GentleCath™ for Men Intermittent Catheter With FeelClean™ Technology

April 29, 2024 updated by: ConvaTec Inc.

A Multi-centre Prospective Observational Study of the User Experience of Catheterisation and Quality of Life in Patients Prescribed GentleCath™ for Men Intermittent Catheter With FeelClean™ Technology

Male self catherterisng observational study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a multicentre, prospective international observational study. Male patients in the UK, USA and France performing self-catheterisation will be asked to participate in this study. The subjects will be asked to use the GentleCath™ Intermittent Catheter with FeelClean™ Technology as per their normal routine. They will be asked to record when and where they catheterise. At the baseline, during and on completion of the study, the subjects will be asked to complete Difficulty in Catheterisation plus Intermittent Catheter related Quality of Life Questionnaires.

Difficulty during catheterisation and quality of life will be assessed using the ICDQ and ISC-Q validated questionnaires during catheterisation at the start of the study before use of GentleCath™ Air has commenced (D0) and on day 1 (D1), day 15 (D15), day 30 (D30), day 45 (D45) and day 60 (D60) transcribed in a collecting record provided for this purpose. Compliance and catheter use will also be assessed.

Patient confidence regarding reduced stickiness plus related risk of urethral injury and resultant bleeding or infection will also be recorded.

Study Type

Observational

Enrollment (Actual)

72

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33076
        • Centre Hospitalier Universitaire de Bordeaux | Pellegrin Hospital - Urology Department
      • Paris, France, 75013
        • Assistance Publique Hopitaux de Paris | Pitie Salpetriere University Hospital - Urology Department
  • United Kingdom
      • London, United Kingdom, SE1 9RT
        • Guy's and St Thomas' Foundation Trust | Guy's Hospital - Transplant, Renal and Urology Research
      • London, United Kingdom, SE5 9RS
        • King's College Hospital NHS Foundation Trust | King's College Hospital - Renal Research Department
    • Cheshire
      • Stockport, Cheshire, United Kingdom, SK2 7JE
        • Stockport NHS Foundation Trust | Stepping Hill Hospital - Research and Innovation Department
    • Essex
      • Chelmsford, Essex, United Kingdom, CM1 7ET
        • Broomfield Hospital
      • Southend-on-Sea, Essex, United Kingdom, SS0 0RY
        • Mid and South Essex NHS Foundation Trust | Southend University Hospital - Research & Development
    • Gwent
      • Newport, Gwent, United Kingdom, NP20 2UB
        • Aneurin Bevan University Health Board | Royal Gwent Hospital - Clinical Research Centre
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO16 6YD
        • Southampton General Hospital
    • Kent
      • Canterbury, Kent, United Kingdom, CT2 7FG
        • Kent and Canterbury Hospital | Renal Research Delivery Team
    • Newcastle Upon Tyne
      • Newcastle, Newcastle Upon Tyne, United Kingdom, NE7 7DN
        • Newcastle upon Tyne Hospitals NHS Foundation Trust | Freeman Hospital - Urology Department
    • Tyne & Wear
      • Sunderland, Tyne & Wear, United Kingdom, SR4 7TP
        • Sunderland Royal Hospital
    • Westbury-on-Trym
      • Bristol, Westbury-on-Trym, United Kingdom, BS10 5NB
        • North Bristol NHS Trust | Southmead Hospital - Research and Development - Urology Department
    • Yorkshire
      • Wakefield, Yorkshire, United Kingdom, WF1 4DG
        • Mid Yorkshire Teaching NHS Trust | Pinderfields Hospital - Yorkshire Regional Spinal Injuries Centre
  • United States
    • New Jersey
      • West Orange, New Jersey, United States, 07052
        • Kessler Institute for Rehabilitation
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19106
        • Trustees of The University of Pennsylvania | Penn Urology Washington Square

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult males who self-catheterise

Description

Inclusion Criteria:

  • • Adult male (aged 18 years and over)

    • Diagnosed with a neurological lower urinary tract dysfunction due to either spinal cord injury, Multiple Sclerosis, Parkinson's Syndrome, Cauda equina syndrome Or Diagnosed with bladder outflow obstruction secondary to benign prostate enlargement Or Diagnosed with detrusor underactivity
    • Performing single use clean intermittent self-catheterisation (ISC) at least twice a day
    • Willing to undergo training with GC Trainer video prior to use of catheter
    • Provided fully informed consent and has sufficient understanding of English or French
    • Sufficient dexterity to use GentleCath™ Air for Men intermittent including ability to open packaging
    • Intact urethral sensation of catheterisation
    • Willing to use only the GentleCath™ Air intermittent catheter for the full duration of the study (60-days)
    • Subject has a valid email address so the Investigator can send links to study questionnaires and the subject has access to a web enabled device

Exclusion Criteria:

  • • Participation in another related urological study

    • Unable to perform ISC unaided
    • Already prescribed the GentleCath™ Air Intermittent Catheter
    • Absent urethral or perineal sensation
    • Unwilling to undergo training with GC Trainer prior to use of catheter
    • Insufficient dexterity to use GentleCath™ Air Intermittent Catheter and or packaging
    • Suffering from a symptomatic UTI (Urinary Tract Infections) at the time of inclusion or in the preceding 6-weeks
    • Undergoing surgical treatment during the period of the study
    • Performing catheterisation for urethral stricture

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess difficulty during catheterisation and quality of life using the ICDQ and ISC-Q validated questionnaires during catheterisation
Time Frame: 60 days
To assess difficulty during catheterisation and quality of life using the ICDQ and ISC-Q
60 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess patient confidence regarding reduced stickiness plus related risk of urethral injury and resultant bleeding or infection
Time Frame: 60 days
To assess patient confidence regarding reduced stickiness plus related risk of urethral
60 days
To assess compliance with the self-catheterization for the study duration
Time Frame: 60 days
To assess compliance with the self-catheterization for the study duration
60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ConvaTec Inc.

Investigators

  • Principal Investigator: Chris Harding, Site Investigator - Newcastle

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2023

Primary Completion (Actual)

April 6, 2024

Study Completion (Actual)

April 6, 2024

Study Registration Dates

First Submitted

July 20, 2022

First Submitted That Met QC Criteria

July 20, 2022

First Posted (Actual)

July 22, 2022

Study Record Updates

Last Update Posted (Actual)

April 30, 2024

Last Update Submitted That Met QC Criteria

April 29, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CC-21-425

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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