Q-Med announces results of North American clinical study of ZUIDEX 2007-07-12 08:01 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.
Do Periurethral Zuidex Injections Alter the Performance of Tension-Free Tapes in the Treatment of Stress Urinary Incontinence? Chris Blick, Nilay Patel, Stephen J. Foley Department of Urology, Royal Berkshire Hospital, Reading, UK Address of Corresponding Author Curr Urol 2010;4:15-17 (DOI: 10.1159/000253402) -------------------------------------------------------------------------------- Key Words Zuidex Transobturator tape Stress urinary incontinence -------------------------------------------------------------------------------- Abstract Introduction: A proportion of patients with ongoing stress urinary incontinence (SUI) following periurethral injections may wish to consider further intervention in the form of a tension-free obturator tape. This study aims to establish whether the presence of periurethral Zuidex alters the operative procedure or affects the success rate of subsequent tension-free tape surgery. Patients and Methods: In a study of 200 consecutive female patients suffering from SUI managed with the urethral bulking agent Zuidex we reported a 62% success rate. Twenty-two of 76 patients who continued to suffer from SUI following periurethral Zuidex opted for further surgical intervention in the form of a tension-free tape. The median age of the patients was 63 years and the time between Zuidex treatment and tension-free tape insertion ranged from 5 to 31 months (median 6.8 months). Results: The presence of the bulking agent did not alter surgical technique or increase the complexity of tape insertion. Twenty of 22 (91%) women were pad free after tension-free tape and 2 patients reported an increase in lower tract symptoms (cystoscopy normal). Conclusions: In our experience the success of transobturator tape surgery for stress incontinence is not adversely affected by the previous use of periurethral injections of Zuidex. Copyright © 2010 S. Karger AG, Basel -------------------------------------------------------------------------------- Author Contacts Chris Blick, Urology Procedures, Royal Berkshire Hospital, London Road, RG1 5AN Reading (UK), Tel. +44 0118 322 8310, Fax +44 0118 322 8233, E-Mail cblick@doctors.org.uk -------------------------------------------------------------------------------- Article Information Received: July 3, 2009 Accepted: November 10, 2009 Published online: January 28, 2010 Number of Print Pages : 3
yeah sorry, bulking agents seem to migrate (remember the silicone product...) Supplimental as an adjunt to other therapies...has its place...should be purchased by either JNJ, BSX, AMS ect....
