UPPSALA, Sweden, Aug. 25, 2004 (PRIMEZONE) -- A new large European study shows that most women suffering from stress urinary incontinence can be helped. Almost eight out of ten women who have been treated using the Swedish method ZUIDEX have considerably fewer problems and a higher quality of life after one year.
"The results of the study confirm our experience and earlier reported results and I urge women to seek treatment. Incontinence is taboo but there is help available," says Associate Professor Aino Fianu Jonasson, senior physician at the women's clinic at Karolinska University Hospital, Huddinge, Sweden, and one of the investigators in the study that has been carried out at sixteen centres in Sweden, Germany, England, France and Italy.
The study is being presented today at the International Continence Society's congress in Paris, France.
In the study, the leakage of urine in the patients was measured in a standardized way. The patients were then treated with Zuidex, a Swedish method involving the injection of a gel of hyaluronic acid and dextranomer into the urethra. The intervention is performed under local anesthesia and takes only a few minutes. The patient can usually go home after a couple of hours and does not need to take sick leave. The effect is immediate.
The patients in the study were followed up on seven occasions after the treatment. After twelve weeks and after six months, 78 and 79 percent respectively had responded to the treatment*. The effect was sustained at the last measurement after 12 months (77 percent). The leakage in the patients decreased on average (median value) by 93% compared with the original measurement. A majority of the patients stated that they now have a higher quality of life as the incontinence has affected their sex life, social life, physical activities and relationships to a considerably lesser extent. No unanticipated adverse events were reported in the study.
Further, the study also consisted of a cost effectiveness section, analyzing the total cost of a Zuidex treatment. The results suggest that treatment with Zuidex is a cost effective alternative compared to one of the most common treatments used today (TVT or Tension-Free Vaginal Tape).
In all, 142 patients participated in the study. The average age was 55.7 years and more than half of the women had suffered from incontinence for more than five years. All of them had previously undergone training of the muscles of the pelvic floor.
Approximately half a million Swedes suffer from some form of incontinence. The great majority are women, and a common estimate is that as many as one third of adult women are affected. The most common form of the disorder is stress urinary incontinence, which just over 200,000 Swedish women live with. The condition affects both the young and the elderly but is more and more prevalent with increasing age. It often arises after pregnancy and childbirth.
The study will continue in the form of a long-term follow-up (2 -- 3 years).
"Hopefully, the more we talk about how women's lives are limited by incontinence and about the fact that treatment is available, the more women will feel that it is worth seeking medical help," says, Aino Fianu Jonasson.
* Decrease in leakage upon provocation test by 50% or more compared with the original measurement
For more information, please contact:
Bengt Agerup, President and CEO, Q-Med, phone +46 (0) 18- 474 90 00, mobile +46 (0) 709- 74 90 25, b.agerup@q-med.com Anna Eriksrud, Vice President Hospital Healthcare, mobile +46 (0) 070- 974 90 92, a.eriksrud@q-med.com Aino Fianu Jonasson, Associate Professor, Senior Physician, Women's Clinic, Karolinska University Hospital, Huddinge, mobile: +46 (0)70-483 60 28
ZUIDEX
The ZUIDEX treatment is the latest advance in the treatment of women with stress urinary incontinence. ZUIDEX consists of two natural sugars, dextranomer and hyaluronic acid (NASHA- Non-Animal Stabilized Hyaluronic Acid) and an implacement device, IMPLACER, that significantly simplifies the procedure by guiding the substance to the appropriate area. Both Dextranomer and Hyaluronic Acid have been extensively used in other medical applications for decades. Dextranomer is widely used, among other, in the treatment of wounds; and Hyaluronic Acid is present in all the body tissues and is used in both eye surgery and cosmetic applications. Both substances are non-allergenic, and are produced using a biotechnological (non-animal) process.
Q-Med is a rapidly growing and profitable biotechnology/medical device company that develops, produces and markets medical implants. All products are based on the company's patented NASHA technology -- Non-Animal Stabilized Hyaluronic Acid. The products covered by the RESTYLANE trademark are used for the filling out of lips and facial wrinkles and for facial contouring and today account for the majority of sales. RESTYLANE is sold in over 70 countries and has been approved in the USA. DUROLANE, Q-Med's product for the treatment of osteoarthritis of the hip and knee joints, has been approved in Europe since May 2001. DEFLUX is a product which has been approved in Europe and the USA for the treatment of vesicoureteral reflux (malformation of the urinary bladder) in children. ZUIDEX for the treatment of stress urinary incontinence in women has been sold in Europe since July 2002 and in Canada since 2003. Q-Med today has approximately 500 employees, with approximately 320 at the company's production facility and head office in Uppsala. The Q-Med share is listed on the Attract 40 list of the Stockholm Stock Exchange.
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