Urinary Incontinence Clinical Trial
Official title:
Transcutaneous Mechanical Nerve Stimulation (TMNS) by Vibration in the Treatment of Incontinence
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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