Entries in Erectile Dysfunction (7)


Diabetic Sues Doctor After Penis Amputation

Jupiterimages/Thinkstock(MIAMI) -- A man who elected to have a penile implant in a Florida hospital is now suing his doctor after a post-surgical infection resulted in the amputation of his organ.

Enrique Milla, 65, who was reportedly deported from the United States last year back to his native Peru, has been testifying in court via Skype that the medical procedure robbed him of his dignity and manhood.

In a medical malpractice trial that began this week, Milla claims that his doctors should have known that he was not a good candidate for the procedure because of his diabetes and high blood pressure.

"This has been devastating, painful and embarrassing," said Milla's attorney, Spencer Aronfeld of Coral Gables, according to ABC's affiliate WPLG.

Milla alleges that his anesthesiologist Dr. Laurentiu Boeru "failed to evaluate properly the risks of this procedure." He first filed the lawsuit in 2009, naming Boeru and Dr. Paul Perito, the urologist who performed the surgery.

According to the Miami Herald, which obtained records that are not publicly available, Perito settled the case out of court.

Penile implant surgery is most commonly performed after all other treatments for erectile dysfunction have failed. It is also used to treat some cases of Peyronie's disease, a condition that causes scarring inside the penis, leading to bent, painful erections.

Implant surgery comes with a risk of infection, which can occur at any time after surgery -- in rare cases, even years later, according to the Mayo Clinic.

Milla suffered from a number of medical conditions, including erectile dysfunction, according to court records. Milla, who had lived in Miami for 40 years working in a medical supply business, received the surgery in 2007 at Coral Gables Hospital. But two weeks after the operation, Milla developed an infection that eventually turned to gangrene. Amputation of his penis was necessary to save his life, according to his lawyer, who alleges Boeru didn't exercise proper care after the surgery.

"Post-operative period is about anywhere between six to 24 hours after surgery. It does not include either days or months," testified Boeru.

"This is an infection that occurred in this gentleman because he didn't do what he was supposed to do post-operatively nine days after the surgery," Boeru's lawyer Jay Chimpoulis, told WPLG.

He suggested that Milla ignored medical instructions to avoid sex and developed a fecal infection.

"There are any number of ways he could've gotten that. None of them had anything to do with [Boeru]," Chimpoulis said.

Dr. Pravin Rao, director of reproductive medicine and surgery at the Johns Hopkins Brady Urological Institute, said penile implants, called prostheses, are safe for patients who are in good health -- even those with diabetes, as long as the disease is "controlled." The risk rate is lower than three percent, according to Rao, who did not treat Milla.

Penile implants are among a "long algorithm of options" for those with erectile dysfunction, according to Rao. Urologists start with pills like Viagra -- the least invasive approach -- to vacuum erection devices and injection therapy. But sometimes those treatments fail because of the quality of the tissue in the penis or poor blood flow. The most common reason for ED is chronic disease that affects the vessels in the penis -- most often diabetes, hypertension, smoking or high cholesterol. Nerve damage, caused by spinal cord injuries, diabetes or radical prostate cancer surgery, can also trigger ED.

A poor candidate for a prosthesis is someone who is not in overall good health and may be at risk under anesthesia or not be able to withstand the blood loss of surgery.

"The number-one concern is infection, and that's why we make sure their overall health and immune status are good and their diabetes is under control," said Rao.

When infection does occur, the prosthesis must be immediately removed to clear the infection.

The prosthesis is an inflatable device that is inserted in the two tubes of the penis. The balloons can be filled up with fluid, creating an erection. A small pump is placed in the scrotum with a reservoir of fluid that connects to the tubing.

"When we first place it, we don't have it activated to create a full erection," said Rao. "Then after letting it heal for six weeks, [the patient] comes in and we teach them how to use the pump by squeezing it."

Patients are told not to have sex during that recuperative period.

Rao said that penile implants are "very successful and infection is not the norm."

Some studies of patients with diabetes and those without the disease had the same rate of infection. "But," he said, "we have to be prudent about picking the patient."
Copyright 2012 ABC News Radio


FDA Approves New Drug for Erectile Dysfunction

Jupiterimages/Thinkstock(WASHINGTON) -- The Food and Drug Administration on Friday approved Stendra, a new pill in the same drug class as Viagra, Levitra and Cialis, which reportedly offers men with erectile dysfunction the possibility of achieving an erection in as little as 15 minutes.

Stendra, the brand name for avanafil, will be available in three doses: 50, 100 or 200 milligrams, and should be prescribed at the lowest dose that provides a benefit, the FDA said. In clinical trials reviewed by the agency, participants reported “statistically significant” improvements in erectile function, vaginal penetration and successful intercourse with all three Stendra doses.

Friday’s FDA action marks the first drug  approval for Vivus Inc., of Mountain View, Calif., which licensed U.S. marketing rights to avanafil from Mitsubishi Tanabe Pharma Corp. of Japan. Vivus is the biopharmaceutical company behind the diet drug Qnexa, which remains under FDA review.

An estimated 30 million U.S. men have some degree of what used to be called impotence. With the arrival of Viagra, the little blue pill destigmatized the condition and gave it a new name: erectile dysfunction, or ED.

“This approval expands the available treatment options to men experiencing erectile dysfunction, and enables patients, in consultation with their doctor, to choose the most appropriate treatment for their needs,” said Dr. Victor Kusiak,  a deputy director within the FDA’s Center for Drug Evaluation and Research.

Stendra is the newest of the phosphodiesterase type 5 (PDE5) inhibitors, which include Viagra (sildenafil), Levitra (vardenafil) and Cialis (tadalafil). All boost blood flow to the penis to help men achieve and sustain an erection. However, Stendra tablets, to be taken 30 minutes before sexual activity, go to work in as little as 15 minutes, according to clinical trial results submitted to the FDA.

The most common side effects of Stendra were headache, flushing, stuffy nose, mild cold symptoms and back pain.

The drug already has been approved for use in South Korea under the brand name Zepeed.

The most recent FDA approval of an ED drug came in 2010 for Staxyn, a version of vardenafil that dissolves under the tongue, rather than being swallowed.

Copyright 2012 ABC News Radio


Avanafil: Do We Need Another Viagra?

Jupiterimages/Thinkstock(NEW YORK) -- The erectile dysfunction marketplace could get its first new entry in almost a decade with the experimental drug Avanafil, a faster-acting pill in the same class as Viagra, Levitra and Cialis, reportedly with fewer side effects.

But do we really need another Viagra?

“No, we don’t need another Viagra, but competition is good. We need to see a reduction in the cost to the consumer of these drugs, and this is not exactly another Viagra,” said Dr. Ira Sharlip, a urology professor at UC San Francisco and former president of the International Society for Sexual Medicine. “I say this because the onset of action seems to be faster than Viagra, although there are no head-to-head studies of onset of action.”

The little blue pill Viagra (sildenafil) started a late 20th century sexual revolution by destigmatizing impotence, and replacing that term with “erectile dysfunction,” or ED in the popular lexicon. Like Viagra and its competitors Levitra (vardenafil) and Cialis (tadalafil), all of which are regularly advertised on television, Avanafil increases blood flow to the penis to help men achieve and sustain an erection. But its main selling point may be that clinical trials suggest it can produce an erection in as little as 15 minutes.

“Quick onset of action is important to men,” especially a subset of patients seeking treatment for erectile dysfunction, Sharlip said.

The studies also indicate Avanafil clears the body more quickly than the other ED drugs in the same class, the phosphodiesterase type 5 (PDE5) inhibitors, according to data submitted to the FDA by Vivus Inc. The pharmaceutical company also is behind the diet drug Qnexa, which remains under FDA review.

In a Phase II study, Avanafil worked as well as Viagra while producing less low blood pressure in cardiac patients who take nitroglycerin. In the two Phase III trials that compared Avanafil with a placebo, there were no reports of blue vision or prolonged, painful erections (priapism), which are infrequent side effects associated with Viagra. In rare cases, men taking any of the PDE5 drugs have reported sudden decreases in hearing or loss of hearing.

Sharlip said he didn’t believe that those rare side effects matter much to most patients. “Despite what the FDA says, I have never seen priapism from any PDE5 inhibitor drug. Priapism is just not a clinical problem. Blue vision with Viagra is uncommon and at worst annoying. Most men who get the blue vision with Viagra don’t care about it,” he said.

The most common side effects of Avanafil in studies to date were headache, flushing, stuffy nose, mild cold symptoms and back pain.

Avanafil has been approved for use in Korea.

The FDA set an April 29 target date for its Avanafil review. Vivus, based in Mountain View, Calif., licensed rights to the drug from Mitsubishi Tanabe Pharma Corp.

The most recent FDA approval of an ED drug came in 2010 for Staxyn, a version of vardenafil that dissolves under the tongue, rather than being swallowed.

Copyright 2012 ABC News Radio


Prostate Cancer Counseling Helps Couples' Sex Lives, Says Study

Jupiterimages/Thinkstock(HOUSTON) -- Despite improved therapies for men diagnosed with prostate cancer, most men face erection dysfunction because of nerve damage or blood flow problems.  Many also lose their desire for sex and have difficulties reaching an orgasm.

Now, a new study published online in Cancer, a peer-reviewed journal of the American Cancer Society, suggests that counseling can enhance the effectiveness of erectile dysfunction medications to help improve couples' sex lives.

Both Internet-based counseling and face-to-face therapy sessions improved the sex lives of prostate cancer survivors and their spouses, according to the study led by Leslie Schover, a psychologist and professor at the University of Texas MD Anderson Cancer Center in Houston.

"When men get these problems, they see their sexual function as how hard is my erection, and women get ignored and turned off," she said.  "And so men get distressed emotionally and feel like they are a failure."

In the study, Internet-based and face-to-face counseling focused on both partners' enjoyment when they "encountered more intimacy and less performance," said Schover.

The University of Texas study involved 115 couples. In each case, the man's prostate cancer treatment had taken place no more than two years prior to the study.  Half of the couples sought no help for three months.  The other half had three face-to-face counseling sessions or worked with an online counselor who gave feedback on the Internet.

A third group of 71 couples who lived too far to participate in face-to-face counseling was part of the Internet group.

Couples were also educated about treatment options for impotence: drugs like Viagra that increase blood flow, shots in the penis, vacuum pumps and surgical penile implants.

Each partner looked over the information on these medical interventions and rated them. The computer generated their top three choices.

Couples compared notes then agreed on a treatment option as a first step.  They were also monitored by counselors to see how well it worked and to "troubleshoot," according to Schover.

After three months, the couples who had received no counseling benefits were assigned one of the two treatment options.

Both partners in the relationship filled out questionnaires assessing their sexual function and satisfaction before counseling, after treatment, and at six months and one year later.

At the end of one year, 54 percent found effective treatments for their sexual dysfunction.  On average, the group "looked like the score of men in a community who don't have erection problems," said Schover.

Copyright 2011 ABC News Radio


Study Links Wife's Interaction with Husband's Friends to Sex Drive

Jupiterimages/Thinkstock(CHICAGO) -- Middle-aged to older men whose wives are closer to their friends than they are themselves are more likely to experience sexual dysfunction, according to a new study by the University of Chicago and Cornell University.

Researchers polled 3,005 men between the ages of 57-85 and found the effect known as "partner betweenness" to be a significant contributor to erectile dysfunction and other sex-related complications. Partner betweenness refers to the dynamic of a relationship in which one partner is closer with their spouse's friends than they are. The study found the phenomenon to have a particularly acute effect on male sex drive, especially in men aged 57-65.

The cause for sexual dysfunction has less to do with jealousy than it does privacy and autonomy. Researchers say when men feel like they lose that connection with their friends to their spouse, it threatens their masculinity.

According to the study, men whose wives are closer confidants to their friends than they are have a 92-percent higher chance of developing sexual dysfunction.

Copyright 2011 ABC News Radio


Honeymoon With Viagra Could Be Over, Say Doctors

John Foxx/Stockbyte/Thinkstock(NEW YORK) -- Sales of the little blue pill that promised men they could be sexually active well into their 70s and 80s are going soft after flying off the shelves for more than a decade.

The market for Viagra-type drugs has stalled in the United States.  Last year the total number of prescriptions for so-called ED drugs declined by five percent after growing just one percent annually the previous four years, according to IMS Health, a heath-care data and consulting firm.  Viagra prescriptions drooped by seven percent; those for Levitra sank 18 percent.

The market for these virility drugs still top $5 billion in annual sales to tens of millions of men.  But for many, who saw the drugs as a powerful aphrodisiac that would cure all the things that were wrong in their lives, the drugs, purported to be some of the safest in the world, just didn't live up to expectations.

"It's not that these drugs don't work. If one doesn't work, all three don't work," said Dr. Thomas Jarrett, head of urology at George Washington University.

Cialus, which has a 24- to 36-hour window of effectiveness -- for when the "moment is right"-- is predicted to outpace the short-acting drugs this year.

Many insurance companies don't cover these so-called "lifestyle drugs," and those that do only pays for four pills a month. Out of pocket, they cost $12 to $15 a tablet, not exactly a cheap thrill.

"We still write a lot of prescriptions, but without any objective evidence, it doesn't seem like we write as many as we used to," said Jarrett.

A poor economy, coupled with market "over-saturation," and even disenchantment among men when more sex didn't improve their lives, may explain why prescriptions are down, he said.

Copyright 2011 ABC News Radio


Use of NSAIDs May Be Linked to Men's Sexual Performance

Jupiterimages/Thinkstock(LOS ANGELES) -- A new study indicates that regular use of nonsteroidal anti-inflammatory drugs (NSAIDs) could be associated with greater chance of erectile dysfunction.

Common over-the-counter NSAIDs include acetylsalicylic acid (aspirin), ibuprofen (Advil) and naproxen (Aleve).

In the cross-sectional study in a large health care system, the rate of erectile dysfunction was 35.2 percent among middle-aged men who regularly took NSAIDs compared to only 24 percent among those who did not, reported Dr. Steven Jacobsen, director of research at Kaiser Permanente Southern California in Los Angeles, and colleagues.

After adjusting for other factors which included age, ethnicity and body mass index, study authors say the difference in percentages worked out to a 1.22-fold greater probability of erectile dysfunction for NSAID users, according to the study published online in the journal Urology.

"While this raises the question of the role of inflammation and COX pathways in erectile dysfunction etiology, we cannot exclude alternative explanations," the researchers wrote.

Jacobsen told MedPage Today that if the association is indeed true, then it may be time to discuss the risks and benefits of using NSAIDs, whether for prevention or for treatment of various ailments.

Copyright 2011 ABC News Radio 

ABC News Radio