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

Last updated: May 23, 2013
Sponsor: Copenhagen University Hospital at Herlev
Overall Status: Completed

Phase

3

Condition

Enuresis

Urinary Incontinence

Erectile Dysfunction

Treatment

N/A

Clinical Study ID

NCT01067261
HC-2008-127
  • Ages > 18
  • Male

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Scheduled to undergo nerve sparing radical prostatectomy

  • Continent before surgery

  • A minimum score on the IIEF-questionnaire of 18

  • Sexually active

Exclusion

Exclusion Criteria:

  • Treatment with nitrates

  • Treatment with α-blockers

  • Serious cardiovascular disease

  • Severely reduced liver function,

  • Retinitis pigmentosa,

  • Non-arteritic ischemic optic neuropathy (NAION)

  • Previous vascular infarction of the eye

Study Design

Total Participants: 68
Study Start date:
February 01, 2010
Estimated Completion Date:
March 31, 2013

Connect with a study center

  • Department of Urology, Aarhus University Hospital, Skejby

    Aarhus N, DK-8200
    Denmark

    Site Not Available

  • Department of Urology, Herlev University Hospital

    Herlev, DK- 2730
    Denmark

    Site Not Available

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