Transcutaneous Mechanical Nerve Stimulation in the Treatment of Incontinence

NCT ID: NCT01366066

Last Updated: 2013-05-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2013-06-30

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.

Conditions

Stress Urinary Incontinence; Urge Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

TMNS treatment - Stress incontinence

Women with stress incontinence treated with active TMNS (vibration)

Group Type: ACTIVE_COMPARATOR

Transcutaneous mechanical nerve stimulation

Intervention Type: DEVICE

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.

No treatment - stress incontinence

Women with stress incontinence NOT treated with TMNS (vibration)

Group Type: NO_INTERVENTION

No interventions assigned to this group

TMNS treatment - Urge incontinence

Women with stress incontinence treated with TMNS (vibration)

Group Type: ACTIVE_COMPARATOR

Transcutaneous mechanical nerve stimulation

Intervention Type: DEVICE

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.

No treatment - urge incontinence

Women with urge incontinence NOT treated with TMNS (vibration)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

FERTI CARE personel, Multicept A/S, Albertslund, Danmark

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Zealand University Hospital

OTHER

Sponsor Role: collaborator

Copenhagen University Hospital at Herlev

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mikkel Fode, MD

Role: PRINCIPAL_INVESTIGATOR

Copenhagen University Hospital at Herlev

Locations

Departement of Gynecology, Roskilde Hospital

Roskilde, Denmark, Denmark

Countries

Denmark

Other Identifiers

H-2-2010-109

Identifier Type: -

Identifier Source: org_study_id