, single-blinded, controlled crossover study. The total study duration for the individual subject will be between two days - two weeks, consisting of three site visits. Visits 0 and 1 can be performed on the same day. Visit 2 can be performed the day after visit 1. For visit 1 and 2, catheterizations will be performed in a hospital setting by a health care professional for bladder emptying assessment and collection of urine samples for haematuria assessment. A sub-group of subjects (all enrolled subjects at DK sites) will be asked to conduct a self-catheterization at visit 2 after hcp catheterization and evaluate discomfort and PVR.

The total study duration for the individual subject will be up to 14 days.

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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 Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Odense Universitetshospital

Odense, 5000, Denmark

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Is Female
  • Is at least 18 years of age and has full legal capacity
  • Has signed an informed consent form
  • Has used clean intermittent self-catheterisation (CISC) (CH12 or CH14) for at least one month up to inclusion
  • Is using intermittent self-catheterisation for a minimum of 3 times per day for bladder emptying
  • Has used a compact catheter 50% of the time (or more) for the last two weeks prior to entering the study
  • Has the ability (assessed by investigator) and willingness to follow study procedures or is able to use a compact catheter assessed by investigator

Exclusion criteria

  • Is participating in any other clinical study during this investigation
  • Has previously participated in this study
  • Has symptoms of urinary tract infection at time of inclusion, as judged by the investigator (if the patient recovers within the recruitment period, a second inclusion is allowed, under a different subject id)
  • Is an individual with a history of - suspected to be - or showing signs of producing an excessive amount of mucus or large/clustered sediments or debris
  • Has any known allergies towards ingredients in the investigational device
  • Is pregnant
  • Is breastfeeding

Treatment and study plan

Investigational device

Device

Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (sizes CH12 and CH14) for urinary drainage. The investigational device is for single use.

Comparator device

Device

Hollister Infyna Chic, single-use compact catheter.

Primary outcomes

  1. Residual Volume at 1st Flow-stop (Catheterisation Performed by HCP)

    Time frame: At Visit 1 and Visit 2

    Measure residual volume at 1st flow-stop i.e., post catheterisation volume minus volume at 1st flow-stop, both derived from a catheterisation profile, [mL]

Secondary outcomes

  1. Number of Flowstops (Catheterisation Performed by a Healthcare Professional)

    Time frame: At Visit 1 and Visit 2

    Measure number of flow-stop episodes derived from a catheterisation profile (catheterisation performed by a healthcare professional), [number].

  2. Residual Volume Post Catheterisation

    Time frame: At Visit 1 and Visit 2

    Measure average residual volume post catheterisation (PVR) measured with a bladder scanner (triplicate measurements), [mL],

  3. Number of Adverse Events

    Time frame: At Visit 1 and Visit 2

    Count number of Adverse events, [number]

Other outcomes

  1. Discomfort Measure by VAS (Only in DK)

    Time frame: At Visit 1 and Visit 2

    Discomfort is measured by Visual Analogue Scale (VAS), which is measured on a 10 cm horizontal scale ranging from "no discomfort" at 0 cm to "worst possible discomfort" at 10 cm caused by the catheter, by drawing a vertical line indicating how the subject experienced the catheterization divided into the four following categories: Discomfort at insertion measured using the VAS (VAS) [cm] Discomfort at withdrawal measured using the VAS, [cm] Discomfort during emptying of bladder measured using the VAS, [cm] Discomfort at end of emptying the bladder measured using the VAS, [cm]

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Official study title

A Randomized, Crossover Study Confirming Performance of a New Single-use Compact Intermittent Catheter vs. Infyna Chic in a Pop-ulation of Adult Female Intermittent Catheter Users.

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 3, 2023
Registry last updated
Jan 23, 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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