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Completed

NCT Number: NCT05814211

Clinical Trial of New Intermittent Single-use Catheter

A multi-centre, open-labelled, randomised, crossover design. The total study duration for the individual subject will be approximately 4 weeks, consisting of four site visits and two 2-week test periods at home. Visits 0 and 1 can be performed on the same day. For visit 2 and 3, 2 catheterisations will be performed in a hospital setting (one HCP catheterisation and one self-catheterisation) for bladder emptying and user experience assessments. Visit 1 and 2 are followed by a home-use test period, followed by visit 3 which terminates the study.

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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

Rigshopsitalet, Copenhagen, København Ø, Denmark

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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

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 - newly developed intermittent catheter

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 #1 - SpeediCath Eve

Device

During comparator study period, subjects will only receive one of the comparator products. Randomization will decide which one.

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

Comparator device #2 - SpeediCath Compact Plus Female

Device

During comparator study period, subjects will only receive one of the comparator products. Randomization will decide which one.

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

Primary outcomes

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

    Time frame: Tested at site visit after 14 days of device home use.

    Residual volume at 1st flow-stop i.e., post catheterisation volume minus volume at 1st flow-stop, both derived from a catheterisation profile (catheterisation performed by a healthcare professional)

Secondary outcomes

  1. Number of Flow-stops (Catheterisation Profile, Catheterisation Performed by HCP)

    Time frame: Tested at site visit after 14 days of device home use.

    Number of flow-stop episodes derived from a catheterisation profile (catheterisation performed by a healthcare professional)

  2. Number of Flow-stops (Catheterisation Profile, Self-catheterisation)

    Time frame: Tested at site visit after 14 days of device home use.

    Number of flow-stop episodes derived from a catheterisation profile (self-catheterisation)

  3. Residual Volume at 1st Flow-stop

    Time frame: Tested at site visit after 14 days of device home use.

    Residual volume at 1st flow-stop i.e., post catheterisation volume minus volume at 1st flow-stop, both derived from a catheterisation profile (self-catheterisation)

  4. Average Residual Volume Post Catheterisation (Bladder Scan)

    Time frame: Tested at site visit after 14 days of device home use.

    Average residual volume post catheterisation measured with the BladderScanner (triplicate measurements)

  5. Number of Adverse Events

    Time frame: From Week 0-4

    Number of Adverse events (number)

Other outcomes

  1. Exploratory: Perception Questionnaire, Handling

    Time frame: Tested at site visit after 14 days of device home use.

    Perception questions evaluated on a 5-point scale assessed on V2 and V3 (perception questionnaire). Perception questionary based on perception of catheterisations in test period leading up to the visit

  2. Exploratory: Perception Questionnaire, Confidence, Sensation, Satisfaction

    Time frame: Tested at site visit after 14 days of device home use.

    Perception questions evaluated on a 5-point scale assessed on V2 and V3 (perception questionnaire). Perception questionary based on perception of catheterisations in test period leading up to the visit

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Official study title

A Randomized, Open-labelled, Crossover Study Confirming Performance of a New Single-use Compact Intermittent Catheter in a Population of Adult Female Intermittent Catheter Users

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 14, 2023
Registry last updated
Feb 20, 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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