GentleCath™ Air for Men Intermittent Catheter With FeelClean™ Technology

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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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

Intervention / Treatment
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* Device: Intermittent self-catheterisation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Intermittent self-catheterisation|Self-catheterising with GC Air Male with Feelclean technology|

What is the study measuring?
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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 |  | 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 |  | 60 days | 
| To assess compliance with the self-catheterization for the study duration |  | 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neurogenic bladder, intermittent self-catherterisation, pain, bladder outflow obstruction