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Significant Improvement in Stress Urinary Incontinence Seen With Zuidex System: Presented at ICS

By Jill Stein

PARIS, FRANCE -- August 25, 2004 -- Use of the Zuidex system to treat stress urinary incontinence is a standardised and highly effective procedure that is associated with significant decrease in urinary leakage and is well tolerated, investigators reported here on August 25^th at the Joint Meeting of the International Continence Society and the International UroGynecological Association.

Chris Chapple, MD, Consultant Urologist, Royal Hallamshire Hospital, Sheffield, United Kingdom, reported results in 139 patients who were treated with Zuidex.

The Zuidex system comprises four pre-filled syringes of non-animal, stabilised hyaluronic acid/dextranomer (NASHA/Dx) gel and an Implacer device.

NASHA/Dx gel is a biocompatible and biodegradable material, consisting of dextranomer microspheres (80 to 250 mcm in diameter) suspended in a carrier gel of NASHA. It has no immunogenic properties and has been shown not to migrate to different organs in the body following submucosal injection. The Implacer device allows accurate placement of four implants into the urethral submucosa without endoscopic guidance and can be performed in the absence of surgical facilities.

The present study was designed to satisfy the requirements of Good Clinical Practice for U.S. Food and Drug Administration-regulated clinical trials as well as applicable regulatory requirements.

All subjects had a history of stress urinary incontinence for at least 1 year, had failed noninvasive therapy, and had not yet tried invasive therapy. Patients were assessed for urodynamics and underwent a provocation test to confirm the presence of stress urinary incontinence.

Results showed that 49% of patients considered themselves dry or significantly improved 8 weeks after the start of treatment, and 44% needed re-treatment.

Significant decreases in leakage on provocation testing were seen at all assessments after the initial treatment, with no sign of worsening during the 6-month follow-up period. Nearly 60% of patients were essentially dry according to the 24-hour pad-weight test, defined as less than 8 g/24 hours of leakage.

At 6 months, the median provocation test leakage had decreased by 91% compared with baseline. Overall, 73% of patients showed a positive response at 12 weeks and 6 months.

Results also revealed that Zuidex treatment was associated with a decrease in the number of incontinence episodes per day and normal bladder function with no evidence of chronic emptying problems.

About half of patients (54%) reported treatment-related side effects that were usually mild or moderate and typically associated with a procedure of this type.

Dr. Chapple said that this study is the largest Good Clinical Practice trial of urethral injection for stress urinary incontinence performed to date in Europe.

He also noted that the findings are in agreement with the results of a prior study involving 42 patients, which showed that the Zuidex system is an effective and well-tolerated treatment for stress urinary incontinence over a 12-month period, with improvement sustained to 24 months in a follow-up population of 20 patients (van Kerrebroeck, P. Urology. 2004 Aug;64(2):276-81.).

The study was funded by Q-Med AB, Uppsala, Sweden, marketer of the Zuidex system.


[Abstract title: "Efficacy And Safety of the Zuidex™ System for the Treatment of Stress Urinary Incontinence: 6-Month Results of an Open, Multicentre Study." Abstract 314]

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