'Shock' therapy for ED

PHOTO: 'Shock' therapy for ED

Extracorporeal Shockwave Lithotripsy (ESWL) for the treatment of urinary stones was pioneered by urologists in Germany in the mid-1980s. It was arguably recognized as the greatest invention in medicine at that time!

ESWL was brought to Malaysia in early 1988, and within a short period, all urinary stone treatments were done without open surgery, albeit with the support of endourological procedures in a certain number of cases.

In recent years, ESWL has been used in the treatment of shoulder stiffness/pain and Peyronie's disease with limited success.

Today, ESWL is being used successfully in many centres to treat men suffering from erectile dysfunction (ED).

Painless shockwaves delivered to the penis in stages over six weeks have been found to increase the blood flow to the penis significantly.

Over the past one year, well-conducted studies have confirmed that ESWL treatment is highly effective in treating men suffering from ED.

The results in these centres have shown that in the short term (up to a year), its efficacy is similar, if not better than, the current oral phosphodiesterase type 5 inhibitors (PDE5i) used to treat ED.

In a few series, patients who initially failed to respond to PDE5i, responded to ESWL, and a number of them subsequently become responsive to PDE5i.

A novel treatment

ED shockwave therapy (EDSWT) is currently recognised as a novel innovative approach to treat vasculogenic ED (ie ED caused by disorder of the blood vessels). Apparently, all vasculogenic ED patients will benefit from EDSWT in varying degrees.

In the recent Annual Congress of the International Society of Men's Health held early this month, Prof Y. Vardi reported a series of studies dating back to 2009.

The first pilot study involved 20 middle-aged patients with moderate to severe ED (mean International Index of Erectile Function-ED score of 13.5 out of 25). He excluded men with ED from neurogenic (caused by nerve problems), psychogenic (caused by mental problems) or post-pelvic surgical causes.

Low intensity shockwaves were applied to the penile shaft and crus (base of penis) for three minutes in five different penile sites (300 shocks per site) without any painkillers.

The treatment included two sessions per week for three weeks, and was repeated after a three week no-treatment interval.

At the end of the nine week treatment regime, 15 patients (75 per cent) responded to the therapy. Prior to the intervention, all the patients were on PDE5i therapy - five with poor response and 15 with good response.

Overall, 12 patients did not require PDE5i therapy three months after completing the shockwave treatment.

At one year, nine subjects showed improvement from an average of 14.4 to 23.3 in the IIEF-Erectile Function score (max score 15 of 25). None of the patients reported pain or any other side effects from the study.

This first pilot study was followed by a randomised sham controlled double blind study involving 60 vasculogenic ED patients who, at screening, were responders to PDE5i therapy (IIEF-EF score of >21).

The results showed clearly that 65 per cent (26/40) of the treated group, compared to 20 per cent of the sham group (p=0.0007), increased their IIEF-EF score by ≥5 points.

The treated patients also reported significantly higher satisfaction rate and increased flow-mediated dilatation parameters compared to the sham group.

Prof Vardi went on to present a study involving 24 patients with severe ED, who were not responding to oral medication.

At the end of the 12 week study, 80 per cent of the patients achieved a rigidity score of ≥3 out of 5 (p<0.0001). Five of the 15 subjects were normalized (IIEF-EF score >21) with the use of PDE5i.

Prof Vardi concluded that EDSWT is a new modality that can be used to effectively treat a subgroup of ED patients who fail PDE5i therapy, and this study confirmed the potential clinical benefits of this novel shockwave therapy in restoring erectile function.

Currently, patients with severe vasculogenic ED who fail oral therapies often resort to vacuum pumps, injection therapies or penile implants if they want to resume sexual activities.

The experience with shockwaves (EDSWT) has shown that up to 70 per cent of these difficult-to-treat cases can be salvaged, and become responsive to PDE5i.

Prof Vardi's study results have been duplicated by many centres in Europe, Japan, Korea and India.

Going beyond ED

EDSWT utilizes low-intensity extracorporeal shockwaves focusing on penile blood vessels, resulting in development of numerous tiny vessels (neovascularization) in the shaft and crus (base) of the penis.

This technology has been used successfully in cardiology to bring about revascularization of ischaemic tissues.

Low intensity shockwaves are also currently being experimented on in the treatment of chronic pelvic pain syndrome, and in aesthetics medicine to treat cellulite.

The discovery of sildenafil (Viagra), a PDE5i, revolutionised the management of ED in the 1990s. Four of six PDE5i are available in Malaysia, and they have been used very successfully in an on-demand basis in treating men with ED.

Lately, modification of the treatment regime using daily low dose PDE5i is preferred by men who cannot tolerate the side effects (headache, backache or flushing) of on-demand dosages. A proportion of men who desire spontaneity in their sex life also favour using daily dose PDE5i.

Recently, the US Food & Drug Administra-tion (FDA) approved the use of daily PDE5i in treating men with lower urinary tract symptoms secondary to prostate enlargement. This is certainly another milestone in the expanding usage of PDE5i.

Daily high doses of sildenafil taken two to three times per day has already been proven and approved to treat patients (including children) who suffer from debilitating life-threatening pulmonary arterial hypertension.

We have certainly come full circle with therapies for ED that continue to evolve and marvel medical science with their ever-expanding applications.

ESWL, which dramatically changed the treatment of urinary stones, is certainly on the verge of changing the treatment of men suffering from erectile dysfunction.

It is unimaginable that ESWL, a powerful but safe energy that has been used by urologists to crush nearly all stones in the urinary system, can be harnessed to deliver painless, controlled shock energy to bring new blood supply to the penis.

Urologists are certainly living in exciting times. We have literally grown up with the lithotripter. The powerful energy which we unleash to crush stones safely can also be controlled and tamed to caress the penis back to 'life'.

Urologists are also helping researchers in other fields of medicine to innovate the use of shockwave energy in the treatment of other medical conditions.