A condition that affects over two million men, stress urinary
incontinence (SUI) is often a disturbing complication that follows the
surgical removal of the prostate. Until now, there have been few
options for treatment of this embarrassing condition.
A large sample study reports that the ProACT(TM) (Adjustable
Continence Therapy) has demonstrated to be a safe, effective and
durable treatment for male stress urinary incontinence. The long-term
study, titled International multi-center evaluation of the ProACT for
male post prostatectomy stress urinary incontinence by Gilling, P. et
al., reports that 65% of patients were dry (less than 1 pad a day) at
two years. In addition, patients reported a significant improvement in
quality of life (from 41.6 before the procedure to 74.6 at two years
after the procedure, on a scale from 0-100).
First used in 2000 in Austria by Dr. Wilhelm Hubner (one of the
co-investigators in this study), the ProACT device was implanted in
329 male patients in four international centers between 2001 and 2005.
These patients suffered from incontinence arising from multiple
etiologies (but predominantly post radical prostatectomy
incontinence). "The promising results reported here suggest that this
may be an appropriate, effective and durable first-line treatment to
offer men with stress urinary incontinence after prostatectomy", said
Dr. Wilhelm Hubner, Director of the Urology Department at the Humanis
Clinic in Korneuburg. Study findings will be presented at the European
Association of Urology (EAU) Annual Meeting (March 26-29) in Milan,
Italy. For information on this and other studies, go to
www.uromedica-inc.com.
ProACT(TM) therapy and ACT(R) (Adjustable Continence Therapy) were
developed by Uromedica and approved in Europe in 2002. Based on
patented technology, the balloon volume can be percutaneously
increased or decreased to meet the needs of the individual patient.
The ProACT is the first-line treatment for post-prostatectomy urinary
incontinence in men, and the ACT device treats stress urinary
incontinence in women who have not responded to other interventions.
About Uromedica
Uromedica, Inc. was formed in 1997 to develop minimally invasive
medical devices that treat unmet medical needs in the area of
urogenital and related disorders. Fourteen million people suffer from
stress urinary incontinence, an embarrassing condition that produces a
significant cost to society and a disturbing trend as the population
increases. The use of ACT and ProACT is growing significantly, and to
date, around 6000 patients have been implanted with this minimally
invasive device which can be non-invasively adjusted until the patient
reaches the desired level of continence. The company is in the final
stages of clinical studies needed to obtain FDA approval, with
submission expected in Fall 2008.
ProACT(TM) and ACT(R) are not available in the United States and
are available in selected markets outside the United States.
