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

Copenhagen University Hospital at Herlev

Status and phase: Withdrawn; Phase 3

Conditions: Urinary Incontinence

Treatments: Device: Transcutaneous mechanical nerve stimulation by A medical vibrator (FERTI CARE personel, Multicept A/S, Albertslund, Danmark)

Study type: Interventional

Funder types: Other

Identifiers

NCT00695058

H-B-2007-047

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 6 patient groups, including a placebo group

1

Experimental group

Description:

Women with stress incontinence treated with active TMNS (vibration)

Treatment:

Device: Transcutaneous mechanical nerve stimulation by A medical vibrator (FERTI CARE personel, Multicept A/S, Albertslund, Danmark)

2

Placebo Comparator group

Description:

Women with stress incontinence treated with placebo TMNS (vibration)with an amplitude of 0

Treatment:

Device: Transcutaneous mechanical nerve stimulation by A medical vibrator (FERTI CARE personel, Multicept A/S, Albertslund, Danmark)

3

Experimental group

Description:

Women with overactive bladder syndrome treated with active TMNS (vibration)

Treatment:

Device: Transcutaneous mechanical nerve stimulation by A medical vibrator (FERTI CARE personel, Multicept A/S, Albertslund, Danmark)

4

Placebo Comparator group

Description:

Women with overactive bladder syndrome treated with placebo TMNS (vibration)with an amplitude of 0

Treatment:

Device: Transcutaneous mechanical nerve stimulation by A medical vibrator (FERTI CARE personel, Multicept A/S, Albertslund, Danmark)

5

Experimental group

Description:

males who are still incontinent at a minimum of one year after a radical prostatectomy treated with active TMNS (vibration)

Treatment:

Device: Transcutaneous mechanical nerve stimulation by A medical vibrator (FERTI CARE personel, Multicept A/S, Albertslund, Danmark)

6

Placebo Comparator group

Description:

males who are still incontinent at a minimum of one year after a radical prostatectomy treated with placebo TMNS (vibration)with an amplitude of 0

Treatment:

Device: Transcutaneous mechanical nerve stimulation by A medical vibrator (FERTI CARE personel, Multicept A/S, Albertslund, Danmark)