GentleCath™ for Men Intermittent Catheter With FeelClean™ Technology

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05470751
• Other study ID #: CC-21-425
• Status: Completed
• Start date: February 2, 2023
• Est. completion date: April 6, 2024

Study information

• Verified date: April 2024
• Source: ConvaTec Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Male self catherterisng observational 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: April 6, 2024
• Est. primary completion date: April 6, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Bladder Outlet Obstruction
• Cauda Equina Syndrome
• Detrusor Underactivity
• Enlarged Prostate With Lower Urinary Tract Symptoms
• Hypokinesia
• Lower Urinary Tract Symptoms
• Multiple Sclerosis
• Parkinson Disease
• Spinal Cord Injuries
• Urinary Bladder Neck Obstruction
• Urinary Bladder, Underactive

Intervention

Device:
• Intermittent self-catheterisation
Self-catheterising with GC Male and Glide Male with Feelclean technology

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Bordeaux | Pellegrin Hospital - Urology Department	Bordeaux
France	Assistance Publique Hopitaux de Paris | Pitie Salpetriere University Hospital - Urology Department	Paris
United Kingdom	North Bristol NHS Trust | Southmead Hospital - Research and Development - Urology Department	Bristol	Westbury-on-Trym
United Kingdom	Kent and Canterbury Hospital | Renal Research Delivery Team	Canterbury	Kent
United Kingdom	Broomfield Hospital	Chelmsford	Essex
United Kingdom	Guy's and St Thomas' Foundation Trust | Guy's Hospital - Transplant, Renal and Urology Research	London
United Kingdom	King's College Hospital NHS Foundation Trust | King's College Hospital - Renal Research Department	London
United Kingdom	Newcastle upon Tyne Hospitals NHS Foundation Trust | Freeman Hospital - Urology Department	Newcastle	Newcastle Upon Tyne
United Kingdom	Aneurin Bevan University Health Board | Royal Gwent Hospital - Clinical Research Centre	Newport	Gwent
United Kingdom	Southampton General Hospital	Southampton	Hampshire
United Kingdom	Mid and South Essex NHS Foundation Trust | Southend University Hospital - Research & Development	Southend-on-Sea	Essex
United Kingdom	Stockport NHS Foundation Trust | Stepping Hill Hospital - Research and Innovation Department	Stockport	Cheshire
United Kingdom	Sunderland Royal Hospital	Sunderland	Tyne & Wear
United Kingdom	Mid Yorkshire Teaching NHS Trust | Pinderfields Hospital - Yorkshire Regional Spinal Injuries Centre	Wakefield	Yorkshire
United States	Trustees of The University of Pennsylvania | Penn Urology Washington Square	Philadelphia	Pennsylvania
United States	Kessler Institute for Rehabilitation	West Orange	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
ConvaTec Inc.

Countries where clinical trial is conducted

United States,  France,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess difficulty during catheterisation and quality of life using the ICDQ and ISC-Q validated questionnaires during catheterisation	To assess difficulty during catheterisation and quality of life using the ICDQ and ISC-Q	60 days
Secondary	To assess patient confidence regarding reduced stickiness plus related risk of urethral injury and resultant bleeding or infection	To assess patient confidence regarding reduced stickiness plus related risk of urethral	60 days
Secondary	To assess compliance with the self-catheterization for the study duration	To assess compliance with the self-catheterization for the study duration	60 days