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

Sponsor

Copenhagen University Hospital at Herlev (Other)

Overall Status

Completed

CT.gov ID

NCT01067261

Collaborator

Aarhus University Hospital Skejby (Other), Velux Fonden (Other)

Enrollment

Locations

Arms

36.9

Duration (Months)

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Erectile Dysfunction Urinary Incontinence	Device: Transcutaneous mechanical nerve stimulation (TMNS) Other: Pelvic floor muscle training	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

68 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

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

Study Start Date :

Feb 1, 2010

Actual Primary Completion Date :

Mar 1, 2013

Actual Study Completion Date :

Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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.	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 Names: FERTI CARE personel, Multicept A/S, Albertslund, Danmark
Active Comparator: Pelvic floor muscle training only This group will receive the normal pelvic floor muscle training after prostatectomy only.	Other: Pelvic floor muscle training Regular pelvic floor training which is offered to all patients undergoing a radical prostatectomy at Herlev Hospital.

Arm

Intervention/Treatment

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.

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 Names:

FERTI CARE personel, Multicept A/S, Albertslund, Danmark

Active Comparator: Pelvic floor muscle training only

This group will receive the normal pelvic floor muscle training after prostatectomy only.

Other: Pelvic floor muscle training

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

Outcome Measures

Primary Outcome Measures

Erectile function score by a validated symptom questionnaire (IIEF) [At 3 months, 6 months and 1 year]
Time to continence after surgery [At 3 months, 6 months and 1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Urology, Aarhus University Hospital, Skejby	Aarhus N		Denmark	DK-8200
2	Department of Urology, Herlev University Hospital	Herlev		Denmark	DK- 2730