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:
Aarhus University Hospital Skejby
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
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Copenhagen University Hospital at Herlev:

Primary Outcome Measures:
  • 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 ]

Enrollment: 68
Study Start Date: February 2010
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01067261

Locations
Denmark
Department of Urology, Aarhus University Hospital, Skejby
Aarhus N, Denmark, DK-8200
Department of Urology, Herlev University Hospital
Herlev, Denmark, DK- 2730
Sponsors and Collaborators
Copenhagen University Hospital at Herlev
Aarhus University Hospital Skejby
Velux Fonden
Investigators
Study Director: Jens R Sønksen, MD, Ph.D Copenhagen University Hospital at Herlev
  More Information

No publications provided

Responsible Party: Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier: NCT01067261     History of Changes
Other Study ID Numbers: HC-2008-127
Study First Received: February 10, 2010
Last Updated: May 23, 2013
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Copenhagen University Hospital at Herlev:
Nerve stimulation
TMNS
Prostatectomy
Prevention
Restoration
Treatment
Vibration
Non-invasive

Additional relevant MeSH terms:
Urinary Incontinence
Erectile Dysfunction
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 31, 2014