Urinary Incontinence
Conditions
Keywords
Stress incontinence, urge incontinence, overactive bladder syndrome, vibration, nerve stimulation
Brief 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.
Interventions
DEVICETranscutaneous 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.
Sponsors
Copenhagen University Hospital at Herlev
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Denmark, United States
Outcome results
None listed