Clinical trial NCT01366066: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Stress Urinary Incontinence
Urge Urinary Incontinence
Keywords: Stress incontinence
urge incontinence
overactive bladder syndrome
vibration
nerve stimulation
Lead sponsor: Copenhagen University Hospital at Herlev
Sponsor class: OTHER
Collaborators: name: Zealand University Hospital
First posted: 2011-06-03
Enrollment: 4
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Diaper test - weight (grams)
timeFrame: Assesment at baseline and again after 6 weeks of treatment (when treatment is terminated)
Secondary outcomes:
measure: Validated symptom score (ICI-Q) including: changes in incontinence and micturition patterns; patients' subjective assessment of their symptoms
timeFrame: Assesment at baseline and again after 6 weeks of treatment (when treatment is terminated)
measure: Treatment satisfaction
timeFrame: After 6 weeks of treatment (when treatment is terminated)
measure: Urethral pressure (in the stress group)
timeFrame: Assesment at baseline and again after 6 weeks of treatment (when treatment is terminated)
measure: Episodes of over active bladder during urodynamics (urge patients)
timeFrame: Assesment at baseline and again after 6 weeks of treatment (when treatment is terminated)
measure: Micturition diary - The number of involuntary incontinence and normal micturition episodes
timeFrame: Assesment at baseline and again after 6 weeks of treatment (when treatment is terminated)
Other outcomes:
Locations:
city: Roskilde
country: Denmark
facility: Departement of Gynecology, Roskilde Hospital
Study officials:
affiliation: Copenhagen University Hospital at Herlev
name: Mikkel Fode, MD
role: PRINCIPAL_INVESTIGATOR
References: