Clinical monitoring of safety and efficacy of organic cotton medical device for light incontinence to prevent skin irritation

Abstract

The prolonged use of absorbent products for light incontinence treatment can lead to the onset of skin irritation side effects. The introduction of “breathable” materials into incontinence devices, such as cotton, represents an essential step for improving skin health. Clinical and in-vitro studies were performed on “Organyc Light Incontinence (bladder leakage control pads)” in order to assess their safety and efficacy, moreover, it was evaluated if their use can prevent the onset of irritant conditions. In-vitro tests were performed to understand if the bladder leakage control pads are able to prevent the onset of irritating phenomena that usually occur during and after the use of non-cotton pads. Regarding the self-evaluation parameters reported, it was noticed that “Organyc Light Incontinence (bladder leakage control pads)” was significantly better than competitor in softness, absorbency and leak protection, protection for sensitive skin, prevention of irritation and redness, breathability, in keeping the person dry, comfort, and the importance of being made by natural ingredients was greatly appreciated. “Organyc Light Incontinence (bladder leakage control pads)” has proven to significantly reduce erythema and oedema of the skin and the vaginal mucous caused by the prolonged use of non-cotton medical device. Results also demonstrated good compliance with use.