There is considerable evidence that discretion of an ostomy pouching system is an important consideration for the comfort and quality of life of a person with an ostomy. A new pouching system has been developed to address this specific need, and thereby improve their self-confidence and quality of life. The novel design incorporates a reduced headspace, offset starter hole in the barrier, improved filter and improved closure system in drainable version. When engaged, the closure system provides a profile similar to that of the closed pouch. While providing these improvements, it is critical that the basic function of the pouching system not be compromised. The discretion and confidence benefits are addressed in a companion presentation. The assessment of core attributes is reported here.
This study was a prospective, unblinded, historically controlled observational study of a one-piece pouch with enrollment targetted to complete with a minimum of 140 subjects (70 evaluating open pouches and 70 evaluating closed pouches). The study received a waiver of review by the NHS REC and was conducted in accordance with basic ethical principles including informed consent and respect for the confidentiality of participants. Each participant satisfied the inclusion and exclusion criteria and provided signed informed consent prior to enrollment. Individual participation was for one week or upon using either 15 closed pouches or 8 open pouches which ever came first. Participants were asked to complete a usage diary for each pouch worn. Results and Conclusions
Results and Conclusions
The new pouches were well accepted with approximately 85% or greater of the wear occasions being rated as being neutral or positive for the attributes such as cutting/application, wear time, security, ease of draining, filter performance and comfort. With the additional benefit of improved discretion, the new pouch should improve self-confidence and quality of life of those with ostomies.