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Transcutaneous Mechanical Nerve Stimulation in the Treatment of Incontinence

Primary Purpose

Stress Urinary Incontinence, Urge Urinary Incontinence

Status
Terminated
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
Transcutaneous mechanical nerve stimulation
Sponsored by
Copenhagen University Hospital at Herlev
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring Stress incontinence, urge incontinence, overactive bladder syndrome, vibration, nerve stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Departement of Gynecology, Roskilde Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

No Intervention

Active Comparator

No Intervention

Arm Label

TMNS treatment - Stress incontinence

No treatment - stress incontinence

TMNS treatment - Urge incontinence

No treatment - urge incontinence

Arm Description

Women with stress incontinence treated with active TMNS (vibration)

Women with stress incontinence NOT treated with TMNS (vibration)

Women with stress incontinence treated with TMNS (vibration)

Women with urge incontinence NOT treated with TMNS (vibration)

Outcomes

Primary Outcome Measures

Diaper test - weight (grams)

Secondary Outcome Measures

Validated symptom score (ICI-Q) including: changes in incontinence and micturition patterns; patients' subjective assessment of their symptoms
Treatment satisfaction
Urethral pressure (in the stress group)
Episodes of over active bladder during urodynamics (urge patients)
Micturition diary - The number of involuntary incontinence and normal micturition episodes

Full Information

First Posted
May 30, 2011
Last Updated
May 23, 2013
Sponsor
Copenhagen University Hospital at Herlev
Collaborators
Zealand University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01366066
Brief Title
Transcutaneous Mechanical Nerve Stimulation in the Treatment of Incontinence
Official Title
Transcutaneous Mechanical Nerve Stimulation (TMNS) by Vibration in the Treatment of Stress Incontinence and Urge Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Terminated
Why Stopped
Failure to recruit participants
Study Start Date
May 2011 (undefined)
Primary Completion Date
May 2013 (Anticipated)
Study Completion Date
June 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Copenhagen University Hospital at Herlev
Collaborators
Zealand University Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence, Urge Urinary Incontinence
Keywords
Stress incontinence, urge incontinence, overactive bladder syndrome, vibration, nerve stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TMNS treatment - Stress incontinence
Arm Type
Active Comparator
Arm Description
Women with stress incontinence treated with active TMNS (vibration)
Arm Title
No treatment - stress incontinence
Arm Type
No Intervention
Arm Description
Women with stress incontinence NOT treated with TMNS (vibration)
Arm Title
TMNS treatment - Urge incontinence
Arm Type
Active Comparator
Arm Description
Women with stress incontinence treated with TMNS (vibration)
Arm Title
No treatment - urge incontinence
Arm Type
No Intervention
Arm Description
Women with urge incontinence NOT treated with TMNS (vibration)
Intervention Type
Device
Intervention Name(s)
Transcutaneous mechanical nerve stimulation
Other Intervention Name(s)
FERTI CARE personel, Multicept A/S, Albertslund, Danmark
Intervention Description
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.
Primary Outcome Measure Information:
Title
Diaper test - weight (grams)
Time Frame
Assesment at baseline and again after 6 weeks of treatment (when treatment is terminated)
Secondary Outcome Measure Information:
Title
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)
Title
Treatment satisfaction
Time Frame
After 6 weeks of treatment (when treatment is terminated)
Title
Urethral pressure (in the stress group)
Time Frame
Assesment at baseline and again after 6 weeks of treatment (when treatment is terminated)
Title
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)
Title
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)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mikkel Fode, MD
Organizational Affiliation
Copenhagen University Hospital at Herlev
Official's Role
Principal Investigator
Facility Information:
Facility Name
Departement of Gynecology, Roskilde Hospital
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark

12. IPD Sharing Statement

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Transcutaneous Mechanical Nerve Stimulation in the Treatment of Incontinence

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