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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01067261
• Other study ID #: HC-2008-127
• Status: Completed
• Phase: Phase 3
• First received: February 10, 2010
• Last updated: May 23, 2013
• Start date: February 2010
• Est. completion date: March 2013

Study information

• Verified date: December 2012
• Source: Copenhagen University Hospital at Herlev
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Dataprotection AgencyDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 a-blockers

• Serious cardiovascular disease

• Severely reduced liver function,

• Retinitis pigmentosa,

• Non-arteritic ischemic optic neuropathy (NAION)

• Previous vascular infarction of the eye

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erectile Dysfunction
• Urinary Incontinence

Intervention

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:
• Pelvic floor muscle training
Regular pelvic floor training which is offered to all patients undergoing a radical prostatectomy at Herlev Hospital.

Locations

Country	Name	City	State
Denmark	Department of Urology, Aarhus University Hospital, Skejby	Aarhus N
Denmark	Department of Urology, Herlev University Hospital	Herlev

Sponsors (3)

Lead Sponsor	Collaborator
Copenhagen University Hospital at Herlev	Aarhus University Hospital Skejby, Velux Fonden

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Erectile function score by a validated symptom questionnaire (IIEF)		At 3 months, 6 months and 1 year	No
Primary	Time to continence after surgery		At 3 months, 6 months and 1 year	No