Urinary Incontinence Clinical Trial
Official title:
Transcutaneous Mechanical Nerve Stimulation (TMNS) by Vibration in the Preservation and Restoration of Urinary Continence and Erectile Function and in the Treatment of Erectile Dysfunction and Urinary Incontinence in Conjunction With Nerve Sparing Radical Prostatectomy
After radical prostatectomy nerve damage in the pelvic floor usually occurs. This causes
side effects in the form of incontinence and erectile dysfunction.
It has previously been shown that one can stimulate the nerves of the pelvic floor by means
of transcutaneous mechanical nerve stimulation (TMNS) done through vibration. This study
will examine the effect of TMNS in the preservation and restoration of urinary continence
and erectile function and in the treatment of urinary incontinence and erectile dysfunction
in conjunction with radical prostatectomy.
The theory is that by means of TMNS one can stimulate the nerves of the pelvic floor and the
penis which may improve their function and there by prevent or minimize the occurrence of
incontinence and erectile dysfunction following pelvic surgery. Vibration may also help to
eliminate these symptoms once they have occurred. It is possible that TMNS will also
directly increase the blood flow in the cavernosal tissue thus aiding in the preservation of
this tissue. In case the improved nerve function is not great enough to secure satisfactory
erectile function in itself it may still improve the effect of PDE-5-inhibitors.
In pilot studies TMNS has already shown an effect in the treatment of urinary continence.
In this study the patients will be randomized to either TMNS treatment or no TMNS treatment.
In both groups the patients will participate in a pelvic floor muscle training program. In
the group receiving active treatment this will be supplemented by TMNS treatment. The two
groups will be evaluated and compared with regard to erectile function time to continence
after surgery.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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