Description

Contrelle Activgard is an innovative solution designed to support women experiencing stress urinary incontinence (SUI) or mixed urinary incontinence (MUI) with a predominance of SUI. Developed by Viveca Biomed Limited, this discreet intravaginal device offers a practical approach to managing urinary leakage, allowing women to engage confidently in daily activities such as laughing, coughing, exercising, and even swimming.

Design and Functionality

Crafted from soft, biocompatible foam, Contrelle Activgard is inserted into the vagina using a reusable applicator, similar to a tampon. Once in place, it gently supports the bladder neck and urethra, enhancing the bladder's positioning to reduce mobility and prevent leakage. Its unique winged arch design ensures an anatomical fit without compressing the urethra, allowing normal urination without the need for removal.

Sizing and Use

The device is available in three sizes—Small, Medium, and Large—to accommodate different anatomical needs. A Sizing Kit is provided to help determine the most effective fit. Before use, the device must be saturated with water, causing it to expand by approximately 30%. It features an attached string for easy removal and can be worn comfortably for up to 16 hours within a 24-hour period. During menstruation, it should be changed every 4 to 6 hours and is not intended for use with tampons or other intravaginal devices.

Safety and Efficacy

Contrelle Activgard is a single-use, non-sterile device that should be disposed of in household waste after use. It is clinically proven to significantly reduce or stop bladder leakage, with no reported cases of Toxic Shock Syndrome (TSS). The device is CE certified as a Class IIa/1b medical device, adhering to stringent safety and quality standards.

Intended Audience

This device is intended for women over 18 years old who are not pregnant, have not recently undergone pelvic surgery, and do not have conditions such as vaginal prolapse or untreated vaginal dryness. It should not be used during sexual intercourse or if the packaging is damaged. Women with manual dexterity challenges should consult a healthcare professional regarding its use.

Clinical Insights

Clinical evaluations have demonstrated Contrelle Activgard's effectiveness in reducing leakage and improving quality of life without altering vaginal pH or flora. With over 6 million devices supplied, it offers a well-documented safety profile, empowering women to manage incontinence discreetly and effectively.