THE "NEW" PROSTATE CANCER INFOLINK

“Penile vibratory stimulation” or PVS is not a term that your Sitemaster had come across prior to seeing the abstract of a report on a pilot study just reported in BJU International. The study data don’t offer us any sort of fantastic breakthrough in the area of penile rehabilitation — but they are at least interesting.

Fode et al. report on the impact of PVS in preservation and restoration of erectile function and urinary continence among patients scheduled for treatment with nerve-sparing radical prostatectomy at one or other of two Danish university hospitals between January 2010 and March 2013. (Details about the trial are available on the ClinicalTrials.gov web site.) All patients enrolled in the study had to be fully continent prior to surgery and had to have a pre-treatment International Index of Erectile Function-5 (IIEF-5) score of at least 18. The patients were then randomized — before their surgery — to one of two groups:

• The PVS group, who were required to carry out “pelvic floor training” (Kegel exercises) and PVS at the frenulum of the penis once daily in their own homes for a minimum of 1 week prior to surgery, and then to re-initiate PVS in the same manner after surgery and after catheter removal for 6 weeks.
• The control group, who were required only to carry out Kegel exercises.

The device to be used by the patients undergoing PVS was a FERTICARE^® vibrator (manufactured by Multicept A/S, a Danish company, but available in the USA through a distributor). The patients were all evaluated at 3, 6, and 12 months post-surgery. Patients were considered to be continent post-surgery if they were using a maximum of 1 pad daily for security reasons.

Here are the key results of this small, pilot study:

• It is not entirely clear how many patients were initially enrolled into the study.
• Data from 68 patients were available for analysis.
  • 30/68 patients (44 percent) had been randomized to the PVS group
  • 38/68 patients (56 percent) had been randomized to the control group.
• At all time points post-surgery, IIEF-5 scores were higher among the patients in the PVS group compared to the control group.
• At 12 months post-surgery, the average (median) IIEF-5 score was
  • 18 for men in the PVS group
  • 7.5 for men in the control group
  • This difference reached borderline statistical significance (p = 0.09).
• Also at 12 months post-surgery,
  • 16/30 patients in the PVS group (53 percent) had an IIEF-5 score of ≥ 18.
  • 12/38 patients in the control group (32 percent) had an IIEF-5 score of ≥ 18.
  • This difference again reached borderline statistical significance (p = 0.07).
• With respect to any impact on continence
  • There were no significant differences in the proportions of continent patients between groups at 3, 6, or 12 months post-surgery.
  • 90 percent of patients in the PVS group were continent at 12 months post-surgery.
  • 95 percent of patients in the control group were continent at 12 months post-surgery.

Clearly this study was too small to be able to demonstrate any significant, documentable effect of PVS on recovery of erectile function post-surgery. On the other hand, the authors do report that this method

proved to be acceptable for most patients and there was a trend toward better erectile function with PVS.

We would note that the web site of the US distributor of this product includes statements suggesting that the products they sell are effective in assisting in the recovery of erectile function for prostate cancer patients. We are not aware of any data that actually can confirm such a claim at this time, nor do we know whether the U.S. Food & Drug Administration has approved any such products for this use.

Filed under: Living with Prostate Cancer, Management, Treatment | Tagged: erectile, function, penile, rehabilitation, stimulation, vibratory |