Prostate cancer: the first penile prosthesis 50 years ago. But few get it after a tumor from the NHS

Half a century ago a team of surgeons in Texas had the intuition to create the first prosthesis that replaces the hydraulic system of the penis. But 50 years later, today’s safe, effective, minimally invasive and easier to use interventions in the future are still not included in our country’s Lea, despite the recent approval of the tariff decree. So due to budget constraints, only a few public facilities ensure it and just 10% of Italians who need a penile prosthesis manage to have surgery in the hospital to return to normal sexual activity. The remaining 90% are forced to resort to the private sector. The intervention must be included as soon as possible in the essential levels of assistance because gender differences in cancer treatments are no longer acceptable, despite the problem affecting thousands of men and requiring a decisive change of pace. This is the request made by the experts of the Italian Society of Andrology (SIA), hitherto unheeded, at the center of the national congress underway in Rome until 25 June.

The complaint

Every year in Italy about 20,000 men undergo radical prostate removal surgery following a tumor and of these, at least 10,000 undergo erectile dysfunction with indications for penile prosthesis implantation to resolve it. But most candidates do not have access to treatment because it is excluded from the new tariff decree and the Regions are not required to provide it. Thus there are very few facilities available, in just as few public centres, distributed unevenly throughout the territory.

“Penile prostheses are not a habit or a luxury but a right to continue a normal and dignified life as a couple when medical therapies fail”, he declares Alexander Palmieri, president of SIA and professor of Urology at the Federico II University of Naples. “The therapeutic efficacy of these devices and the ‘non-aesthetic’ nature of the operation are in fact widely recognized by the most recent European guidelines for men recovering from oncological surgery for the prostate, but also for the bladder and rectum, which exceed the cancer and yet they still lose their sexual functionality when young. But the problem also concerns other diseases from diabetes to neurological pathologies up to deforming diseases of the penis that prevent erection. However – the expert recalls – contrary to what is now consolidated for women , for which the reimbursement of breast implants following a mastectomy has been foreseen for some time, men do not receive the same treatment after radical pelvic surgery”, underlines Palmieri.

“This happens because these are principals not included in the Lea that present a Drg that does not cover the expenses: 2740 euros compared to a cost for the prosthesis alone of about 8500 euros, plus the operating room and surgeons – remarked Marco Bitelli, co- president of the congress and Medical Director of the Urology Complex Hospital Unit at the San Sebastiano Hospital in Frascati – The consequence is that these aids are granted with a dropper, no more than 3/5 a year for each center where this surgery is practiced According to data from the SIA National Register, out of 3,000 requests, around 400 prostheses are supplied a year, 75% concentrated between the North and Centre. On balance, less than one out of 10 eligible patients accesses the ‘implantation through public and affiliated health care: all the others must go to private structures”.

“The Italian Society of Andrology renews its appeal to the Ministry and the Regions to modify the recently approved tariff decree and to include penile prosthesis surgery as soon as possible in the Lea, to guarantee all cancer and non-cancer patients, candidates for the system, fair and homogeneous access to treatments, intended to affect critical aspects related to the psychophysical health of thousands of men of all ages”, concludes Palmieri.

The first intervention

From the wooden prostheses created in the 16th century in France by Ambroise Paré, to the insertion of bones in the 30s, to the acrylic splints of the 50s, up to the insertion of polyethylene implants in the 60s, we will have to wait until July of 1973 when the first implanted hydraulic penile prosthesis was described in the journal Urology by Scott, Bradley and Timm. The surgery, performed successfully without rejection or infection problems by the authors at the Division of Urology of the Baylor College of Medicine Texas Medical Center in Houston, was performed with two pumps instead of one, placed in the scrotal area and submuscular insertion into the abdomen of a flat tank, which will later become cylindrical with a change of shape dictated above all to facilitate the work of the surgeon.

“From the first implant, the prostheses have evolved with the advent of new technologies, materials and with the improvement of the surgical technique they have become a safe, minimally invasive and effective procedure. The prosthetic placement takes about an hour and is completely hidden because there are no external components”, explains Palmieri. “Convalescence is very short and overall recovery times are rapid: within about a month and a half you can resume having an active sexual life with a 100% restored erection. The main risk is that of infection of the prosthesis, which requires immediate removal. However, this complication is very low and occurs in one case in every thousand implants”.

How prostheses work

The penile prosthesis is a mechanical device that restores the internal mechanism of erection without altering the external sensitivity of the penis in the emission of seminal fluid. There are currently two classes of prosthetics: inflatable and non-inflatable. The first, also called semi-rigid, is a device made up of two rigid silicone cylinders that are inserted into the natural cylinders of the penis, called corpora cavernosa. The device gives such a rigidity as to allow penetration at any time, so the penis is always “ready for use” but has a malleable core at the base, which allows the organ to be placed in the groin cavity.

The inflatable prosthesis, also called hydraulic, can mimic a state of flaccidity or erection depending on whether it is inflated or not. It consists of a very sophisticated closed circuit, made of two silicone cylinders which occupy the inside of the cavernous bodies which fill up with water from a tank, positioned near the bladder inside the abdomen. The liquid from the reservoir passes to the cylinders of the prosthesis through what is commonly referred to as a “pump”. It is an activator inserted inside the scrotum whose crushing makes the water pass from the tank to the two cylinders, which fill with fluid instead of blood and go into erection. Once the ratio is completed, the same activator is used to deflate the system, allowing the water to reverse from the cylinders to the tank. The prosthesis thus empties and the penis becomes flaccid again.

The future

Since the first prosthesis in 1973, research in the surgical field and in the production of devices has made great strides and today aims to create touchless prostheses, capable of functioning without a “pump”, easier to use and with lower risks of breakage of the hydraulic components.

“Today, a penile prototype is being tested at the Eleuterio Gonzalez university hospital of the Universidad Autonoma of Monterrey in Mexico, which has the advantage of being activated without the need to manually pump the scrotum, as typically occurs in conventional hydraulic systems”, declares Simone Cilio, andrologist of the Department of Neurosciences, Reproductive Sciences and Odontostomatology, Urology Unit of the “Federico II” University of Naples.” In this case, it is a modular neurotransmitter that perceives the excitatory stimulus from the central nervous system to trigger an erection. For the future – adds the andrologist – another mechanism is also being studied which allows the triggering of the erection function by thermal induction, thanks to the activation of an electromagnet.The prosthetic implant, also introduced in Italy a few years ago and today in trial at the Urological Institute and Department of Urology at Johns Hopkins University School of Medicine in Baltimore, was described in the study published in The Journal of Sexual Medicine. The prototype prosthesis consists of an implantable cylinder that uses nickel-titanium alloy tubing instead of rigid silicone. This type of non-inflatable prosthesis eliminates the need for reservoirs and pumps, making the device easier to use,” concludes Cilio.