GentleCath™ for Men Intermittent Catheter With FeelClean™ Technology

Completed

• Conditions: Multiple Sclerosis; Bladder Outlet Obstruction; Spinal Cord Injuries; Cauda Equina Syndrome; Detrusor Underactivity; Enlarged Prostate With Lower Urinary Tract Symptoms; Parkinson Disease; Lower Urinary Tract Symptoms

• Registration Number: NCT05470751
• Lead Sponsor: ConvaTec Inc.

Brief Summary

Male self catherterisng observational study.

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 Timeline

• Study First Submitted: 2022-07-20
• Study First Submitted QC: 2022-07-20
• Study First Posted: 2022-07-22
• Study Start: 2023-02-02
• Status Verified: 2024-04
• Primary Completion: 2024-04-06
• Study Completion: 2024-04-06
• Last Update Submitted: 2024-04-29
• Last Update Posted: 2024-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 72

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess difficulty during catheterisation and quality of life using the ICDQ and ISC-Q validated questionnaires during catheterisation	60 days	To assess difficulty during catheterisation and quality of life using the ICDQ and ISC-Q

Secondary Outcome Measures

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

Trial Locations

Locations (16)

Stockport NHS Foundation Trust | Stepping Hill Hospital - Research and Innovation Department; 🇬🇧 Stockport, Cheshire, United Kingdom

Sunderland Royal Hospital; 🇬🇧 Sunderland, Tyne & Wear, United Kingdom

Centre Hospitalier Universitaire de Bordeaux | Pellegrin Hospital - Urology Department; 🇫🇷 Bordeaux, France

Guy's and St Thomas' Foundation Trust | Guy's Hospital - Transplant, Renal and Urology Research; 🇬🇧 London, United Kingdom

Trustees of The University of Pennsylvania | Penn Urology Washington Square; 🇺🇸 Philadelphia, Pennsylvania, United States

Aneurin Bevan University Health Board | Royal Gwent Hospital - Clinical Research Centre; 🇬🇧 Newport, Gwent, United Kingdom

Kessler Institute for Rehabilitation; 🇺🇸 West Orange, New Jersey, United States

North Bristol NHS Trust | Southmead Hospital - Research and Development - Urology Department; 🇬🇧 Bristol, Westbury-on-Trym, United Kingdom

King's College Hospital NHS Foundation Trust | King's College Hospital - Renal Research Department; 🇬🇧 London, United Kingdom

Mid Yorkshire Teaching NHS Trust | Pinderfields Hospital - Yorkshire Regional Spinal Injuries Centre; 🇬🇧 Wakefield, Yorkshire, United Kingdom

Newcastle upon Tyne Hospitals NHS Foundation Trust | Freeman Hospital - Urology Department; 🇬🇧 Newcastle, Newcastle Upon Tyne, United Kingdom

Broomfield Hospital; 🇬🇧 Chelmsford, Essex, United Kingdom

Mid and South Essex NHS Foundation Trust | Southend University Hospital - Research & Development; 🇬🇧 Southend-on-Sea, Essex, United Kingdom

Kent and Canterbury Hospital | Renal Research Delivery Team; 🇬🇧 Canterbury, Kent, United Kingdom

Assistance Publique Hopitaux de Paris | Pitie Salpetriere University Hospital - Urology Department; 🇫🇷 Paris, France

Southampton General Hospital; 🇬🇧 Southampton, Hampshire, United Kingdom