Home
 
       

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

This study is currenly Recruiting patients.
Sponsored by: Copenhagen University Hospital at Herlev

Purpose
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.
Study Type: Intervention
Condition Intervention Phase
Urinary Incontinence
Device: Transcutaneous mechanical nerve stimulation by A medical vibrator (FERTI CARE personel, Multicept A/S, Albertslund, Danmark) Phase 3
Study Design:Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Official Title: Transcutaneous Mechanical Nerve Stimulation (TMNS) by Vibration in the Treatment of Incontinence
Further Study Details:
Expected Total Enrollment:
Study Dates:August 2008 -

Eligibility
Ages Eligible for Study- Min: 18 Years Max: N/A
Gender: Both
Criteria

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

  • Location and Contact Information
    Please refer to this study by ClinicalTrials.gov identifier: NCT00695058
    Michigan
    Department of Urology, University of Michigan - Ann Arbor, Michigan 48109
    Dana A Ohl, MD daohl@med.umich.edu
    The Regional Hospital of Viborg - Viborg, 8800
    Eva K Andersen, MD evakleberg@gmail.com

    More Information
    Record Last Reviewed:February 2010
    Last Updated:February 10, 2010
    Record First Recieved:June 9, 2008
    ClinicalTrials.gov Identifier:NCT00695058
    Health Authority: United States Food and Drug Administration
    Information obtained from ClinicalTrials.gov on September 02, 2010

    footer Lib
      Last Modified:
    Questions or comments? Please contact our Webmaster.
    About Us, Terms of UsePrivacy Policy, Medical Board
    © NCERx LLC 2005. All rights reserved.