Transcutaneous Mechanical Nerve Stimulation in the Treatment of Incontinence

May 23, 2013 updated by: Copenhagen University Hospital at Herlev

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Roskilde, Denmark, 4000
        • Departement of Gynecology, Roskilde Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Diaper test - weight (grams)
Time Frame: Assesment at baseline and again after 6 weeks of treatment (when treatment is terminated)
Assesment at baseline and again after 6 weeks of treatment (when treatment is terminated)

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
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)
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)
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)
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)
Assesment at baseline and again after 6 weeks of treatment (when treatment is terminated)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Copenhagen University Hospital at Herlev

Collaborators

Zealand University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Anticipated)

May 1, 2013

Study Completion (Anticipated)

June 1, 2013

Study Registration Dates

First Submitted

May 30, 2011

First Submitted That Met QC Criteria

June 2, 2011

First Posted (Estimate)

June 3, 2011

Study Record Updates

Last Update Posted (Estimate)

May 24, 2013

Last Update Submitted That Met QC Criteria

May 23, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-2-2010-109

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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