An observational study in Bladder Outlet Obstruction, Multiple Sclerosis and Cauda Equina Syndrome, sponsored by ConvaTec Inc.. Completed at 16 sites in 3 countries. Open to male participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-04-30.
Sponsored by ConvaTec Inc. · Observational
Male self catherterisng observational study.
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.
42 studies on the registry are indexed under Urinary Bladder Neck Obstruction; 10 are open to participants now.
This study's enrollment of 72 is below the median of 165 across 14 observational studies indexed under Urinary Bladder Neck Obstruction.
Browse Urinary Bladder Neck Obstruction studies →ConvaTec Inc. is the lead sponsor of 46 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult males who self-catheterise
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Adult male (aged 18 years and over)
Exclusion Criteria:
Participation in another related urological study
Self-catheterising with GC Male and Glide Male with Feelclean technology
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
Time frame: 60 days
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
Time frame: 60 days
To assess compliance with the self-catheterization for the study duration
To assess compliance with the self-catheterization for the study duration
Time frame: 60 days
Plan to share: No
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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Urinary Bladder Neck Obstruction →