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

This study has been completed.
Sponsor:
Collaborators:
Skejby Hospital
Velux Fonden
Information provided by (Responsible Party):
Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier:
NCT01067261
First received: February 10, 2010
Last updated: May 23, 2013
Last verified: December 2012

February 10, 2010
May 23, 2013
February 2010
March 2013   (final data collection date for primary outcome measure)
  • Erectile function score by a validated symptom questionnaire (IIEF) [ Time Frame: At 3 months, 6 months and 1 year ] [ Designated as safety issue: No ]
  • Time to continence after surgery [ Time Frame: At 3 months, 6 months and 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01067261 on ClinicalTrials.gov Archive Site
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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
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Erectile Dysfunction
  • Urinary Incontinence
  • Device: Transcutaneous mechanical nerve stimulation (TMNS)

    Device: Transcutaneous mechanical nerve stimulation by A medical vibrator (FERTI CARE personel, Multicept A/S, Albertslund, Danmark)

    A medical vibrator (FERTI CARE personel, Multicept A/S, Albertslund, Denmark) will be used. The stimulation works through a vibrating disc of hard plastic with a diameter of 3.5 cm. The stimulation point will be the frenulum. A stimulation sequence consisting of 10 seconds of stimulation followed by a 10 second pause repeated 10 times will be used. The treatment will be initiated 1 to 4 weeks before the radical prostatectomy and re-initiated 0 to 14 days after the operation. The treatment will then continue for 6 weeks. The stimulation will be preformed daily by the patients in their own homes.

    Other Name: FERTI CARE personel, Multicept A/S, Albertslund, Danmark
  • Other: Pelvic floor muscle training
    Regular pelvic floor training which is offered to all patients undergoing a radical prostatectomy at Herlev Hospital.
  • Experimental: TMNS and pelvic floor muscle training
    This group will receive both the normal pelvic floor muscle training and the TMNS vibration therapy following their radical prostatectomy. Treatment with TMNS will start before the surgery and continue 6 weeks after the surgery.
    Intervention: Device: Transcutaneous mechanical nerve stimulation (TMNS)
  • Active Comparator: Pelvic floor muscle training only
    This group will receive the normal pelvic floor muscle training after prostatectomy only.
    Intervention: Other: Pelvic floor muscle training
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
68
March 2013
March 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Scheduled to undergo nerve sparing radical prostatectomy
  • Continent before surgery
  • A minimum score on the IIEF-questionnaire of 18
  • Sexually active

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01067261
HC-2008-127
No
Copenhagen University Hospital at Herlev
Copenhagen University Hospital at Herlev
  • Skejby Hospital
  • Velux Fonden
Study Director: Jens R Sønksen, MD, Ph.D Copenhagen University Hospital at Herlev
Copenhagen University Hospital at Herlev
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP