A Phase 3 interventional study of Transcutaneous mechanical nerve stimulation in Stress Urinary Incontinence and Urge Urinary Incontinence, sponsored by Copenhagen University Hospital at Herlev. Terminated at 1 site in Denmark. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-05-24.
Sponsored by Copenhagen University Hospital at Herlev · Phase 3, Interventional, and Treatment
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 Transcutaneous Mechanical Nerve Stimulation (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 2 groups of patients with 30 patients in each group: Women suffering from urinary stress incontinence and women suffering from urge incontinence. A medical vibrator is used and in each group the subjects will be randomized to vibration treatment or no vibration treatment. All patients will receive pelvic floor training and all women suffering from urge incontinence will receive anticholinergic medications.
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. Results will be evaluated on the basis of questionnaires, micturition diaries and diaper tests.
If the investigators are able to demonstrate a significant reduction in the incontinence symptoms in the subjects the investigators asses that vibration can be a way of reestablishing a normal function of the pelvic floor muscles and bladder function in incontinent patients.
1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.
This study's enrollment of 4 is below the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →Copenhagen University Hospital at Herlev is the lead sponsor of 76 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Women with stress incontinence treated with active TMNS (vibration)
Device: Transcutaneous mechanical nerve stimulation
Women with stress incontinence NOT treated with TMNS (vibration)
Women with stress incontinence treated with TMNS (vibration)
Device: Transcutaneous mechanical nerve stimulation
Women with urge incontinence NOT treated with TMNS (vibration)
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. The stimulation will be performed with a vibration amplitude of 2 mm and a frequency of 100 Hz. 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.
Also known as: FERTI CARE personel, Multicept A/S, Albertslund, Danmark
Diaper test - weight (grams)
Time frame: Assesment at baseline and again after 6 weeks of treatment (when treatment is terminated)
Validated symptom score (ICI-Q) including: changes in incontinence and micturition patterns; patients' subjective assessment of their symptoms
Time frame: Assesment at baseline and again after 6 weeks of treatment (when treatment is terminated)
Treatment satisfaction
Time frame: After 6 weeks of treatment (when treatment is terminated)
Urethral pressure (in the stress group)
Time frame: Assesment at baseline and again after 6 weeks of treatment (when treatment is terminated)
Episodes of over active bladder during urodynamics (urge patients)
Time frame: Assesment at baseline and again after 6 weeks of treatment (when treatment is terminated)
Micturition diary - The number of involuntary incontinence and normal micturition episodes
Time frame: Assesment at baseline and again after 6 weeks of treatment (when treatment is terminated)
This study is terminated, as verified in May 2013. You cannot join it, but the record below documents what was studied.
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Copenhagen University Hospital at Herlev