DALLAS, May 3 /PRNewswire/ -- Results from a multi-center 12-month
clinical trial reported today at the scientific sessions of the 20th Annual
Society of Urodynamics and Female Urology indicate that Rochester Medical
Corporation's (Nasdaq: ROCM) new FEMSOFT(R) Insert is highly effective and has
a high degree of patient acceptance and satisfaction.  Dr. Larry T. Sirls
(Department of Urology, William Beaumont Hospital, Royal Oak, Mich.), one of
the principal investigators in the trial, said the FemSoft Insert "will likely
become an important treatment option" in physician care for female stress
urinary incontinence.  The Pre-Market Approval (PMA) application for the
FemSoft Insert device, submitted in January, 1999, is being reviewed by the
U.S. Food and Drug Administration (FDA).
    Stress incontinence is a common, often ignored, medical condition.  Public
health experts estimate that close to 6.6 million U.S. women experience stress
incontinence.  Everyday acts (e.g. laughing, sneezing, coughing), simple
physical exertion (e.g. standing up, lifting a child or bag of groceries), or
exercise (e.g. dancing, aerobics, golf, tennis) all can trigger this type of
involuntary loss of urine.

    First Soft, Conformable Treatment Option
    The FemSoft Insert is a small, single-use liquid and silicone device that
a woman inserts into her urethra.  The latex-free device consists of a soft,
thin, fluid-filled silicone sleeve.  As a woman inserts the device, the soft
liquid sleeve easily slides into and conforms to her urethra forming an
effective seal at the neck of the bladder.  It is removed during regular
bathroom visits where it is discarded and then replaced by a fresh insert.
    Physicians now treat female stress incontinence using a range of
modalities including strengthening pelvic floor muscles, prescription drugs,
and surgery.  Other minimally invasive devices also have been available but
have been slow to gain acceptance because physicians and patients found them
too uncomfortable, cumbersome to use, and associated with unacceptable adverse
event rates.
    In contrast, Dr. Sirls characterized the FemSoft Insert as simple to use
and "as soft as a woman's body tissues."  He said the FemSoft  Insert is "a
significant improvement over urethral devices introduced over the last several
years which proved to be uncomfortable and had higher complication rates."

    Clinical Findings
    Dr. Sirls presented the results from a study of 150 women enrolled in a
one-year multi-center trial.  The participating women had experienced stress
urinary incontinence for an average of 10.9 years; 42 percent of the study
participants previously had tried other incontinence treatments.  Overall, the
minimally invasive device was highly effective and had a high level of patient
acceptance with low levels of adverse effects.
    The study results reported today are based on the 70 women who have
completed one year of follow-up to date.  After twelve months, urine leakage
with a FemSoft Insert in place was 0.5 grams, compared to 26.3 grams without
the device.  Practically speaking, there was virtually no leakage with a
device in place during the Pad Weight Test and 26 grams of leakage (equivalent
to a medicine cup full) without a device.
    At the end of a 12-month period, 82 percent of participants reported they
had virtually no leakage when using the FemSoft Insert.  Participants reported
a high level of satisfaction, with 94.8 percent of the women indicating a
desire to continue using the device.  A measurable and statistically
significant improvement in the quality of life score was observed.

    Independent Corroboration as an Important Treatment Modality
    During a separate panel discussion on the range of incontinence treatment
modalities at the 20th Annual Society of Urodynamics and Female Urology
sessions, Dr. Michael Kennelly (a practicing urologist with McKay Urology
Associates in Charlotte, N.C.) said that clinical data from the FemSoft Insert
study is very promising.
    "We may indeed be witnessing the emergence of an effective and truly
patient-friendly treatment modality for female stress incontinence."  Dr.
Kennelly noted that for many women embarrassment and limited treatment options
have long been barriers to the successful treatment of women with this
condition.  The American Urological Association just launched an important
multi-year public health education program to reach the millions of women who
still are not getting adequate treatment for urinary incontinence.

    FemSoft Insert Builds on Core Competence of Rochester Medical
    "We are very encouraged by the clinical results for the FemSoft Insert and
remain optimistic about the FDA's ruling on our PMA application," said Anthony
J. Conway, President and Chief Executive Officer of Rochester Medical
Corporation.  "Our company focus is in innovative urinary continence treatment
options and we thoroughly believe the FemSoft Insert's breakthrough liquid
encapsulation technology can effectively help women with urinary stress
incontinence regain their self-confidence and active lives."
    Rochester Medical Corporation is a leading developer of innovative,
technologically advanced, latex-free urinary continence products for the home
care and acute care (hospital) markets.  The company's home care products
include a line of male external catheters for the management of male
incontinence and a line of  intermittent catheters for the management of male
and female urinary retention.  The company's hospital products include a line
of silicone Foley catheters plus the advanced Release-NF(TM) antibacterial
Foley catheter for the prevention of hospital acquired urinary bacterial
infection.
    Headquartered in Stewartville, Minnesota, Rochester Medical uses
proprietary, patented technology for the manufacture of its currently marketed
devices, and continues to research and develop new products based on its
technology.
    The immediately preceding document contains forward looking statements
that involve risks and uncertainties.  The FemSoft Insert has not been
authorized by the FDA for commercial sale, and the commercial success of the
FemSoft Insert is subject to the uncertainty of market acceptance of the
device.  Other risks and uncertainties include the timing and results of FDA
review, the results of product evaluations, the timing of purchases by
customers, manufacturing capacities for both current and future products, the
results of clinical tests, the timing of clinical preference testing and
product introductions, as well as other risk factors listed from time to time
in the Company's SEC reports including, without limitation, the section
entitled "Risk Factors" in the Company's Annual Report on Form 10K (Part II,
Item 6)  for the fiscal year ended September 30, 1998.

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