GC Air Male
Research type
Research Study
Full 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
IRAS ID
315512
Contact name
Christopher Harding
Contact email
Sponsor organisation
ConvaTec Limited
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
CPMS ID, 52710
Duration of Study in the UK
0 years, 6 months, 28 days
Research summary
This is an observational study to assess the user experience after use of the Gentle Cath Air Male intermittent catheter. QoL will also be assessed at baseline D30 and D60.
The subject will be on the study for a maximum of 60 daysLay summary of study results: 72 subjects were enrolled onto the study, of these 57 (79.17%) completed the study, 14 (19.44%) withdrew from the study and 1 (1.39%) subject was lost to follow up. Of these subjects 10 have been excluded from the analysis, these subjects are from within the subject withdrawal category.
Primary Objectives
ISCQ Questionnaire responses
Subjects overall subjects either strongly agreed or slightly agreed that is was easy to prepare their catheters each time they needed it. For Gentle Cath (GC)Air there were 20% of subjects that found they slightly disagreed that it was easy to prepare their catheter, whilst for GC Glide it was even split at 44% of subjects that either found the strongly agreed it was easy to prepare or slightly disagreed it was easy to prepare. 3.8 % of subjects on GC Air strongly disagreed that it was easy to prepare their catheter for use.
Overall, 52% of subjects found they strongly agreed with the statement it is easy to insert my catheter, 47% within the UK and 61% in the United States. Of which 45% of subjects were using GC Air, 52% of subjects were using GC Glide and 59% were using a combination of the catheters. 58% of subjects had an obstructive diagnosis and 44% with a non-obstructive diagnosis. There was a smaller percentage overall at 9.6% of subjects that strongly disagreed that it was easy to insert their catheter, with the subjects using a combination being at 11%. The percentage of subject that strongly agreed increased from Day 0 marginally at Day 15 and the start of using the GentleCath Catheters.
Overall, 39% of subjects found they strongly disagreed with the statement I find inserting my catheter is uncomfortable at times, 38% being from the UK, 42% from the US and 40% from France. Of which 38% of subjects were using CG Air, 36% using GC Glide and 41% of the subject that used a combination. 27% of GC Air did slightly agree that they found inserting the catheter uncomfortable sometimes, compared with 23% of those using a combination and 16% for GC Glide. From day 0 the percentage did increase slightly for those that strongly agreed when they started using the GentleCath catheters.
Overall, 37% of subjects strongly agreed that the design of the catheter made it easier to insert, 30% being from the United Kingdom and 48% from the United States. Of which 33% were subjects using GC Air and 44% using GC Glide subjects. 47% of these subjects had an obstructive diagnosis and 25% had a non-obstructive diagnosis. There was a lower percentage of subjects that either slightly or strongly disagreed with a lower percentage falling in the GC Air group compared to the GC Glide or combined group.
Overall, 40% of subjects strongly disagreed with the statement the catheter is fiddly (difficult) to use, 35% from the United Kingdom and 51% from the United States. Of which 44% of subjects were using GC Air, 37% were combined and 32% of subjects were using GC Glide. With 45% having an obstructive diagnosis and 35% with a non-destructive diagnosis. There was a higher percentage (44%) of GC Glide subjects that did slightly agree that the catheter was fiddly (difficult) to use. There was only a small change in percentage for subjects after Day 0 and he start of the subjects using the GentleCath catheters.
Overall subjects 51% of subjects strongly disagreed with the statement lubrication on the catheter makes it difficult to use, 46% of subjects within the United Kingdom 57% of subjects within the United States and 80% within France. Of which 46% of subjects had a non-obstructive diagnosis and 56% with an obstructive diagnosis. This is broken down to 59% of subjects using GC Air, 36% of subjects using GC Glide and 45% using a combination of the two types of catheters.
43% of subjects strongly disagreed with the statement that the storage of catheters at home is inconvenient, of which 37% were within the United Kingdom, 51% within the United States and 60% within France, with 41% of subjects having a non-obstructive diagnosis and 44% having an obstructive diagnosis. 41% of subjects that strongly disagreed were using a combination of catheters, 41% were using GC Air and 56% were using GC Glide.
30% of subjects did strongly agree that their catheter was discreet the highest percentage was the subjects using GC Air at 33%, whilst the subjects that were using a combination of catheters was 31% and those that were using GC Glide was 4%. The subjects that were using GC Glide the highest percentage at 36% neither agreed nor disagreed that their catheter was discreet. 31% of subjects that had a non-obstructive diagnosis did strongly agree and 30% of subjects with an obstructive diagnosis.
33% of subjects strongly agreed that they can use their catheters discreetly when away from home, of which 34% were using GC Air, 16% were using GC Glide and 34% were using a combination of catheters.
This was followed by slightly agree at 29%. Those using GC Glide had a higher percentage of subjects at 56% which stated this. A combined 54% of subjects had a non-obstructive diagnosis either slightly or strongly agreed and a combined 69% of subjects had an obstructive diagnosis.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
22/NE/0109
Date of REC Opinion
9 Aug 2022
REC opinion
Further Information Favourable Opinion