THE "NEW" PROSTATE CANCER INFOLINK

On our social network yesterday, a new member asked about a form of treatment called “GAINSWave” for men with erectile dysfunction (ED) after treatment for localized prostate cancer. We had never heard of GAINSWave prior to this question.

GAINSWave is the brand name for a form of low-intensity, extracorporeal shockwave therapy or LI-ESWT and appears to be being aggressively marketed as a treatment for ED. If you go onto Google and search for GAINSWave, you will find lots of links to very positive information about this form of therapy. Here, for example, is the link to the official product web site. Note what it does not tell you, which is the name of the maker of this product! It turns out that that is a company in Florida called HEALTHGains, which appears to be owned by an anesthesiologist called Dr. Richard Gaines who claims expertise in “anti-aging” therapies for men and women.

So we had four basic questions about LI-ESWT:

1. Has it been approved for the treatment of  erectile dysfunction by the US Food and Drug Administration (FDA)?
2. What data exist on the use of LI-ESWT as a treatment for erectile dysfunction in general?
3. What data exist on the use of LI-ESWT in the treatment of erectile dysfunction subsequent to treatment for localized prostate cancer?
4. Is this form of treatment for ED covered by Medicare or any medical insurance plans?

According to the information on the GAINSWave web site, this procedure

uses pulsating acoustic shockwaves to stimulate the growth of new blood vessels in the penis. This increases the blood flow to the penis and improves sexual function. In addition, the GAINSWave Procedure stimulates the growth of new nerve tissue in the penis. This process, called neurogenesis, enhances sensitivity in the penis. Because this procedure is non-invasive it is referred to as the “extracorporeal shockwave therapy” or ESWT.

Medical equipment that can be used to generate low-intensity extrascorporeal shockwaves is used in the treatment of a number of medical conditions. However, after searching the FDA’s web site, we have been unable to find any suggestion that the GAINSWave procedure (or any other form of LI-ESWT technology) has been approved by the FDA as a form of treatment for erectile dysfunction. So much for Question 1 above.

We then went to PubMed to search for relevant scientific literature.

When we searched for low-intensity shockwave therapy + erectile dysfunction and associated terminology, we found 15 papers in total, several of which were review articles, but including data from three relatively small, randomized clinical trials.

Most of these papers dealt with the effect of LI-ESWT in men with “normal”, i.e., age-related, vasculogenic ED. The data presented in these papers (including the three randomized clinical trials) appear to be conflicting. The best we could see was that the technique worked in those men who had already had a positive response to standard treatment with PDE-5 inhibitors like sildenafil (Viagra) and tadalafil (Cialis). In two of the randomized trials there seemed to be no significant or clinically meaningful effect at all.

We found just one paper (by Frey et al,, in Denmark) that dealt specifically with the use of LI-ESWT as a form of treatment for ED in men who had such dysfunction after treatment for localized prostate cancer (by radical prostatectomy with bilateral nerve sparing). In that paper (published in 2016) the authors describe the outcomes of treatment of 15/18 men with an average (median) age of 62 years who received LI-ESWT at between 12 months and 54 months after their surgery. The authors report that:

• The patients’ IIEF-5 scores prior to their radical prostatectomies were between 22 and 25 (out of a maximum score of 25).
• The patients’ baseline IIEF-5 scores after their radical prostatectomies and before LI-ESWT ranged from 5 to 20 (median, 9.5).
• The change in the patients’ IIEF-5 scores from baseline at 1 month after LI-ESWT ranged from −1 to +8 (median, +3.5).
• The change in the patients’ IIEF-5 scores from baseline at 1 year after LI-ESWT ranged from −3 to +14 (median, +1.0).
• There were no serious side effects associated with this treatment.

So according to this study, for most of the 15 patients for whom outcomes were available at 1 month and 1 year after LI-EWST, there appears to have been, at best, a small improvement in their ED after 1 month, which decreased again over time in the vast majority of patients, and this study deals only with men who had a bilateral, nerve-sparing form of radical prostatectomy.

Frey et al. concluded (with some caution) that:

LI-ESWT may improve erectile function after bilateral nerve-sparing RP.

We were unable to find any data dealing with the efficacy of LI-ESWT as a treatment for ED in men with prostate cancer who had received any other form of first-line treatment for prostate cancer (e.g., external beam radiation therapy, brachytherapy, cryotherapy, etc.).

It appears to us that LI-ESWT may, indeed, have some benefit as a treatment for ED in some men, and more particularly in some men who have been treated for prostate cancer by a bilateral nerve-sparing form of radical prostatectomy. However, that benefit is likely to be limited and it is likely to be temporary.

Patients who want to consider this form  of treatment for ED — and more specifically for ED after treatment for localized prostate cancer — would be wise to have very low expectations about whether this treatment is actually going to work well for them as individuals. The promotional claims being made about this form of treatment for ED do not seem, at this time, to be supported by very much reliable data.

We were unable to find any data suggesting that Medicare or any health insurance company would cover the costs of this form of treatment for ED at this time. So much for Question 4.

Filed under: Living with Prostate Cancer | Tagged: dysfunction, ED, erectile, GAINSWave, LI-ESWT, low-intensity, shockwave |