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

NCT ID: NCT01067261

Last Updated: 2013-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2013-03-31

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.

Conditions

Erectile Dysfunction; Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Transcutaneous mechanical nerve stimulation (TMNS)

Intervention Type: DEVICE

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.

Pelvic floor muscle training only

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

Group Type: ACTIVE_COMPARATOR

Pelvic floor muscle training

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: DEVICE

Pelvic floor muscle training

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

Intervention Type: OTHER

Other Intervention Names

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

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Aarhus University Hospital Skejby

OTHER

Sponsor Role: collaborator

Velux Fonden

OTHER

Sponsor Role: collaborator

Copenhagen University Hospital at Herlev

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jens R Sønksen, MD, Ph.D

Role: STUDY_DIRECTOR

Copenhagen University Hospital at Herlev

Locations

Department of Urology, Aarhus University Hospital, Skejby

Aarhus N, , Denmark

Department of Urology, Herlev University Hospital

Herlev, , Denmark

Countries

Denmark

References

Fode M, Borre M, Ohl DA, Lichtbach J, Sonksen J. Penile vibratory stimulation in the recovery of urinary continence and erectile function after nerve-sparing radical prostatectomy: a randomized, controlled trial. BJU Int. 2014 Jul;114(1):111-7. doi: 10.1111/bju.12501. Epub 2014 Jan 22.

Reference Type: DERIVED

PMID: 24127838 (View on PubMed)

Other Identifiers

HC-2008-127

Identifier Type: -

Identifier Source: org_study_id