GentleCath™ Air for Men Intermittent Catheter With FeelClean™ Technology

Sponsor

ConvaTec Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05470751

Collaborator

(none)

165

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Bladder Outlet Obstruction Multiple Sclerosis Cauda Equina Syndrome Enlarged Prostate With Lower Urinary Tract Symptoms Parkinson Disease Lower Urinary Tract Symptoms Detrusor Underactivity Spinal Cord Injuries	Device: Intermittent self-catheterisation

Study Design

Study Type:

Observational

Anticipated Enrollment :

165 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Feb 1, 2023

Anticipated Study Completion Date :

May 1, 2023

Outcome Measures

Primary Outcome Measures

To assess difficulty during catheterisation and quality of life using the ICDQ and ISC-Q validated questionnaires during catheterisation [60 days]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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