The DialogueStudy, an open-label, non-comparative, multinational post-marketing study, was set up to document real-life experiences of users of a new ostomy appliance, SenSura, manufactured by Coloplast A/S, with a focus on quality of life (QoL) and peristomal skin conditions. The largest study of its kind, the DialogueStudy involved more than 500 stoma care nurses (SCNs) from 379 sites in 18 countries and a total of 3017 participants with a colostomy, ileostomy or urostomy. During the study, participants completed two visits with an SCN and were given advice on maintaining healthy peristomal skin and provided with an appropriate ostomy appliance, SenSura. The primary endpoint was the difference in QoL between the first and second visit. Secondary endpoints included self-awareness of skin disorders, leakage and peristomal skin condition at the study start and then at the study end (6–8 weeks later). The mean QoL score increased significantly during the study (P<0.0001).
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