Urostomy
Conditions
Keywords
urostomy, 1-piece, cross-over, randomised, preference
Brief summary
Background Urostomy is a surgical procedure that detours or diverts urine away form a diseased or defective bladder. The bladder can be removed and the urine is passed out of the body through an opening (stoma) in the stomach. People with urostomy will not be able to start and stop urine coming out through the stoma, so a urostomy bag will be fitted to collect the urine as it comes out. A urostomy bag consists of an adhesive, which is attached to the skin around the stoma and a bag connected to the adhesive to collect the urine. It is very important the standard is high on these products; otherwise the user (urostomy-patient) will experience lots of problems with the skin around the stoma.
Detailed description
In this trial we are comparing two types of urostomy bags - the SenSura 1-piece and Hollisters Moderma Flex. Both products are CE-marked, meaning that they are safe and approved in use for people with an urostomy. Population 30 urostomy operated people from UK will participate in the trial. Only participants who normally use a flat 1-piece urostomy bag can participate. It is very important that the participants keep their normal use- and change pattern. Furthermore they need to be over 18 years old, have had the urostomy for more than 3 months, the size of the urostomy shall be between 15-55 mm, otherwise the bag will not fit them and then they should be able to handle the bags themselves and be willing to use the two products tested in the trial.
Interventions
DEVICESenSura Uro
The test product is a CE-marked non-sterile one-piece urostomy multi-chamber bag with the SenSura adhesive.
DEVICEHollister
The comparator product is CE-marked and non-sterile and produced for urostomy operated. It is a flat one-piece urostomy product, Hollister Moderma Flex Urostomy beige, Cut-to-Fit Bag, flat adhesive.
Sponsors
Coloplast A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
In order to be enrolled in the clinical investigation, the subject must: * Be at least 18 years old, * Be mentally and physically capable of signing the written consent form * Be able to fill in the Case Report Form (questionnaire) * Have an urostomy with a size between 15-55 mm. * Have had the urostomy for 3 months or more, * Use a 1-piece bag normally. * Be able to handle the bag themselves (application and removal) * Be willing to use Coloplast SenSura 1-piece bag * Be willing to use Hollisters Moderma Flex, 1-piece bag
Exclusion criteria
In order to be enrolled in the clinical investigation, the subjects must not: * Be a convex base plate user (i.e. a bowl-shaped adhesive which pushes the stoma forward) * Need to use an ostomy belt * Be currently suffering from any dermatologiacal problems, needing special treatment, in the peristomal area (investigator will evaluate skin according to a newly developed ostomy skin tool from Coloplast A/S) * Being treated with chemo- or radiation therapy, * Be hospitalized during study enrollment, or have a hospitalization or significant surgery planned during the 4-week study period, or * Be pregnant or breast-feeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Preference of Sensura vs Moderma | 4 weeks | Subjects were asked which of the tested products they preferred; SenSura or Moderma. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Removal of the Bag | 4 weeks | How easy/difficult it was to remove the bag |
| Adhesion of the Bag During Use | 4 weeks | Evaluation of the adhesion of the base plate around the stoma during use |
| Adhesives Ability to Absorb Perspiration | 4 weeks | Evaluation of the adhesives ability to absorb perspiration from the skin |
| Flexibility of the Product | 4 weeks | Evaluation of the ability of the bag to conform with the patients movements (flexibility) |
| Awareness of the Presence of the Product | 4 weeks | Evaluates the patients awareness of the presence of the product during use. |
| Immediate Adhesion | 4 weeks | Evaluation of immediate adhesion after each period |
| Feeling of Security During the Night | 4 weeks | The patients feeling of security with the product during the night |
| Problems With Splashing Sounds During Use | 4 weeks | The patient was asked whether he/she noticed any splashinh sounds during use |
| Bag Twisting During Night | 4 weeks | The patient was asked if he/she noticed whether the bag twisted during night |
| Changes in Skin Compared to Before Study | 4 weeks | The patient was asked whether he/she experienced changes in the skin condition after testing the blue/red product |
| Feeling of Security During the Day | 4 weeks | The patients feeling of security with the bag during the day |
Countries
United Kingdom
Participant flow
Recruitment details
Subjects where recruited by 6 stoma care sites in UK
Pre-assignment details
No pre-assignment details
Participants by arm
| Arm | Count |
|---|---|
| Entire Study Population Includes groups randomized to receive SenSura Uro first and Hollister Uro first | 27 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 | Herpes Zoster | 0 | 1 |
| Period 1 | Hip operation | 0 | 1 |
| Period 1 | Lack of Efficacy | 1 | 2 |
| Period 1 | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | Entire Study Population |
|---|---|
| Age, Continuous | 61.6 years STANDARD_DEVIATION 11.5 |
| Region of Enrollment United Kingdom | 27 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 16 | 0 / 11 |
| serious Total, serious adverse events | 0 / 16 | 0 / 11 |
Outcome results
Primary
Preference of Sensura vs Moderma
Subjects were asked which of the tested products they preferred; SenSura or Moderma.
Time frame: 4 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SenSura Uro | Preference of Sensura vs Moderma | 45 percentage of prefering the product |
| Hollister Uro | Preference of Sensura vs Moderma | 43 percentage of prefering the product |
Secondary
Adhesion of the Bag During Use
Evaluation of the adhesion of the base plate around the stoma during use
Time frame: 4 weeks
Population: ITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SenSura Uro | Adhesion of the Bag During Use | Poor | 5 Participants |
| SenSura Uro | Adhesion of the Bag During Use | Good | 3 Participants |
| SenSura Uro | Adhesion of the Bag During Use | Reasonable | 7 Participants |
| SenSura Uro | Adhesion of the Bag During Use | Very good | 5 Participants |
| SenSura Uro | Adhesion of the Bag During Use | Very poor | 2 Participants |
| Hollister Uro | Adhesion of the Bag During Use | Very good | 4 Participants |
| Hollister Uro | Adhesion of the Bag During Use | Very poor | 3 Participants |
| Hollister Uro | Adhesion of the Bag During Use | Poor | 5 Participants |
| Hollister Uro | Adhesion of the Bag During Use | Reasonable | 5 Participants |
| Hollister Uro | Adhesion of the Bag During Use | Good | 6 Participants |
p-value: 0.92Regression, Logistic
Secondary
Adhesives Ability to Absorb Perspiration
Evaluation of the adhesives ability to absorb perspiration from the skin
Time frame: 4 weeks
Population: ITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SenSura Uro | Adhesives Ability to Absorb Perspiration | Poor | 2 Participants |
| SenSura Uro | Adhesives Ability to Absorb Perspiration | Good | 6 Participants |
| SenSura Uro | Adhesives Ability to Absorb Perspiration | Reasonable | 8 Participants |
| SenSura Uro | Adhesives Ability to Absorb Perspiration | Very good | 4 Participants |
| SenSura Uro | Adhesives Ability to Absorb Perspiration | Very poor | 1 Participants |
| Hollister Uro | Adhesives Ability to Absorb Perspiration | Very good | 2 Participants |
| Hollister Uro | Adhesives Ability to Absorb Perspiration | Very poor | 0 Participants |
| Hollister Uro | Adhesives Ability to Absorb Perspiration | Poor | 4 Participants |
| Hollister Uro | Adhesives Ability to Absorb Perspiration | Reasonable | 7 Participants |
| Hollister Uro | Adhesives Ability to Absorb Perspiration | Good | 9 Participants |
Secondary
Awareness of the Presence of the Product
Evaluates the patients awareness of the presence of the product during use.
Time frame: 4 weeks
Population: ITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SenSura Uro | Awareness of the Presence of the Product | Much | 1 Participants |
| SenSura Uro | Awareness of the Presence of the Product | A little | 11 Participants |
| SenSura Uro | Awareness of the Presence of the Product | Some | 8 Participants |
| SenSura Uro | Awareness of the Presence of the Product | Not at all | 2 Participants |
| SenSura Uro | Awareness of the Presence of the Product | Very much | 0 Participants |
| Hollister Uro | Awareness of the Presence of the Product | Not at all | 3 Participants |
| Hollister Uro | Awareness of the Presence of the Product | Very much | 2 Participants |
| Hollister Uro | Awareness of the Presence of the Product | Much | 3 Participants |
| Hollister Uro | Awareness of the Presence of the Product | Some | 5 Participants |
| Hollister Uro | Awareness of the Presence of the Product | A little | 10 Participants |
p-value: 0.64Regression, Logistic
Secondary
Bag Twisting During Night
The patient was asked if he/she noticed whether the bag twisted during night
Time frame: 4 weeks
Population: ITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SenSura Uro | Bag Twisting During Night | Yes | 4 Participants |
| SenSura Uro | Bag Twisting During Night | No | 18 Participants |
| Hollister Uro | Bag Twisting During Night | Yes | 13 Participants |
| Hollister Uro | Bag Twisting During Night | No | 10 Participants |
Secondary
Changes in Skin Compared to Before Study
The patient was asked whether he/she experienced changes in the skin condition after testing the blue/red product
Time frame: 4 weeks
Population: ITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SenSura Uro | Changes in Skin Compared to Before Study | No, it is the same | 17 Participants |
| SenSura Uro | Changes in Skin Compared to Before Study | Yes, it is better | 0 Participants |
| SenSura Uro | Changes in Skin Compared to Before Study | Yes, it is worse | 4 Participants |
| Hollister Uro | Changes in Skin Compared to Before Study | No, it is the same | 19 Participants |
| Hollister Uro | Changes in Skin Compared to Before Study | Yes, it is better | 1 Participants |
| Hollister Uro | Changes in Skin Compared to Before Study | Yes, it is worse | 2 Participants |
Secondary
Feeling of Security During the Day
The patients feeling of security with the bag during the day
Time frame: 4 weeks
Population: ITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SenSura Uro | Feeling of Security During the Day | Poor | 3 Participants |
| SenSura Uro | Feeling of Security During the Day | Good | 7 Participants |
| SenSura Uro | Feeling of Security During the Day | Reasonable | 5 Participants |
| SenSura Uro | Feeling of Security During the Day | Very good | 4 Participants |
| SenSura Uro | Feeling of Security During the Day | Very poor | 3 Participants |
| Hollister Uro | Feeling of Security During the Day | Very good | 3 Participants |
| Hollister Uro | Feeling of Security During the Day | Very poor | 4 Participants |
| Hollister Uro | Feeling of Security During the Day | Poor | 4 Participants |
| Hollister Uro | Feeling of Security During the Day | Reasonable | 5 Participants |
| Hollister Uro | Feeling of Security During the Day | Good | 7 Participants |
p-value: 0.55Regression, Logistic
Secondary
Feeling of Security During the Night
The patients feeling of security with the product during the night
Time frame: 4 weeks
Population: ITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SenSura Uro | Feeling of Security During the Night | Poor | 4 Participants |
| SenSura Uro | Feeling of Security During the Night | Good | 6 Participants |
| SenSura Uro | Feeling of Security During the Night | Reasonable | 3 Participants |
| SenSura Uro | Feeling of Security During the Night | Very good | 6 Participants |
| SenSura Uro | Feeling of Security During the Night | Very poor | 3 Participants |
| Hollister Uro | Feeling of Security During the Night | Very good | 3 Participants |
| Hollister Uro | Feeling of Security During the Night | Very poor | 3 Participants |
| Hollister Uro | Feeling of Security During the Night | Poor | 4 Participants |
| Hollister Uro | Feeling of Security During the Night | Reasonable | 6 Participants |
| Hollister Uro | Feeling of Security During the Night | Good | 7 Participants |
p-value: 0.48Regression, Logistic
Secondary
Flexibility of the Product
Evaluation of the ability of the bag to conform with the patients movements (flexibility)
Time frame: 4 weeks
Population: ITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SenSura Uro | Flexibility of the Product | Poor | 0 Participants |
| SenSura Uro | Flexibility of the Product | Good | 8 Participants |
| SenSura Uro | Flexibility of the Product | Reasonable | 8 Participants |
| SenSura Uro | Flexibility of the Product | Very good | 5 Participants |
| SenSura Uro | Flexibility of the Product | Very poor | 1 Participants |
| Hollister Uro | Flexibility of the Product | Very good | 3 Participants |
| Hollister Uro | Flexibility of the Product | Very poor | 1 Participants |
| Hollister Uro | Flexibility of the Product | Poor | 4 Participants |
| Hollister Uro | Flexibility of the Product | Reasonable | 5 Participants |
| Hollister Uro | Flexibility of the Product | Good | 10 Participants |
p-value: 0.4Regression, Logistic
Secondary
Immediate Adhesion
Evaluation of immediate adhesion after each period
Time frame: 4 weeks
Population: Intention to treat (ITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SenSura Uro | Immediate Adhesion | Poor | 1 Participants |
| SenSura Uro | Immediate Adhesion | Good | 7 Participants |
| SenSura Uro | Immediate Adhesion | Reasonable | 8 Participants |
| SenSura Uro | Immediate Adhesion | Very good | 4 Participants |
| SenSura Uro | Immediate Adhesion | Very poor | 1 Participants |
| Hollister Uro | Immediate Adhesion | Very good | 5 Participants |
| Hollister Uro | Immediate Adhesion | Very poor | 1 Participants |
| Hollister Uro | Immediate Adhesion | Poor | 4 Participants |
| Hollister Uro | Immediate Adhesion | Reasonable | 4 Participants |
| Hollister Uro | Immediate Adhesion | Good | 6 Participants |
p-value: 0.96Regression, Logistic
Secondary
Problems With Splashing Sounds During Use
The patient was asked whether he/she noticed any splashinh sounds during use
Time frame: 4 weeks
Population: ITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SenSura Uro | Problems With Splashing Sounds During Use | Very much | 0 Participants |
| SenSura Uro | Problems With Splashing Sounds During Use | A little | 4 Participants |
| SenSura Uro | Problems With Splashing Sounds During Use | Some | 3 Participants |
| SenSura Uro | Problems With Splashing Sounds During Use | Not at all | 15 Participants |
| SenSura Uro | Problems With Splashing Sounds During Use | Much | 0 Participants |
| Hollister Uro | Problems With Splashing Sounds During Use | Not at all | 15 Participants |
| Hollister Uro | Problems With Splashing Sounds During Use | Much | 0 Participants |
| Hollister Uro | Problems With Splashing Sounds During Use | Very much | 1 Participants |
| Hollister Uro | Problems With Splashing Sounds During Use | Some | 3 Participants |
| Hollister Uro | Problems With Splashing Sounds During Use | A little | 4 Participants |
Secondary
Removal of the Bag
How easy/difficult it was to remove the bag
Time frame: 4 weeks
Population: ITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SenSura Uro | Removal of the Bag | Easy | 12 Participants |
| SenSura Uro | Removal of the Bag | Difficult | 0 Participants |
| SenSura Uro | Removal of the Bag | Reasonable | 5 Participants |
| SenSura Uro | Removal of the Bag | Very difficult | 0 Participants |
| SenSura Uro | Removal of the Bag | Very easy | 5 Participants |
| Hollister Uro | Removal of the Bag | Very difficult | 0 Participants |
| Hollister Uro | Removal of the Bag | Very easy | 5 Participants |
| Hollister Uro | Removal of the Bag | Easy | 11 Participants |
| Hollister Uro | Removal of the Bag | Reasonable | 7 Participants |
| Hollister Uro | Removal of the Bag | Difficult | 0 Participants |