Transcutaneous Mechanical Nerve Stimulation (TMNS) by Vibration in the Treatment of Incontinence

Urinary Incontinence Clinical Trial

— TMNS  

Official title:

Transcutaneous Mechanical Nerve Stimulation (TMNS) by Vibration in the Treatment of Incontinence

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00695058
• Other study ID #: H-B-2007-047
• Status: Withdrawn
• Phase: Phase 3
• First received: June 9, 2008
• Last updated: February 23, 2012
• Start date: August 2008
• Est. completion date: September 2010

Study information

• Verified date: February 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

During transcutaneous mechanical nerve stimulation in spinal cord injured men an increase in pressure was observed in the external urethral sphincter along with an increase in bladder capacity. In a subsequent study it was demonstrated that TMNS in women could induce pressure increment of the external urethral sphincter. A pilot study have since shown that after 6 weeks of stimulation 24 out of 33 women suffering from urinary stress incontinence were able to contract their pelvic floor muscles and had become free of symptoms. Another pilot study has shown promising effect on the overactive bladder syndrome.

The present study aims to treat urinary incontinence and includes 3 groups of patients with 40 patients in each group: Women suffering from urinary stress incontinence, women suffering from urge incontinence and men suffering from urinary incontinence after a prostatectomy. A medical vibrator is used and in each group the subjects will be randomized to active treatment or placebo treatment.

In women the stimulation will be performed at the perineum every day for 6 weeks with an amplitude of 2 mm and a frequency of 100 Hz. In men the vibration parameter/location will be determined by the results of a pressure profile study also included. Results will be evaluated on the basis of questionnaires, micturition diaries and diaper tests.

If we are able to demonstrate a significant reduction in the incontinence symptoms in the subjects we asses that vibration can be a way of reestablishing a normal function of the pelvic floor muscles and bladder function in incontinent patients.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Women suffering from stress incontinence

• Women suffering from overactive bladder syndrome

• Men who are still incontinent at a minimum of one year after a radical prostatectomy

Exclusion Criteria:

• Pregnant and nursing women will not be included in the study

Study Design

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

Related Conditions & MeSH terms

• Urinary Incontinence

Intervention

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 perineum in women and the perineum or the frenulum in men. In the women the stimulation will be performed with a vibration amplitude of 2 mm and a frequency of 100 Hz. In the men the vibration parameter/location will be determined by the results of the new pressure profile studies (aim 3). A daily stimulation sequence consisting of 10 seconds of stimulation followed by a 10 second pause repeated 10 times will be used through 6 weeks in both the women with stress incontinence and overactive bladder syndrome. In the 3 groups of patients the subjects will be randomized to either active treatment or placebo treatment. The placebo treatment will be done with a vibration device with an amplitude of 0 mm. Subjects will be randomized by a draw.

Locations

Country	Name	City	State
Denmark	Department of Urology, Herlev University Hospital	Herlev
Denmark	The Regional Hospital of Viborg	Viborg
United States	Department of Urology, University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Copenhagen University Hospital at Herlev

Countries where clinical trial is conducted

United States,  Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diaper test - weight (grams); Micturition diary - The number of involuntary incontinence and normal micturition episodes; Amplitude of vibration (mm) and pressure (cm H2O) in the external sphincter of the urethra		Before treatment, after treatment and at follow up	No
Secondary	Validated symptom score (ICI-Q) including: changes in incontinence and micturition patterns; patients' subjective assessment of their symptoms		before treatment, after treatment and at follow up	No