Transcutaneous Mechanical Nerve Stimulation in the Treatment of Incontinence

Sponsor

Copenhagen University Hospital at Herlev (Other)

Overall Status

Terminated

CT.gov ID

NCT01366066

Collaborator

Zealand University Hospital (Other)

Enrollment

Location

Arms

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Stress Urinary Incontinence Urge Urinary Incontinence	Device: Transcutaneous mechanical nerve stimulation	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

4 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2011

Anticipated Primary Completion Date :

May 1, 2013

Anticipated Study Completion Date :

Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: TMNS treatment - Stress incontinence Women with stress incontinence treated with active TMNS (vibration)	Device: Transcutaneous mechanical nerve stimulation 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. Other Names: FERTI CARE personel, Multicept A/S, Albertslund, Danmark
No Intervention: No treatment - stress incontinence Women with stress incontinence NOT treated with TMNS (vibration)
Active Comparator: TMNS treatment - Urge incontinence Women with stress incontinence treated with TMNS (vibration)	Device: Transcutaneous mechanical nerve stimulation 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. Other Names: FERTI CARE personel, Multicept A/S, Albertslund, Danmark
No Intervention: No treatment - urge incontinence Women with urge incontinence NOT treated with TMNS (vibration)

Outcome Measures

Primary Outcome Measures

Diaper test - weight (grams) [Assesment at baseline and again after 6 weeks of treatment (when treatment is terminated)]

Secondary Outcome Measures

Validated symptom score (ICI-Q) including: changes in incontinence and micturition patterns; patients' subjective assessment of their symptoms [Assesment at baseline and again after 6 weeks of treatment (when treatment is terminated)]
Treatment satisfaction [After 6 weeks of treatment (when treatment is terminated)]
Urethral pressure (in the stress group) [Assesment at baseline and again after 6 weeks of treatment (when treatment is terminated)]
Episodes of over active bladder during urodynamics (urge patients) [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 [Assesment at baseline and again after 6 weeks of treatment (when treatment is terminated)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Women suffering from stress incontinence OR Women suffering from urge incontinence /overactive bladder syndrome
Ongoing anticholinergic treatment in the urge incontinence/overactive bladder syndrome group
Patient capable of understanding protocol and performing treatment

Exclusion Criteria:

On going pregnancy or breast feeding
Treatment with anticholinergic medications in the stress incontinence group
Treatment with diuretic drugs
Acute illness (including infection, trauma and haematuria)
Fibromyalgia
Faecal incontinence
Known neurological disease
Bladder pain syndrome
Genital prolaps > stage 2 on the Pelvic Organ Prolapse Quantification System POP-Q
Previous treatment with neuromodulation or Botox
Previous pelvic floor surgery or radiation