Transcutaneous Mechanical Nerve Stimulation in the Treatment of Incontinence
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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 |
- 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 ]
- 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 ]
| Estimated Enrollment: | 60 |
| 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 |
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| Contact: Mikkel Fode, MD | + 45 38682093 | mikkelfode@gmail.com |
| Denmark | |
| Departement of Gynecology, Roskilde Hospital | Recruiting |
| Roskilde, Denmark, 4000 | |
| Contact: Martin Rudnicki, MD, PhD +45 47324007 pmru@regionsjaelland.dk | |
| Principal Investigator: Martin Rudnicki, MD / PhD | |
| 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: | December 4, 2012 |
| 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 Urination Disorders |
Urologic Diseases Urological Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013