"
About the Problem (Benign Prostate Hyperplasia - Enlarged Prostate)
Virtually
every other man over the age of 50 will over time be affected by
urination problems due to benign
prostate hyperplasia, BPH. These
minimally invasive methods involve the use of microwave thermotherapy
to
reduce the size of the prostate. No
other minimally invasive, microwave thermotherapy devices
have these
capabilities.
An observational study published in the May 2005 issue of The
Journal of
Sexual Medicine found that patient-reported outcome measures (PROs), such as
control
over ejaculation, satisfaction with sexual intercourse and distress
are important factors in assessing
the benefit of treatments for PE in
clinical studies.
*Intravaginal Ejaculatory Latency
Time (IELT) - IELT was first introduced
in 1994.
disorder webmd
Unlike Johnson and Johnson's Dapoxetine, an oral
treatment under development, NM100061 is applied locally.
Dr.
In the past few years
, a new type of minimally invasive methods to treat
BPH have become the treatment of choice for more
and more patients.
Prostalund has approximately forty employees in Sweden, a subsidiary in
Germany
, and sales and distribution organizations throughout Europe, the
Middle East, China and the rest
of the world. Patients were asked to take study medication one-to-three hours
before intercourse
.
-- The percentage of men rating control over ejaculation as "fair to very
good
" increased dramatically for dapoxetine 30 mg (2.
-- The percentage of men rating sexual satisfaction
as "good to very good"
almost doubled with dapoxetine 30 mg (20. It can affect his and his
partner's sexual
satisfaction and their ability to build and maintain relationships -- both
sexual
and non-sexual - and can impact a man's general sense of self-
confidence., has a proven
track
record of leadership in the field of urology and is committed to
providing patients with products
that help them live healthier lives and
improve their quality of life.cope depth
Participants had IELT of
two minutes or less in at least
75% of intercourse episodes occurring during the two-week baseline
run-in
period prior to treatment.4%) compared to placebo (3.6% to 24. The most common adverse
events
reported with both 30 mg and 60 mg doses of dapoxetine were nausea,
followed by headache.infocenter causes
S. Prostalund
is the developer and manufacturer of
the unique and patented CoreTherm medical device for treatment
of benign
prostatic hyperplasia, based on a unique customized microwave treatment
that takes place
while monitoring the temperature of the prostate.
The results showed:
-- Men taking dapoxetine
30 mg and 60 mg experienced more than a three-to-
four fold increase in mean IELT compared
with placebo (P-value <0.6%).2%).incidence resolve
Addressing a patient's BPH
problem often becomes a choice between
surgery, a minimally invasive
procedure or symptom-controlling medication. The company's operations
are
carried out in close collaboration with leading universities and hospitals
in Sweden, the
U.
The study also found that dapoxetine was generally well tolerated, with
most side effects
of mild-to-moderate severity.premature incidence
Prostalund AB, a Swedish developer and
manufacturer of medical
devices, today announced the opening of Prostalund,
Inc.
ProstaLund is the developer of CoreTherm
, a unique medical device that
utilizes minimally invasive, microwave thermotherapy to treat an enlarged
prostate (BHP - benign prostatic hyperplasia), which affects millions of
men in the U. "Our new
Los Angeles office will allow
us to fully develop the U. Prostalund's CoreTherm method utilizes
its own innovative technologies to provide temperature feedback and control
during the procedure
in order to produce better results. Pryor, M.factors ejaculation
and Canadian markets.
Adjustable Microwave Power
/Temperature Control: CoreTherm allows the
physician to precisely adjust the temperature to treat
each individual
patient's condition.
According to the American Urological Association, premature
ejaculation
may be the most common male sexual disorder.3%
to 46.Premature ejaculation
is a common problem among men.
afflicted bearing
NexMed, Inc. Gittelman's four presentations are titled:
-- Synergistic effect of meatal application of dyclonine/alprostadil
cream for the treatment
of Early Ejaculation ("EE") in a double-blind and
crossover study
-- The use of the female
sexual function index to assess the efficacies
of an alprostadil cream in a placebo-controlled
, double-blind study in
patients with female sexual arousal disorder
-- A placebo-controlled
, double-blind study of the efficacy and safety of
an alprostadil topical cream in patients with
female sexual arousal
disorder
-- Effects of an alprostadil cream on sexual arousal response
in
premenopausal women with female sexual arousal disorder
Copies of the abstracts
are available through NexMed. The
Company is also working with various pharmaceutical companies
to explore
the incorporation of NexACT into their existing drugs as a means of
developing new
patient-friendly transdermal products and extending patent
lifespans and brand equity.S.
"The impact premature ejaculation can have on men and their partners can
be devastating for a relationship
and, currently, there are no truly optimal
therapies for PE," says Jon L.7%) and 60 mg (22. The
study found that men with PE and their partners
reported higher ratings for interpersonal difficulty
, lack of control over
ejaculation and dissatisfaction with sexual intercourse. The amount
of time
this process takes is known as intravaginal ejaculatory latency time
or IELT.expectations premature
There are
meaningful
improvements in this study across all primary and secondary
endpoints, including a three-to-four
fold increase in IELT. Most physicians do not screen for
PE and patients are extremely reluctant
to talk about the condition with their
partners or health care professionals.afflicted disorder
Dr., based in Los
Angeles, is a wholly owned subsidiary of
Prostalund AB in Sweden.First Medication Developed To Treat
Premature Ejaculation Demonstrates Improvement In Control Satisfaction And Time
, chairman and program
director of
the Department of Urologic Surgery at the University of Minnesota and lead
investigator
of the dapoxetine phase III clinical trials.considered participation
IELT increased significantly with the first dose
of dapoxetine, and increases in IELT were maintained over the 12-week
study period.webmd participation
It is now available to hospitals,
clinics, and physicians in the U.
The
U. PE can have
a significant impact on
many aspects of a man's life.
** Represents Hispanic, Caucasian
, and African American men.caused disorder
, a wholly owned subsidiary based in Los Angeles, California. Without this
monitoring, patients are frequently (up to 40%) under treated, which leads
to less than optimal
results or even the need to be treated again in the
future.coretherm.D. A stopwatch may be operated
by either partner and is activated
when the male enters the female and stopped when a man ejaculates
.condition disorder
PRESS RELEASE New CoreTherm Medical Device Treats Enlarged Prostates Faster With Optimum Results
(Click here for details)
"We believe CoreTherm offers the best treatment option for the millions
of
men with moderate to severe symptoms of BHP," stated Magnus Bolmsj,
founder and CEO of ProstaLund
AB.
Best Results: CoreTherm is the only minimally invasive microwave
thermotherapy device
that consistently reduces patient symptoms from severe
to mild."
Phase III Trial Design
and Results
The phase III clinical trials studied 2,614 men with PE aged 18-77 in
monogamous
sexual relationships of greater than six months.
Contacts:
Peggy Ballman
Effie Delimarkos
Ortho Urology Ortho Urology
Cell: 908/310-7721
Cell: 908/675-0152
Office: 908/927-3629 Office: 908/218-7542
bearing fiore
This control
is important because it reduces the
chances the prostate is either over treated or under treated
. "The results with
dapoxetine are compelling.5% to 51.2% to 38.resolve completion
S.Phase III Clinical Trial Results
for Dapoxetine Hydrochloride Offers Hope for
Men Suffering from a Common Male Sexual
Dysfunction
SAN ANTONIO, Data presented today demonstrates that
men taking dapoxetine
hydrochloride for the treatment of premature ejaculation
(PE) experienced significant improvements
in sexual function, including
ejaculatory control, satisfaction with sexual intercourse for men and
their
partners, and increases in intravaginal ejaculatory latency time (IELT)*. PE can be a lifelong
condition experienced from the
beginning of sexual activity or can develop after years of satisfactory
sexual
activity. By definition, ejaculation of the male prior to completion of the sexual act is
considered premature ejaculation.
fiore depth
PRESS RELEASE NexMed Presents New Data at ESSM Including Data on
Early Ejaculation Product
EE, commonly known as premature ejaculation, is the most prevalent
male
sexual dysfunction, affecting as many as one-third of men worldwide at some
time in their
lives. is an emerging drug developer that is leveraging its
proprietary drug technology to develop
a significant pipeline of innovative
pharmaceutical products to address significant unmet medical
needs. It is estimated that PE may
affect 27% to 34% of men across all age ranges**, in contrast
to erectile
dysfunction, which is estimated to affect 10% to 12% of all men, who are
usually older
in age.4%).
-- The percentage of partners rating sexual satisfaction as "good to very
good" almost doubled with dapoxetine 30 mg (20.
About Premature Ejaculation (PE)
Although PE is one of the most common male sexual disorders, it remains
widely under-diagnosed
and under-treated.definition factors
This condition
causes troublesome symptoms and anxiety that adversely affects
quality of
life for millions of men around the world.
Accurate Monitoring of Intraprostatic
Temperature: By accurately monitoring
the temperature of the prostate during the procedure, physicians
can see
the real-time effects of the treatment in progress.
Fastest Treatment Time: CoreTherm
treats patients in 10-15 minutes, while
other microwave thermotherapy devices require 30-60 minutes
of treatment.com. Food and Drug Administration is currently reviewing a New Drug
Application for
dapoxetine, which if approved, would be the first prescription
product indicated for the treatment
of PE.
Men in the studies were randomized to receive 30 mg or 60 mg of dapoxetine
over 12
weeks in two identical, double-blind, placebo-controlled, multicenter
trials.
The studies
examined changes from baseline for mean IELT as monitored by a
stopwatch; measured the subject's
ejaculatory control and sexual satisfaction
on a five-point scale from "very poor to very good";
and measured the
partner's satisfaction with sexual intercourse from "very poor to very good".5%
to 26.prior premature
NexMed, Inc.
CoreTherm received FDA approval in 2003 and has successfully treated
approximately 15,000 patients worldwide.webmd depth
These data were presented at the
100th Annual Scientific
Meeting of the American Urological Association. The unique profile of dapoxetine translated
into
targeted treatment of PE compared to existing therapies.8%) and
60 mg (3.1% to 25.expectations premature
Patients
greatly appreciate this benefit.
About Prostalund
ProstaLund, Inc.S.4% to 39%) and 60
mg
(24.participation bearing
Marc Gittelman, MD, FACS, Director of the Miami
Center for Sexual Health and a
NexMed consultant, will make four
presentations at the 8th Annual Meeting of the European Society
for Sexual
Medicine ("ESSM"), which takes place December 4-7, 2005 in Copenhagen,
Denmark.
About NexMed, Inc.
market and support physicians and healthcare
organizations with a product
designed to improve patients' lives and well
being.S.5%), respectively, in comparison to placebo
(21.4%), respectively, compared to placebo (20.definition tcm
, and around the world. PE was defined as
persistent
or recurrent ejaculation sooner than desired either before or
shortly after penetration, typically
reflecting an IELT of two minutes or
less, over which the sufferer has minimal or no control.8% to
47. It is used in clinical setting involving the study of premature
ejaculation.disorder condition
Gittelman's presentations
will include data on NM100061,
NexMed's proprietary early ejaculation ("EE") treatment under development
. Other minimally invasive procedures only reduce the symptoms from
severe to moderate. at (310)
559-6015 or visit their Web site at
www. They demonstrate that, for the first time, a
medicine
can be taken by men on an on-demand basis and provide significant
improvement in their PE condition
.0001
at 30 mg and 60 mg). Ortho Urology has a history of clinical
expertise and is committed
to bringing patients the most advanced options in
urology with products such as ELMIRON(R) and DITROPAN
XL(R).ejaculation expectations
(NASDAQ: NEXM), a developer
of innovative treatments based on the NexACT drug delivery technology
,
today announced that Dr. CoreTherm, administered on an outpatient basis, provides
the fastest
treatment for patients, produces results equivalent to surgery,
and has lower costs than surgery
or drug therapy.
About CoreTherm
CoreTherm's unique features and patented design make
it the most advanced
minimally invasive procedure available today for the treatment of BHP.
For
more information including clinical findings, sales, and distribution,
contact Prostalund, Inc.3
% to 58.
About Ortho Urology
Ortho Urology, a unit of Ortho-McNeil Pharmaceutical,
Inc. Age has no bearing upon the individual afflicted with the disorder.
condition fiore
Working overtime to stay the Web's best reference!
-> Show SiteSeek's List of Web Sites For This Topic (Not Yet Peer Reviewed)
Loading...
(Note: These pages use the Atlas Content Safeguard System (ACSS) and require that Javascript is enabled for viewing.)