Clinical trial NCT01067261: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Erectile Dysfunction
Urinary Incontinence
Keywords: Nerve stimulation
TMNS
Prostatectomy
Prevention
Restoration
Treatment
Vibration
Non-invasive
Lead sponsor: Copenhagen University Hospital at Herlev
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital Skejby
name: Velux Fonden
First posted: 2010-02-11
Enrollment: 68
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Erectile function score by a validated symptom questionnaire (IIEF)
timeFrame: At 3 months, 6 months and 1 year
measure: Time to continence after surgery
timeFrame: At 3 months, 6 months and 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Department of Urology, Aarhus University Hospital, Skejby
city: Herlev
country: Denmark
facility: Department of Urology, Herlev University Hospital
Study officials:
affiliation: Copenhagen University Hospital at Herlev
name: Jens R Sønksen, MD, Ph.D
role: STUDY_DIRECTOR
References:
citation: 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.