GentleCath™ for Men Intermittent Catheter With FeelClean™ Technology

Last updated: April 29, 2024
Sponsor: ConvaTec Inc.
Overall Status: Completed

Phase

N/A

Condition

Multiple Sclerosis

Spinal Cord Injuries

Memory Loss

Treatment

Intermittent self-catheterisation

Clinical Study ID

NCT05470751
CC-21-425
  • Ages 18-100
  • Male

Study Summary

Male self catherterisng observational study.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • • Adult male (aged 18 years and over)
  • Diagnosed with a neurological lower urinary tract dysfunction due to eitherspinal cord injury, Multiple Sclerosis, Parkinson's Syndrome, Cauda equinasyndrome Or Diagnosed with bladder outflow obstruction secondary to benignprostate enlargement Or Diagnosed with detrusor underactivity
  • Performing single use clean intermittent self-catheterisation (ISC) at leasttwice 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 orFrench
  • Sufficient dexterity to use GentleCath™ Air for Men intermittent includingability to open packaging
  • Intact urethral sensation of catheterisation
  • Willing to use only the GentleCath™ Air intermittent catheter for the fullduration of the study (60-days)
  • Subject has a valid email address so the Investigator can send links to studyquestionnaires and the subject has access to a web enabled device

Exclusion

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 orpackaging
  • Suffering from a symptomatic UTI (Urinary Tract Infections) at the time ofinclusion or in the preceding 6-weeks
  • Undergoing surgical treatment during the period of the study
  • Performing catheterisation for urethral stricture

Study Design

Total Participants: 72
Treatment Group(s): 1
Primary Treatment: Intermittent self-catheterisation
Phase:
Study Start date:
February 02, 2023
Estimated Completion Date:
April 06, 2024

Study 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.

Connect with a study center

  • Centre Hospitalier Universitaire de Bordeaux | Pellegrin Hospital - Urology Department

    Bordeaux, 33076
    France

    Site Not Available

  • Assistance Publique Hopitaux de Paris | Pitie Salpetriere University Hospital - Urology Department

    Paris, 75013
    France

    Site Not Available

  • Stockport NHS Foundation Trust | Stepping Hill Hospital - Research and Innovation Department

    Stockport, Cheshire SK2 7JE
    United Kingdom

    Site Not Available

  • Broomfield Hospital

    Chelmsford, Essex CM1 7ET
    United Kingdom

    Site Not Available

  • Mid and South Essex NHS Foundation Trust | Southend University Hospital - Research & Development

    Southend-on-Sea, Essex SS0 0RY
    United Kingdom

    Site Not Available

  • Aneurin Bevan University Health Board | Royal Gwent Hospital - Clinical Research Centre

    Newport, Gwent NP20 2UB
    United Kingdom

    Site Not Available

  • Southampton General Hospital

    Southampton, Hampshire SO16 6YD
    United Kingdom

    Site Not Available

  • Kent and Canterbury Hospital | Renal Research Delivery Team

    Canterbury, Kent CT2 7FG
    United Kingdom

    Site Not Available

  • Newcastle upon Tyne Hospitals NHS Foundation Trust | Freeman Hospital - Urology Department

    Newcastle, Newcastle Upon Tyne NE7 7DN
    United Kingdom

    Site Not Available

  • Sunderland Royal Hospital

    Sunderland, Tyne & Wear SR4 7TP
    United Kingdom

    Site Not Available

  • North Bristol NHS Trust | Southmead Hospital - Research and Development - Urology Department

    Bristol, Westbury-on-Trym BS10 5NB
    United Kingdom

    Site Not Available

  • Mid Yorkshire Teaching NHS Trust | Pinderfields Hospital - Yorkshire Regional Spinal Injuries Centre

    Wakefield, Yorkshire WF1 4DG
    United Kingdom

    Site Not Available

  • Guy's and St Thomas' Foundation Trust | Guy's Hospital - Transplant, Renal and Urology Research

    London, SE1 9RT
    United Kingdom

    Site Not Available

  • King's College Hospital NHS Foundation Trust | King's College Hospital - Renal Research Department

    London, SE5 9RS
    United Kingdom

    Site Not Available

  • Kessler Institute for Rehabilitation

    West Orange, New Jersey 07052
    United States

    Site Not Available

  • Trustees of The University of Pennsylvania | Penn Urology Washington Square

    Philadelphia, Pennsylvania 19106
    United States

    Site Not Available

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