Trials / Completed
CompletedNCT05470751
GentleCath™ for Men Intermittent Catheter With FeelClean™ Technology
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
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 72 (actual)
- Sponsor
- ConvaTec Inc. · Industry
- Sex
- Male
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- 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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Intermittent self-catheterisation | Self-catheterising with GC Male and Glide Male with Feelclean technology |
Timeline
- Start date
- 2023-02-02
- Primary completion
- 2024-04-06
- Completion
- 2024-04-06
- First posted
- 2022-07-22
- Last updated
- 2024-04-30
Locations
16 sites across 3 countries: United States, France, United Kingdom
Source: ClinicalTrials.gov record NCT05470751. Inclusion in this directory is not an endorsement.