Transcutaneous Mechanical Nerve Stimulation in the Treatment of Incontinence

This study has been terminated.
(Failure to recruit participants)
Sponsor:
Collaborator:
University Hospital Roskilde
Information provided by (Responsible Party):
Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier:
NCT01366066
First received: May 30, 2011
Last updated: May 23, 2013
Last verified: May 2013
  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 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 Intervention Phase
Stress Urinary Incontinence
Urge Urinary Incontinence
Device: Transcutaneous mechanical nerve stimulation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transcutaneous Mechanical Nerve Stimulation (TMNS) by Vibration in the Treatment of Stress Incontinence and Urge Incontinence

Resource links provided by NLM:


Further study details as provided by Copenhagen University Hospital at Herlev:

Primary Outcome Measures:
  • Diaper test - weight (grams) [ Time Frame: Assesment at baseline and again after 6 weeks of treatment (when treatment is terminated) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • Treatment satisfaction [ Time Frame: After 6 weeks of treatment (when treatment is terminated) ] [ Designated as safety issue: No ]
  • Urethral pressure (in the stress group) [ Time Frame: Assesment at baseline and again after 6 weeks of treatment (when treatment is terminated) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 4
Study Start Date: May 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: FERTI CARE personel, Multicept A/S, Albertslund, Danmark
No Intervention: No treatment - urge incontinence
Women with urge incontinence NOT treated with TMNS (vibration)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01366066

Locations
Denmark
Departement of Gynecology, Roskilde Hospital
Roskilde, Denmark, 4000
Sponsors and Collaborators
Copenhagen University Hospital at Herlev
University Hospital Roskilde
Investigators
Principal Investigator: Mikkel Fode, MD Copenhagen University Hospital at Herlev
  More Information

No publications provided

Responsible Party: Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier: NCT01366066     History of Changes
Other Study ID Numbers: H-2-2010-109
Study First Received: May 30, 2011
Last Updated: May 23, 2013
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Copenhagen University Hospital at Herlev:
Stress incontinence
urge incontinence
overactive bladder syndrome
vibration
nerve stimulation

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urinary Incontinence, Urge
Lower Urinary Tract Symptoms
Signs and Symptoms
Urination Disorders
Urologic Diseases
Urological Manifestations

ClinicalTrials.gov processed this record on October 21, 2014