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Randomized Controlled Trial
. 2014 Jul;114(1):111-7.
doi: 10.1111/bju.12501. Epub 2014 Jan 22.

Penile vibratory stimulation in the recovery of urinary continence and erectile function after nerve-sparing radical prostatectomy: a randomized, controlled trial

Mikkel Fode  1 , Michael Borre, Dana A Ohl, Jonas Lichtbach, Jens Sønksen
Affiliations
Free PMC article
Randomized Controlled Trial

Penile vibratory stimulation in the recovery of urinary continence and erectile function after nerve-sparing radical prostatectomy: a randomized, controlled trial

Mikkel Fode et al. BJU Int. 2014 Jul.
Free PMC article

Abstract

Objective: To examine the effect of penile vibratory stimulation (PVS) in the preservation and restoration of erectile function and urinary continence in conjunction with nerve-sparing radical prostatectomy (RP).

Patients and methods: The present study was conducted between July 2010 and March 2013 as a randomized prospective trial at two university hospitals. Eligible participants were continent men with an International Index of Erectile Function-5 (IIEF-5) score of at least 18, scheduled to undergo nerve-sparing RP. Patients were randomized to a PVS group or a control group. Patients in the PVS group were instructed in using a PVS device (FERTI CARE(®) vibrator). Stimulation was performed at the frenulum once daily by the patients in their own homes for at least 1 week before surgery. After catheter removal, daily PVS was re-initiated for a period of 6 weeks. Participants were evaluated at 3, 6 and 12 months after surgery with the IIEF-5 questionnaire and questions regarding urinary bother. Patients using up to one pad daily for security reasons only were considered continent. The study was registered at http://clinicaltrials.gov/ (NCT01067261).

Results: Data from 68 patients were available for analyses (30 patients randomized to PVS and 38 patients randomized to the control group). The IIEF-5 score was highest in the PVS group at all time points after surgery with a median score of 18 vs 7.5 in the control group at 12 months (P = 0.09), but the difference only reached borderline significance. At 12 months, 16/30 (53%) patients in the PVS group had reached an IIEF-5 score of at least 18, while this was the case for 12/38 (32%) patients in the control group (P = 0.07). There were no significant differences in the proportions of continent patients between groups at 3, 6 or 12 months. At 12 months 90% of the PVS patients were continent, while 94.7% of the control patients were continent (P = 0.46).

Conclusion: The present study did not document a significant effect of PVS. However, the method proved to be acceptable for most patients and there was a trend towards better erectile function with PVS. More studies are needed to explore this possible effect further.

Keywords: erectile dysfunction; penile rehabilitation; penile vibratory stimulation; prostate cancer; radical prostatectomy; urinary incontinence.

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Figures

Fig 1
Fig 1
The FERTI CARE® vibrator. The vibratory stimulation of the device is delivered through a reusable but disposable black plastic disc as seen on the right side of the picture. The device was set to an amplitude of 2 mm and a vibration frequency of 100 Hz. Patients were instructed in stimulating the frenulum once daily with a sequence consisting of 10 s of stimulation followed by a 10-s pause repeated 10 times (for a total of 100 s of stimulation every day).
Fig 2
Fig 2
The flow of patients throughout the study.
See this image and copyright information in PMC

Comment in

References

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