As we mentioned in previous article, premenstrual syndrome effects over 70% to 90% of women before menopause in US and less for women in Southeast Asia because of their diet. Premenstrual syndrome (PMS) occurrence have more than double over past 50 years due to the acceptance of its as medical condition and caused by unhealthy diet with high in saturated food. Premenstrual syndrome is defined as faulty function of ovaries related to women menstrual cycle, it effects the women physical and emotional state and sometimes interference with daily activities as resulting of hormone fluctuation. The syndrome happens in one or two weeks before menstruation and then declining when the period starts. It is said the symptoms can be so severe that between 10-15% of women have to take time off work, costing businesses millions of dollars a year. In this article, we will discuss what exhibits insomnia to cause PMS.

1. Mineral deficiency
Calcium, magnesium and silicon are essential for women during menstrual cycle because they have a calming effects for the nervous system. Imbalance or deficiency of calcium, magnesium and silicon increase the tension of the brain’s cell resulting in insomnia.

2. Vitamin deficiency
Women with PMS are found to have low levels of vitamin B6 which is vital to convert trytophan to serotonin. Deficiency of vitamin B6 interferes the production of serotonin resulting in lessening the production of melatonin, a vital hormone in promoting a good nigh sleep.

3. Alcohol
Alcohol not only damages the liver in fat and protein metabolism, it also increases the tension of nervous system. Limit intake of less than one cup of wine everyday will helps to reduce the symptoms of insomnia.

4. Caffeine
Caffeine may helps to increase nervous system function but it may causes nervous tension and vitamin B6 deficiency as resulting of caffeine stimulating. It also causes unbalance of production of serotonin and melatonin hormone resulting in increasing the nervous tension leading to insomnia.

5. Low levels of melatonin
Melatonin is hormone which helps to regulate the sleep pattern of our body. some women with PMS found to have low levels of melatonin before period caused by low levels of serotonin and trytophan. Intake of food with high in serotonin and trytophan will help.

5. Insulin irregularity
Researchers exam the inter relationship between insomnia and insulin fluctuation found out that improving insulin balancing will helps to improve the sleep pattern and via versa.

To read the series of PMS,please visit
http://pre-menstrualsyndrome-pmsi.blogspot.com/
To read all articles of women health, please visit
http://medicaladvisorjournals.blogspot.com/

UroToday.com - The etiology of multiple sclerosis (MS)-emergent erectile dysfunction (ED) is still matter of debate, since both organic and psychological factors have been implicated. There is an association between sexual dysfunction (SD) and destructive lesions in the pons, in MS patients. Central and peripheral nerves systems play a key role in the erectile process. The innervation of the penis is both autonomic (sympathetic and parasympathetic) and somatic (sensory and motor). Pudendal nerves have a central role in erection. Tactile stimulation of the penile shaft activates parasympathetic fibers, which travel in the pudendal nerve and function through the spinal reflex arc from S2 to S4. Neural signals originating in the brain are transmitted to a thoracolumbar erection center and trigger the psychogenic erection associated with either fantasy or viewing erotic material. In addition, the ischiocavernosus and bulbospongiosus striated muscles, which located at the penile crus, are innervated by the motor pudendal nerve. Contraction of these muscles has a definite, contributory role in penile erection. Therefore, erection is a neurovascular event, and any disease or dysfunction affecting the brain, spinal cord, or cavernous and pudendal nerves can induce ED. With respect to placebo, sildenafil produced a 16% greater success rate for vaginal penetration, and a 15% greater rate for successful intercourse. For satisfaction with erection hardness, and satisfaction with the sexual experience, sildenafil did not produce two-fold greater rates. For all efficacy variables, sildenafil had similar or slightly greater scores compared with placebo.

Although some clinical trials have demonstrated an overall success rate of greater than 70%, certain patients will be refractory to treatment with sildenafil. Sildenafil acts a potentiator of local mediators to maintain smooth muscle relaxation and thus cannot act in the absence of intact penile innervation. In this study, most of the participants had abnormal pudendal nerve cortical somatosensory evoked potentials (PEPs). The incidence of ED after non-nerve sparing radical retropubic prostatectomy is up to 97%. This is due to cavernosal nerve damage. A poor response to sildenafil in postoperative patients with unilateral or non-nerve-sparing radical retropubic prostatectomy has been demonstrated. Direct-acting medications might be expected to be efficacious in nonresponders who have nerve injury or nerve damage. Fifty percent of the post prostatectomy patients who had failed with sildenafil, reported improved EF with intraurethral alprostadil.

Sexual dysfunction is a frequent disorder associated to MS, which contributes to the worsening of quality of life of these patients. During the course of MS, prevalence of SD becomes increasingly more common, affecting, after 10 years of disease duration, 40-70% of patients.

Interactions between neural structures are essential to all phases of human sexual response and functioning. Neurophysiological studies give invaluable information on the involvement of the parts of the nervous system that are essential in the control of sexual function. The pudendal nerve and its terminal branch (dorsal nerve of the penis) provide somatosensory innervation to the genitalia in men. Sensory pathways, which are important in reflexogenic erections, transmit information to the CNS via the dorsal penile nerve and the pudendal nerve. Therefore, a neurophysiological test that assesses the pudendal nerve function such as the PEPs, has great value in an objective evaluation of SD.

We did not recommend second or third type PDE-5 inhibitors for sildenafil non-responders. All three FDA approved PDE-5 inhibitors are targeting the same site of action. Studies from the industry tend to favor preference for their own drug, whereas independent studies tend to show no major difference in preference. Multiple well-designed studies have shown that, all three available PDE-5 inhibitors, have a very similar efficacy and safety profile. In our experiences, well-educated sildenafil non-responders, seldom respond to other type of PDE-5 inhibitors.

Written by M.R Safarinejad, MD as part of Beyond the Abstract on UroToday.com

UroToday - the only urology website with original content written by global urology key opinion leaders actively engaged in clinical practice.

To access the latest urology news releases from UroToday, go to:
www.urotoday.com

Copyright © 2008 - UroToday

Dr. J. Francois Eid has performed more internal penile implant surgeries than anyone in the world and has built a reputation for excellence in the treatment of erectile dysfunction (ED). After examining the latest generation of Inflatable Penile Prosthesis (IPP) and Artificial Urinary Sphincter (AUS) technologies from American Medical Systems (AMS) and Coloplast Corporation, reviewing pertinent studies, and drawing on his 20 years of experience performing penile prosthesis surgery and overseeing his patients’ recuperation and subsequent training in operating the devices, Dr. Eid has high praise for the recent improvements. Updates have been made to the IPP pumps offered by both AMS and Coloplast, as well as to the CX and LGX cylinders offered by AMS. Also, AMS has added an antibiotic coating to its AUS.

Momentary Squeeze (MS) Pump - AMS

AMS’s Momentary Squeeze (MS) Pump was first introduced nearly two years ago, and Dr. Eid has implanted it with great success in patients suited to the CX-cylinder and LGX-cylinder versions. (The LGX model offers the potential for increased penile length in patients complaining of penile shortening after radical prostatectomy.) Both cylinders now feature redesigned proximal ends. At only 9.5mm in diameter, the ends allow for significantly easier insertion for patients with fibrotic proximal corporal bodies.

The MS Pump’s advantages include a smaller profile (which enables a more discreet placement) and one-touch deflation. However, this quality can result in operational difficulties with inflation (more difficult to get a hold of within the scrotum) and deflation (small button can initially be difficult to find). In addition, its new lockout valve has the advantage of preventing auto-inflation (potentially embarrassing and/or painful), but can at times make it difficult to initiate inflation. For these reasons, Dr. Eid recommends this pump for the younger patient with an average-sized penis.

Tactile Pump (700 CX Series) - AMS

“The AMS 700 CX Series with the Tactile Pump remains my prosthesis of choice for the older patient where pump concealment is not an issue,” says Dr. Eid. “This pump is large, easily palpable, remains the softest to inflate and has a very large deflation footprint, which is quickly recognized by the patient.” The Tactile pump is not available with the LGX cylinders.

Titan Pump - Coloplast

The FDA approved the improvements to the pump component of the Coloplast Titan prosthesis in July 2008. Although the cylinders and reservoir remain the same as the previous model, the pump now features a one-touch-release (OTR) deflation valve — easy for patients to locate and operable with one hand. In addition, the pump offers a non-bulky, low-profile size; enhanced silicone for higher threshold “tear strength” (likely to result in increased product durability, an issue with previous versions); and an overall simplicity likely to decrease repeat office visits, phone calls, and repeat training time. From a hospital standpoint, intraoperative prep of the device provides for easier priming of the implant system (the removal of excess air prior to filling) and may reduce slightly the overall intraoperative time.

“This remains a great device for the patient with a larger penis,” says Dr. Eid, “as these are the only cylinders that will expand to 22mm girth.” In addition, only Titan cylinders are available in lengths of 24cm, 26cm and 28cm.

Although the pump is easily identified and operated by patients, the small size of the deflation valve sometimes requires a longer learning curve.

In a recent study (”Evaluation of Three Penile Prosthesis Pump Designs in a Blinded Survey of Practitioners,” Urologic Nursing, 2008), 32 medical professionals, all familiar in teaching the operation of penile implants to patients, reviewed currently available penile pumps. The blindfolded reviewers, examining the pumps under time constraints through mock scrotal sacs, were asked to rate device:

– ease of location of deflation valve
– ease of inflation
– ease of deflation, and
– anticipated ability to train patients in clinical setting.

The Titan OTR pump design performed very well and “consistently demonstrated a significant advantage in subject preference.” (Quallich, Ohl & Dunn, 2008, p. 5).

Artificial Urinary Sphincter - AMS

AMS has improved the AUS by coating the device surface with inhibizone. This is the same antibiotic coating (Rifampin and Minocin) currently available on the IPP that has dramatically reduced infection rates since its introduction in 2001. In combination with Dr. Eid’s self-developed “no-touch” surgical technique, which eliminates direct and indirect contact between the prosthesis and the patient’s skin (the origin of most infections), he believes the new coating will offer additional protection against the most common pathogens responsible for sphincter infections.

Dedicated to Patient Education

Dr. Eid has developed a website http://www.UrologicalCare.com dispelling common misconceptions about penile implant surgery. Having performed over 3,000 penile implant surgeries (the most worldwide), Dr. Eid knows what a remarkable and positive difference the treatment can make in a man’s life. Between retaining a normal penis look and feel, employment of multiple techniques for preventing infection, and steady diminishment of pain until it is completely gone within 2-4 weeks, penile implant surgery has proven to be an effective treatment for many men, resulting in normal, healthy and productive lives.

About J. Francois Eid, M.D, and UrologicalCare.com

Dr. Eid is the director and founder of Advanced Urological Care in New York City. He is also a Clinical Associate Professor of Urology at Cornell University. Dr. Eid is one of the foremost specialists in urological prosthetic reconstruction and performs over 300 internal penile implants per year. Dr. Eid leads workshops on penile prosthesis surgeries worldwide. More information about Dr. Eid and his expertise with erectile dysfunction treatment, penile prosthesis implantations and artificial urinary sphincters can be found on his website, http://www.UrologicalCare.com.

UrologicalCare.com

Rexahn Pharmaceuticals, Inc. (NYSE Alternext US: RNN), a leader in development of innovative therapeutics for life-threatening and life-debilitating diseases, announced the completion of enrollment in its Phase IIa clinical trial evaluating ZoraxelTM for treatment of Erectile Dysfunction (ED). The Company expects to have preliminary study results in March 2009.

Zoraxel is being developed as an orally administered tablet for on-demand use, and is one of three compounds being developed by Rexahn as a part of the Company’s clinical stage drug pipeline. In addition to lacking the common side effects associated with many popular ED treatments, Zoraxel has also been shown to significantly improve sexual arousal, erection, and release in disease model studies.

Dr. Chang H. Ahn, Chairman and CEO of Rexahn commented, “It has been our stated goal to move our three highly-marketable compounds successfully through the clinical trial process, and the completion of patient enrollment in the Zoraxel trial represents another steady step in the right direction for Rexahn. This milestone is especially meaningful to us, as we have long believed that our ED compound is a safer and more effective alternative to currently marketed drugs for ED. We look forward to examining and sharing the preliminary data with our shareholders and stakeholders in the near future.”

The Zoraxel Phase IIa trial is a double blind, placebo-controlled, dose ranging study conducted at three U.S. study sites in up to 40 male subjects ages 18 to 65 with ED for six months. Main study endpoints for the 8-week treatment period were the Sexual Encounter Profile (SEP) and the International Index of Erectile Function (IIEF), both of which are validated surveys for assessing erectile function. Planning is underway for initiation of Phase IIb clinical studies.

About ZoraxelTM

ZoraxelTM is being developed as an orally administered, on-demand tablet. It has a well established and excellent safety record in humans and appears to lack severe side effects associated with standard of care phosphodiesterase (PDE-5) inhibitor ED drugs, such as priapism, severe hypotension, myocardial infarction, sudden death, increased intraocular pressure and sudden hearing loss. ZoraxelTM is a centrally acting, dual enhancer of neurotransmitters in the brain, whereas PDE-5 inhibitors only target end organ erectile function and work in peripheral blood vessels. In preclinical animal models, ZoraxelTM has significantly improved all three functions of sexual activity, i.e. sexual arousal, erection, and release, and may be a more effective ED treatment for patients who are responsive or unresponsive to PDE-5 inhibitors.

About Erectile Dysfunction (ED)

ED is defined as the consistent inability to attain and maintain an erection sufficient for satisfactory sexual intercourse. ED affects up to 30 million estimated men in the United States, with 52% of men between the ages of 40 and 70 reporting difficulty with erectile function. By the year 2025, it is estimated that 322 million men worldwide will suffer from some degree of sexual dysfunction.

About Rexahn Pharmaceuticals, Inc.

Rexahn Pharmaceuticals is a clinical stage pharmaceutical company dedicated to commercializing first in class and market leading therapeutics for cancer, CNS disorders, sexual dysfunction and other unmet medical needs. For more information please visit http://www.rexahn.com

Safe Harbor

This press release contains forward-looking statements. Rexahn’s actual results may differ materially from anticipated results, and expectations expressed in these forward-looking statements, as a result of certain risks and uncertainties, including Rexahn’s lack of profitability, its auditor’s going concern qualification and the need for additional capital to operate its business to develop its product candidates; the risk that Rexahn’s development efforts relating to its product candidates may not be successful; the possibility of being unable to obtain regulatory approval of Rexahn’s product candidates; the risk that the results of clinical trials may not be completed on time or support Rexahn’s claims; demand for and market acceptance of Rexahn’s drug candidates; Rexahn’s reliance on third party researchers and manufacturers to develop its product candidates; Rexahn’s ability to develop and obtain protection of its intellectual property; and other risk factors set forth from time to time in our filings with the Securities and Exchange Commission. Rexahn assumes no obligation to update these forward-looking statements.

Rexahn Pharmaceuticals, Inc.

Dr. J. Francois Eid has
performed more internal penile implant surgeries than anyone in the
world and has built a reputation for excellence in the treatment of
erectile dysfunction (ED). After examining the latest generation of
Inflatable Penile Prosthesis (IPP) and Artificial Urinary Sphincter
(AUS) technologies from American Medical Systems (AMS) and Coloplast
Corporation, reviewing pertinent studies, and drawing on his 20 years
of experience performing penile prosthesis surgery and overseeing his
patients’ recuperation and subsequent training in operating the
devices, Dr. Eid has high praise for the recent improvements. Updates
have been made to the IPP pumps offered by both AMS and Coloplast, as
well as to the CX and LGX cylinders offered by AMS. Also, AMS has
added an antibiotic coating to its AUS.

Momentary Squeeze (MS) Pump - AMS

AMS’s Momentary Squeeze (MS) Pump was first introduced nearly two
years ago, and Dr. Eid has implanted it with great success in patients
suited to the CX-cylinder and LGX-cylinder versions. (The LGX model
offers the potential for increased penile length in patients
complaining of penile shortening after radical prostatectomy.) Both
cylinders now feature redesigned proximal ends. At only 9.5mm in
diameter, the ends allow for significantly easier insertion for
patients with fibrotic proximal corporal bodies.

The MS Pump’s advantages include a smaller profile (which enables a
more discreet placement) and one-touch deflation. However, this
quality can result in operational difficulties with inflation (more
difficult to get a hold of within the scrotum) and deflation (small
button can initially be difficult to find). In addition, its new
lockout valve has the advantage of preventing auto-inflation
(potentially embarrassing and/or painful), but can at times make it
difficult to initiate inflation. For these reasons, Dr. Eid
recommends this pump for the younger patient with an average-sized
penis.

Tactile Pump (700 CX Series) - AMS

“The AMS 700 CX Series with the Tactile Pump remains my prosthesis of
choice for the older patient where pump concealment is not an issue,”
says Dr. Eid. “This pump is large, easily palpable, remains the
softest to inflate and has a very large deflation footprint, which is
quickly recognized by the patient.” The Tactile pump is not available
with the LGX cylinders.

Titan Pump - Coloplast

The FDA approved the improvements to the pump component of the
Coloplast Titan prosthesis in July 2008. Although the cylinders and
reservoir remain the same as the previous model, the pump now
features a one-touch-release (OTR) deflation valve — easy for
patients to locate and operable with one hand. In addition, the pump
offers a non-bulky, low-profile size; enhanced silicone for higher
threshold “tear strength” (likely to result in increased product
durability, an issue with previous versions); and an overall
simplicity likely to decrease repeat office visits, phone calls, and
repeat training time. From a hospital standpoint, intraoperative
prep of the device provides for easier priming of the implant system
(the removal of excess air prior to filling) and may reduce slightly
the overall intraoperative time.

“This remains a great device for the patient with a larger penis,”
says Dr. Eid, “as these are the only cylinders that will expand to
22mm girth.” In addition, only Titan cylinders are available in
lengths of 24cm, 26cm and 28cm.

Although the pump is easily identified and operated by patients, the
small size of the deflation valve sometimes requires a longer learning
curve.

In a recent study (”Evaluation of Three Penile Prosthesis Pump
Designs in a Blinded Survey of Practitioners,” Urologic Nursing,
2008), 32 medical professionals, all familiar in teaching the
operation of penile implants to patients, reviewed currently
available penile pumps. The blindfolded reviewers, examining the
pumps under time constraints through mock scrotal sacs, were asked to
rate device:

— ease of location of deflation valve
— ease of inflation
— ease of deflation, and
— anticipated ability to train patients in clinical setting.

The Titan OTR pump design performed very well and “consistently
demonstrated a significant advantage in subject preference.”
(Quallich, Ohl & Dunn, 2008, p. 5).

Artificial Urinary Sphincter - AMS

AMS has improved the AUS by coating the device surface with
inhibizone. This is the same antibiotic coating (Rifampin and Minocin)
currently available on the IPP that has dramatically reduced infection
rates since its introduction in 2001. In combination with Dr. Eid’s
self-developed “no-touch” surgical technique, which eliminates direct
and indirect contact between the prosthesis and the patient’s skin
(the origin of most infections), he believes the new coating will
offer additional protection against the most common pathogens
responsible for sphincter infections.

Dedicated to Patient Education

Dr. Eid has developed a website http://www.urologicalcare.com
dispelling common misconceptions about penile implant surgery. Having
performed over 3,000 penile implant surgeries (the most worldwide),
Dr. Eid knows what a remarkable and positive difference the treatment
can make in a man’s life. Between retaining a normal penis look and
feel, employment of multiple techniques for preventing infection, and
steady diminishment of pain until it is completely gone within 2-4
weeks, penile implant surgery has proven to be an effective treatment
for many men, resulting in normal, healthy and productive lives.

About J. Francois Eid, M.D, and urologicalcare.com

Dr. Eid is the director and founder of Advanced Urological Care in
New York City. He is also a Clinical Associate Professor of Urology
at Cornell University. Dr. Eid is one of the foremost specialists in
urological prosthetic reconstruction and performs over 300 internal
penile implants per year. Dr. Eid leads workshops on penile
prosthesis surgeries worldwide. More information about Dr. Eid and
his expertise with erectile dysfunction treatment, penile prosthesis
implantations and artificial urinary sphincters can be found on his
website, http://www.urologicalcare.com.

Urologicalcare.com

Men who experience erectile dysfunction between the ages of 40 and 49 are twice as likely to develop heart disease than men without dysfunction, according to a new Mayo Clinic study.

Researchers also found that men with erectile dysfunction have an 80 percent higher risk of heart disease.

“The highest risk for coronary heart disease was in younger men,” says researcher Jennifer St. Sauver, Ph.D. The study was published in the February 2009 issue of Mayo Clinic Proceedings. The results suggest that younger men and their doctors may need to consider erectile dysfunction a harbinger of future risk of coronary heart disease — and take appropriate steps to prevent it, says Dr. St. Sauver.

“The importance of the study cannot be overstated,” writes Martin Miner, M.D., in an editorial in the same issue of Mayo Clinic Proceedings. The results “raise the possibility of a ‘window of curability,’ in which progression of cardiac disease might be slowed or halted by medical intervention,” writes Dr. Miner, who practices at the Men’s Health Center, Miriam Hospital, Providence, R.I.

Erectile dysfunction is common, and prevalence increases with age. It affects 5 to 10 percent of men at age 40. By age 70, from 40 to 60 percent of men have the condition.

Dr. St. Sauver says researchers wanted to learn more about the connections between age, cardiovascular disease and erectile dysfunction. Two previous studies, both published in 2005, laid groundwork for the Mayo Clinic study. One found that erectile dysfunction predicted an increased risk of heart disease, but the erectile dysfunction of the study participants was not assessed with an externally validated questionnaire and cardiac events were not subjected to standardized review for diagnostic accuracy [Thompson et al, JAMA, 2005]. The second predicted that future cardiovascular disease would be higher in younger men with erectile dysfunction, but wasn’t able to follow the men to determine if heart disease developed [Ponholzer et al, Eur Urol, 2005].

For the Mayo Clinic study, the investigators identified 1,402 men who lived in Olmsted County, Minn., in 1996 and did not have heart disease. Every two years for 10 years, these men were assessed for urological and sexual health.

Answers to questions from the Brief Male Sexual Function Inventory, a statistically validated questionnaire, were used to determine erectile dysfunction. The baseline prevalence of erectile dysfunction in study participants was: 2.4 percent in men aged 40-49; 5.6 percent in men aged 50-59; 17 percent in men aged 60-69 and 38.8 percent in men 70 years and older. Those initial data and the increasing incidence of erectile dysfunction over time were linked to data from a long-term study of heart disease in Olmsted County residents, led by Veronique Roger, M.D., Mayo Clinic cardiologist.

Over 10 years of follow-up, researchers found that men with erectile dysfunction were 80 percent more likely to develop coronary heart disease compared to men without erectile dysfunction. The highest risk of new heart disease was seen in the youngest study participants who had erectile dysfunction. In men 40 to 49 years old when the study began, the number of new cases in men with erectile dysfunction was more than 50-fold higher than in men without erectile dysfunction. Statistically, that’s a cumulative incidence of 48.52 per 1,000 person years in those with erectile dysfunction compared to 0.94 per 1,000 person years in those without erectile dysfunction.

In men in their 50s, 60s and 70s, the total incidence of new cases of heart disease also was higher in those with erectile dysfunction. However, the differences were not as striking as those seen among the 40- to 49-year- olds.

“In older men, erectile dysfunction may be of less prognostic importance for development of future heart disease,” says Dr. St. Sauver.

This study did not determine reasons for the increased risk of heart disease among men with erectile dysfunction. Some have theorized that erectile dysfunction and coronary artery disease may be different manifestations of the same underlying disease process. A buildup of plaque that can block arteries around the heart may plug the smaller penile arteries first, causing erectile dysfunction. Alternatively, arteries may lose elasticity over time, contributing to heart disease. This arterial stiffening may affect the smaller penile arteries first.

Other Mayo Clinic researchers were: Brant Inman, M.D.; Debra Jacobson; Michaela Mc Gree; Ajay Nehra, M.D.; Michael Lieber, M.D.; Dr. Roger; and Steven Jacobsen, M.D., Ph.D.

A peer-review journal, Mayo Clinic Proceedings publishes original articles and reviews dealing with clinical and laboratory medicine, clinical research, basic science research and clinical epidemiology. Mayo Clinic Proceedings is published monthly by Mayo Foundation for Medical Education and Research as part of its commitment to the medical education of physicians. The journal has been published for more than 80 years and has a circulation of 130,000 nationally and internationally. Articles are available online at http://www.mayoclinicproceedings.com.

To obtain the latest news releases from Mayo Clinic, go to http://www.mayoclinic.org/news. MayoClinic.com (http://www.mayoclinic.com) is available as a resource for your health stories.

Mayo Clinic
http://www.mayoclinic.com

A new robotic surgical technique developed at The Cancer Institute of New Jersey (CINJ) for the removal of all or part of the prostate gland is showing what investigators call a “dramatic improvement” in a male’s sexual potency rate. The results were recently presented at the 26th World Congress Endourology meeting in Shanghai, China. CINJ is a Center of Excellence of UMDNJ-Robert Wood Johnson Medical School and has also developed a Center of Excellence for robotic surgery.

Robotic prostatectomy allows a surgeon to control a set of robotic arms that holds the surgical instruments in order to remove prostate cancer through several incisions that are smaller than a quarter. It allows for additional precision, reduced blood loss, shorter hospital stays and faster recovery for the patient. Isaac Kim, MD, PhD, who is the director of CINJ’s Urologic Oncology Program and assistant professor of surgery at UMDNJ-Robert Wood Johnson Medical School, found a way to enhance the procedure, by developing a new technique known as Athermal Intrafascial Robotic (AIR) prostatectomy.

In AIR prostatectomy, the nerve that controls a man’s ability to have an erection is better preserved by sparing over 90 percent of the tissues that surrounds the prostate. In the conventional open or robotic radical prostatectomy, typically only 40 to 50 percent of the tissue around the prostate is spared. Additional tissues that are located at the top of the prostate are nearly impossible to spare during an open prostatectomy due to the presence of a major vein called the dorsal venous complex.

Typically with the conventional method, the sexual potency rate is between 65 and 75 percent at one year following the surgery. With the AIR procedure, investigators at CINJ found the potency level was at 91 percent nine months post surgery. At the nine-month mark for the conventional robotic method, the potency rate was only 67 percent.

Dr. Kim, who has performed more than 450 robotic prostatectomies over the past four years at CINJ’s Flagship hospital, Robert Wood Johnson University Hospital in New Brunswick, notes the results are significant, “Not only does the AIR procedure help men regain sexual function in a quicker fashion, but it also helps them to regain control over their bladder faster as well as reducing incontinence.”

At six months, the continence rate (defined as requiring no protective pads) following the AIR procedure was 93 percent.

About The Cancer Institute of New Jersey

The Cancer Institute of New Jersey is the state’s first and only National Cancer Institute-designated Comprehensive Cancer Center, and is dedicated to improving the prevention, detection, treatment and care of patients with cancer. CINJ’s physician-scientists engage in translational research, transforming their laboratory discoveries into clinical practice quite literally bringing research to life. The Cancer Institute of New Jersey is a center of excellence of UMDNJ-Robert Wood Johnson Medical School. To support CINJ, please call the Cancer Institute of New Jersey Foundation at 1-888-333-CINJ.

The Cancer Institute of New Jersey Network is comprised of hospitals throughout the state and provides a mechanism to rapidly disseminate important discoveries into the community. Flagship Hospital: Robert Wood Johnson University Hospital. Affiliate Hospitals: Bayshore Community Hospital, Carol G. Simon Cancer Center at Morristown Memorial Hospital, Carol G. Simon Cancer Center at Overlook Hospital, CentraState Healthcare System, Cooper University Hospital*, Jersey Shore University Medical Center, JFK Medical Center, Raritan Bay Medical Center, Robert Wood Johnson University Hospital at Hamilton (CINJ at Hamilton), Saint Peter’s University Hospital, Somerset Medical Center, Southern Ocean County Hospital, The University Hospital/UMDNJ-New Jersey Medical School*, and University Medical Center at Princeton. *Academic Affiliate

Michele Fisher
Media Relations Specialist
Office of Communications
The Cancer Institute of New Jersey
195 Little Albany Street
New Brunswick, NJ 08903
http://www.cinj.org

The conversation about male sexual dysfunction has grown from a whisper to a roar. From Bob Dole to Mike Ditka, erectile dysfunction, or ED, is no longer hush-hush as more men are talking more openly. Non-stop commercials convey help in the bedroom is just a prescription away. And while some 35 million men in this country have found a renewed sex life thanks to the “little blue pill,” Temple urologist Jack Mydlo says men can improve their performance without a visit to the doctor or a drugstore.

“The last thing I want them to do is take a pill and jump in bed because a certain part of the mechanism for erections is psychological. They have to be in the right mood, with the right person and take care of themselves” said Mydlo, MD, professor and chair of the department of urology at the School of Medicine.

Surprisingly, a good percentage of men who seek medical help aren’t even in a relationship.

“About thirty percent of the men who have a penile prosthesis don’t even have a partner,” said Mydlo. “They’re putting the cart before the horse, so to speak, and think they’ll get a partner once they have the implant.

Instead, Mydlo offers simple tips this Valentine’s Day to turn a man’s potency from terrible to terrific.

Stop smoking

Diabetes and high blood pressure restrict blood flow to the penis, leading to erectile dysfunction. But if you can rule those conditions out as causes of ED, the next culprit in line is cigarettes. “The number one thing we can do to stop erectile dysfunction is to stop smoking. It’s the number one environmental cause of ED in our society,” says Mydlo. Again, smoking restricts blood flow. The catch? Don’t expect better erections the minute you stop lighting up. He says it takes 12 to 24 months for better function once you quit the habit.

Control cholesterol

Cholesterol is a trigger of sorts for ED. “Men with a cholesterol level of 240 or higher have almost a twofold increase of ED compared to a man who has lower cholesterol numbers,” says Mydlo. That’s because high levels of cholesterol lead to plaque buildup in tubes (corpa cavernosa) in the penis and arteries, which can greatly reduce blood flow. And no blood flow means no erection. So start exercising and check with your doctor about cholesterol-lowering medications.

Cut back on fat

Obesity is to blame not only for men with self-esteem issues involving their appearance, but also their performance. “Adipose tissue in body fat converts testosterone to estrogen, and lower levels of testosterone can make it difficult for a man to achieve an erection, no matter how many pills they take,” says Mydlo. Losing weight will improve the testosterone to estrogen ratio, which may improve sex drive, or libido, as well as erections. It also decreases cholesterol, which will help improve blood flow.

For some of the 18 million men who have erectile dysfunction, these three tips may do the trick. For others, Mydlo suggests a visit to a urologist to go over options, ranging from pumps to implants to pills, like Viagra. Cialis Levitra (vardenafil). Levitra There is one factor, though, that Mydlo can’t help with but Cupid probably can: finding the right mate.

“They believe if they don’t have good sexual function, who is going to want them? But the truth is, if you don’t have a mental connection with your partner, everything will be for naught.”

Temple University
301 University Services Bldg.1601 N Broad St.
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VIVUS, Inc. (NASDAQ: VVUS), a pharmaceutical company dedicated to the development and commercialization of novel therapeutic products, today announced it has initiated a second pivotal Phase 3 study of avanafil, its investigational new drug for the treatment of erectile dysfunction (ED). Avanafil is a next-generation, fast-acting, selective, investigational oral phosphodiesterase type 5 (PDE5) inhibitor.

The study, REVIVE-Diabetes (TA-302), is a multicenter, randomized, double-blind, placebo-controlled trial and will evaluate the safety and efficacy of avanafil in the treatment of ED in men with type 1 or type 2 diabetes. Subjects who meet the inclusion criteria will undergo a four-week non-treatment run-in period followed by 12 weeks of treatment. The co-primary endpoints of the study will be improvement in erectile function as measured by changes in the sexual encounter profile (SEP) questions 2 and 3, and improvement in erectile function as measured by the erectile function domain score of the International Index of Erectile Function (IIEF). The SEP is a self-administered patient diary and the IIEF is a patient questionnaire; both are used as standard diagnostic tools to assess erectile dysfunction. REVIVE-Diabetes is the second of three planned pivotal studies in the avanafil Phase 3 development program.

“There has not been a new treatment option for men with ED in more than five years,” stated Andrew McCullough, MD, associate professor of clinical urology, NYU School of Medicine and REVIVE-Diabetes clinical investigator. Early data suggest that avanafil may provide a fast-acting therapy with a short half-life, which, if approved, may represent a noteworthy advance for the millions of men living with ED and searching for new options.”

Diabetes is one of the most common causes of ED; clinical data suggest that at least 50 percent of diabetic men will experience difficulties with erectile function. Men with diabetes are up to three times more likely to have ED than non-diabetic men and appear to experience it earlier in life. The significance of ED increases with the severity and duration of diabetes as well as with advanced age.

“Evidence suggests that there is room for significant improvement in the current treatment of ED,” Charles Bowden, MD, senior director, clinical development for VIVUS. “We’re pleased with the promising results demonstrated thus far with avanafil, and with the momentum behind our Phase 3 program. Enrollment in our first pivotal study, REVIVE, initiated in December to evaluate avanafil in ED, is ongoing. REVIVE-Diabetes will be conducted at many of the same sites as REVIVE.”

It is expected that this study will enroll approximately 375 patients at about 30 sites in the United States. Subjects are instructed to attempt sexual intercourse 30 minutes after taking avanafil, with no restrictions on food or alcohol consumption. REVIVE-Diabetes will study two doses of avanafil. More information about the trial can be found at http://www.clinicaltrials.gov.

As previously disclosed, VIVUS has entered into a $30 million funding collaboration with Deerfield Management to fund the Phase 3 program.

About Erectile Dysfunction

Erectile dysfunction, or ED, the inability to attain or maintain an erection sufficient for intercourse, was reported by 35% of men between the ages of 40 to 70 in the United States, according to an independent study, with the incidence increasing with age. ED, frequently associated with vascular problems, is particularly common in men with diabetes and in those who have had a radical prostatectomy for prostate cancer. PDE5 inhibitors, which inhibit the breakdown of cyclic guanosine monophosphate, have been shown to be effective treatments for ED.

Worldwide sales in 2008 of PDE5 inhibitor products for ED were estimated, based on reports from the companies that market these products, to be in excess of $3.7 billion, including approximately $1.9 billion in reported sales of Viagra, approximately $1.5 billion in reported sales of Cialis and approximately $300 million in reported sales of Levitra. VIVUS believes that based on the aging baby boomer population and the desire to maintain an active sexual lifestyle, the market for PDE5 inhibitors will continue to grow.

Avanafil Phase 2 Data

VIVUS previously reported positive results from the Phase 2 studies of avanafil. Following a four-week, non-treatment, run-in period, 284 patients were treated for 12 weeks with placebo or avanafil at various doses. The primary endpoints used to assess treatment efficacy included the percentage of erections sufficient for vaginal penetration and the percentage of erections lasting long enough for successful intercourse. Avanafil produced erections sufficient for vaginal penetration on 76, 79, 80 and 84 percent of sexual attempts on the 50, 100, 200 and 300 mg doses, respectively (p<0.05). Erections lasting long enough for successful intercourse were achieved on 54, 59, 62 and 64 percent of attempts, respectively (p<0.0001). Patients were instructed to attempt sexual intercourse 30 minutes after taking avanafil, with no restrictions on food or alcohol consumption. Avanafil was well tolerated at all doses, with headache being the most commonly recorded adverse event. There were no reports of visual disturbances. Previous studies have suggested that avanafil may be taken twice a day for those patients that desire sexual intercourse more frequently than once per day.

About VIVUS

VIVUS is a biopharmaceutical company developing innovative, next-generation therapies to address unmet needs in obesity, diabetes and sexual health. The company’s lead product in clinical development, Qnexa™, is expected to complete Phase 3 clinical trials for the treatment of obesity in 2009. Qnexa is also in Phase 2 clinical development for the treatment of type 2 diabetes. In the area of sexual health, VIVUS is in Phase 3 development with avanafil, a potentially best-in-class PDE5 inhibitor, and in Phase 2 development of Luramist™ for the treatment of hypoactive sexual desire disorder (HSDD) in women. MUSE® (alprostadil), a first generation therapy for the treatment of ED, is already on the market and generating revenue for VIVUS. For more information about the company, please visit http://www.vivus.com.

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend,” among others. These forward-looking statements are based on VIVUS’ current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; uncertainties of patent protection and litigation; uncertainties of government or third party payer reimbursement; reliance on sole source suppliers; limited sales and marketing efforts and dependence upon third parties; risks related to the development of innovative products; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that future clinical studies discussed in this press release will be completed or successful or that any product will receive regulatory approval for any indication or prove to be commercially successful. VIVUS does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in VIVUS’ Form 10-K for the year ended December 31, 2007 and periodic reports filed with the Securities and Exchange Commission

VIVUS

Pfizer’s inaugural Asia Pacific Sexual Health and Overall Wellness (AP SHOW) survey has uncovered staggering levels of sexual dissatisfaction, with 60% of men and around 60% of women in Australia saying they are not very satisfied with their sex lives.

Erectile Dysfunction (ED) continues to be a key cause of dissatisfaction. The AP SHOW survey, conducted in 13 Asia Pacific nations, found that men with ’suboptimal erections’, (erections that are not as hard as they could be) are less satisfied with sex and other aspects of the sexual experience.

There is also evidence of an association between optimal erectile function and men’s and women’s overall outlook on life, attitudes about sex and men’s sexual health and performance.

54% of men with optimal erectile function say that it is ‘very true’ that they feel good about their relationships compared to 47% of men with suboptimal erections. Among women, this difference is significantly more pronounced - 65% of women whose partners have optimal erection function say that it is ‘very true’ that they feel good about their relationships, compared to only 32% of women whose partners have suboptimal erections.

The survey also found that men and women who are ‘completely’ or ‘very satisfied’ with sex are more than three times more likely to feel good about their relationships and life overall compared to those who are only ’somewhat’ or ‘not at all satisfied’ with sex.

It is an area where GPs can make a significant difference, yet as few as 30% of men with ED seek help from their doctor. [i]

Dr Rosie King, Sexual Health Physician, Sydney Centre for Sexual and Relationship Therapy, Sydney, Australia said, “A person’s willingness to talk about sexual health and performance is heavily influenced by diverse cultural beliefs and practices - most patients and even doctors are uncomfortable initiating such discussions. Therefore, a great many people remain untreated.”

“GPs are aware of the importance of erectile function to the overall health and wellbeing of male patients and their partners. So, overcoming communication barriers about sexual health is crucially important,” said Dr King. “The more physicians discuss sexual problems, the more comfortable they’ll be.”

“If a GP suspects a patient may have erection problems, there are sensitive ways to broach the subject. GPs can also help patients know that they are willing to discuss these issues even before they enter the consulting room by creating an open practice environment.”

This might include placing brochures on sexual health and ED in the waiting room, offering a questionnaire that patients can fill out while waiting for their consultation or displaying posters in the waiting area and examination rooms to indicate a GPs interest in the sexual wellbeing of their patients.

“When talking about sexual health topics with patients, it is extremely important to establish a rapport that enables an open discussion. During such discussions, it is important to communicate several key points to a patient with suboptimal sexual performance including:

- GPs do treat sexual health and that sexual health is an important part of general health. Satisfactory sexual health and performance is associated with emotional wellbeing and overall good health.

- Suboptimal erections are a common problem, affecting more than 50% of men aged 40 to 70 years [ii].

- Erection problems and suboptimal erections are not a normal part of aging. An older male has just as much right to normal sexual functioning as younger men.

- Suboptimal erections can be due to an underlying illness or medication, and is not always due to psychological factors alone. Suboptimal erections often have a mixed aetiology, both organic and psychological. Concomitant physical disease is an important cause of suboptimal erections.

- Effective and convenient treatments are available and international medical consensus has affirmed that in suitable patients with suboptimal erections or ED, oral medications should be the first-line treatment. [iii]

Notes

- Data from 3,957 sexually active men and women (2,016 males and 1,941 females), from the general public, was gathered for this survey1 This included 101 males and 108 females surveyed nationwide in Australia.

- The AP SHOW survey respondents were aged between 25-74 years and had had sexual intercourse at least once in the past 12 months, (female respondents had to have sex with a member of the opposite sex)

- The 13 Asian countries/regions surveyed included Australia, China, Hong Kong, India, Indonesia, Japan, Malaysia, the Philippines, Singapore, South Korea, Taiwan, Thailand, and New Zealand

- Face-to-face interviews (a self completed questionnaire), were conducted in China, India, and Thailand
- An online self-administered method was used in Australia, Hong Kong, Indonesia, Japan, Malaysia, the Philippines, Singapore, South Korea, Taiwan, and New Zealand

- The AP SHOW survey was conducted from May to July 2008, by Harris Interactive, an independent market research company, and was sponsored by a non-restricted, educational grant from Pfizer Global Pharmaceuticals

References:
1 Data on file, Pfizer Global Pharmaceuticals.

About Pfizer Australia

Pfizer Australia is the nation’s leading research-based health care company, investing over $A50m in local research and development annually. It develops, manufactures and markets innovative medicines for both humans and animals. For more information visit http://www.pfizeraustralia.com.au

Source
Amy O’Hara
Media Communications Assistant
Public Affairs & Policy
Pfizer Australia
http://www.pfizeraustralia.com.au