Transcutaneous Mechanical Nerve Stimulation in the Treatment of Incontinence

Stress Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01366066
• Other study ID #: H-2-2010-109
• Status: Terminated
• Phase: Phase 3
• First received: May 30, 2011
• Last updated: May 23, 2013
• Start date: May 2011
• Est. completion date: June 2013

Study information

• Verified date: May 2013
• Source: Copenhagen University Hospital at Herlev
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Dataprotection AgencyDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: June 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stress Urinary Incontinence
• Urge Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress
• Urinary Incontinence, Urge

Intervention

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.

Locations

Country	Name	City	State
Denmark	Departement of Gynecology, Roskilde Hospital	Roskilde

Sponsors (2)

Lead Sponsor	Collaborator
Copenhagen University Hospital at Herlev	University Hospital Roskilde

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diaper test - weight (grams)		Assesment at baseline and again after 6 weeks of treatment (when treatment is terminated)	No
Secondary	Validated symptom score (ICI-Q) including: changes in incontinence and micturition patterns; patients' subjective assessment of their symptoms		Assesment at baseline and again after 6 weeks of treatment (when treatment is terminated)	No
Secondary	Treatment satisfaction		After 6 weeks of treatment (when treatment is terminated)	No
Secondary	Urethral pressure (in the stress group)		Assesment at baseline and again after 6 weeks of treatment (when treatment is terminated)	No
Secondary	Episodes of over active bladder during urodynamics (urge patients)		Assesment at baseline and again after 6 weeks of treatment (when treatment is terminated)	No
Secondary	Micturition diary - The number of involuntary incontinence and normal micturition episodes		Assesment at baseline and again after 6 weeks of treatment (when treatment is terminated)	No