Preclinical and clinical safety and efficacy assessment of an organic cotton medical device for the management of moderate to heavy urinary incontinence

Abstract

Urinary incontinence (UI) is a widespread condition affecting about 200 million people worldwide, with women affected more often than men and prevalence increasing with age. UI is a significant health problem that negatively impacts affected women’s well-being, sociality, and productivity. Therefore, seeking medical advice is highly recommended since valid treatment options exist. However, a definitive solution to the problem is not always possible. In these cases, absorbent containment products can help women deal with the persistent symptoms of incontinence, minimising the effects on the quality of life. High-quality products are paramount to avoid or reduce the onset of irritating skin phenomena, which can sometimes lead to more serious consequences, such as skin infections. Cotton is a natural fibre characterised by softness and hypoallergenic properties that has already shown its ability to improve skin health when used as a component of pads and other absorbent containment products. The aim of this work was to assess the safety and efficacy of a new organic cotton pull-on absorbent product in reducing skin erythema and oedema in women suffering from moderate to heavy urinary incontinence. In-vitro and clinical studies were performed. Results showed that the tested product effectively reduces skin erythema and oedema caused by the conventional use of synthetic pull-on absorbent products. Moreover, good compliance with the use was demonstrated compared to a non-cotton competitor device available on the market. In conclusion, the organic cotton absorbent device tested has improved the quality of life of women suffering from moderate to heavy urinary incontinence.