Condition category
Urological and Genital Diseases
Date applied
23/12/2013
Date assigned
21/01/2014
Last edited
21/01/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and Study Aims
The purpose of the study is to find out what people who use urine drainage bags with their external sheath drainage system think about a new urine drainage bag product.
The Melio leg bag system has been designed to help users to manage their own leg bags, by reducing the need for carers or family members to assist with emptying the leg bag. It has a pump and long drainage tube to allow users to empty the bag without having to bend down or work a tap. It also has a fill alarm that alerts users when their leg bag needs emptying.
We would like to know whether users find the Melio leg bag system easy to use, and to hear their opinions about the pump and the fill alarm.

Who can participate?
Men over the age of 18 who are long-term users of external sheath drainage systems are invited to take part in the study. All participants will be recruited from users of the Rotherham NHS Trust Continence service.

What does the study involve?
Participants in the study will use the Melio Leg bag for 3 weeks. They will keep a diary whilst they are using the Melio Leg bag and will also complete a questionnaire about their experience of using the Melio Leg bag system.
The diary will have space for participants to write down:
• When the fill alarm sounds
• When they empty their leg bag
• How much urine they empty from their leg bag
• Any problems experienced (like leaks or difficulties with the pump)
A continence nurse from the Rotherham NHS Foundation Trust Continence service will visit participants in their home once every week of the study. At these visits they will check for any problems, change the leg bag and collect completed questionnaires and diaries. The visits are likely to last 30 minutes.

What are the possible benefits and risks of participating?
There will be no immediate benefit to patients from taking part in the study. However, it will provide an opportunity to trial a product that may make it easier for them to manage their condition for themselves. If studies show that the Melio bag is beneficial to patients then the overall aim would be to make this product available to patients via the NHS.
The Melio leg bag works in exactly the same way as other drainage bags. The only difference is the way it is emptied. The main risk associated with the study will be patients having difficulty with emptying the Melio Leg bag if they find the pump difficult to use. Patients will be able to contact the continence nurse for assistance if they have any problems whilst using the Melio leg bag. They will also continue to have access to their usual leg bag if they need it.

Where is the study being run from?
Rotherham NHS foundation Trust (UK).

When is study starting and how long is it expected to run for?
The study is expected to begin recruiting in February 2014 and to run until August 2014.

Who is funding the study?
Albert Medical Devices (manufacturer of the Melio leg bag)

Who is the main contact?
Ms Joanne Mangnall, RGN.
Joanne.Mangnall@rothgen.nhs.uk

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Joanne Mangnall

ORCID ID

Contact details

Rotherham NHS Foundation Trust
Moorgate Road
Rotherham
S60 2UD
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1

Study information

Scientific title

Usability study with the Melio leg bag system: a non-randomised controlled trial

Acronym

Study hypothesis

Users will find the novel features of the Melio leg bag system beneficial and the features will assist users in managing their own urine drainage bag.

Ethics approval

Application is being made to Yorkshire and Humber Regional Ethics Committee (REC), expected review in January 2014.

Study design

Controlled trial without randomisation

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Renal and Urogenital

Intervention

Participants will use the Melio leg bag system for 3 weeks. They will keep a diary of their experience with the bag during this time and complete a questionnaire at the end of the study.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

To assess whether end users find the novel features of the Melio leg bag system (a pump for emptying and a fill sensor) to be useful and reliable.

The outcomes will be determined at the end of the study using a combination of a patient questionnaire which will be completed after patients have used the leg bag for three weeks, and diaries which participants will keep throughout the study.

Secondary outcome measures

To demonstrate the practicality of the Melio leg bag system in a self-use setting.

Overall trial start date

01/02/2014

Overall trial end date

31/08/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Males over 18 years of age who use external sheath drainage systems and patients of Rotherham NHS Foundation Trust continence service
2. Able to understand the Melio Leg bag system instruction for use and to complete the study questionnaire (they may have a carer who will assist with these activities)
3. Able to give written informed consent to participate

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

12

Participant exclusion criteria

Patients whose need for a catheter is under active review

Recruitment start date

01/02/2014

Recruitment end date

31/08/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Rotherham NHS Foundation Trust
Rotherham
S60 2UD
United Kingdom

Sponsor information

Organisation

Albert Medical Devices (UK)

Sponsor details

Ic1 Innovation Centre
131 Mount Pleasant
Liverpool
LV3 1SU
United Kingdom

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Albert Medical Devices (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes