Renal and Urogenital Urological and Genital Diseases Other specified urinary incontinence
Conditions
Interventions
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.
Sponsors
Albert Medical Devices (UK)
Eligibility
Sex/Gender
Male
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: Patients whose need for a catheter is under active review
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| To demonstrate the practicality of the Melio leg bag system in a self-use setting. | — |
Countries
United Kingdom
Outcome results
None listed