title: Considering the benefits of a new stoma appliance: a clinical trial.
abstract: For people living with a stoma, leakage is one of the main problems compromising quality of life. The right choice of stoma appliance is therefore of utmost importance. This randomised, controlled clinical trial investigated the benefits of a new stoma appliance, SenSura Mio Convex Soft, specifically for people who experience leakage using a flat stoma appliance. The degree of leakage under the baseplate was measured using a new objective method. The study included 38 participants with an ileostomy or colostomy. Results showed that while being flexible and comfortable, the new appliance reduced leakage significantly and provided a better feeling of security when compared with the participants' own flat stoma appliance. The product was the preferred of the convex stoma appliances in the study. This study demonstrated that it may be a solution for people with a stoma challenged by leakage using flat stoma appliances.
authors.affiliation: Scientific Manager, Humlebaek, Denmark.
authors.forename: Trine Møller
authors.initials: TM
authors.lastname: Kruse
authors.affiliation: Senior Scientific Manager, Coloplast A/S, Humlebaek, Denmark.
authors.forename: Zenia Marian
authors.initials: ZM
authors.lastname: Størling
mesh_terms: D003125:Colostomy / Q000009:adverse effects / Q000295:instrumentation* / Q000523:psychology; D018592:Cross-Over Studies; D004868:Equipment Failure; D005260:Female; D006801:Humans; D007081:Ileostomy / Q000009:adverse effects / Q000295:instrumentation* / Q000523:psychology; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
keywords: Leakage; Ostomy; Questionnaires; Stoma