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

Withdrawn before enrolling · Phase 3 · Has a placebo group

Conditions studied: Urinary Incontinence

In brief

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.

Key facts

Study ID

NCT00695058

Run by

Copenhagen University Hospital at Herlev

People needed

0

Starts

2008-08-01

Expected to finish

2010-09-01

Last updated by the study team

2012-02-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• Department of Urology, University of Michigan — Ann Arbor, Michigan, United States
• Department of Urology, Herlev University Hospital — Herlev, Denmark
• The Regional Hospital of Viborg — Viborg, Denmark

Full record on ClinicalTrials.gov

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