Q-Med announces results of North American clinical study of ZUIDEX

Q-Med today announced the top-line result from the North American pivotal study investigating the safety and efficacy of ZUIDEX in treating stress urinary incontinence in women (SUI). The goal of this program is to simplify the management of SUI and make treatment available to more women.

The pivotal trial of ZUIDEX was a double blind comparison of ZUIDEX treatment to a collagen based substance in more than 300 patients. The primary objective of the study was to show similar improvement in urinary leakage at the 12 month follow-up assessment, using a standardized short-term office pad test for both treatments.

Improvement in incontinence was noted at 12 months compared to baseline with both treatments and the proportion of subjects subjectively assessed to be continent at the 12 month assessment was similar. The study unfortunately failed to meet its primary end-point as measured by the short-term pad test. Further, the collagen subjects generally required significantly more injected gel during the treatment. The data will now be further analyzed. However, Q-Med’s assessment is that the study result will not be sufficient to successfully support a US ZUIDEX application for market approval (PMA application).

“We are of course very disappointed with the outcome of the study, especially as the effect of ZUIDEX in the study is similar to what have been shown in previous studies. Since ZUIDEX and the device IMPLACER, were launched in Europe in 2002 we have learnt a lot about the SUI affected women, the health care systems and how our product may play a significant role in the management of SUI. Going forward we will determine how we best can integrate ZUIDEX, and potentially additional product concepts, in the established SUI management recommendations”, commented Dr Bengt Ågerup, CEO of Q-Med AB.