Clinical trial NCT00695058: Transcutaneous Mechanical Nerve Stimulation (TMNS) by Vibration in the Treatment of Incontinence
Official title: Transcutaneous Mechanical Nerve Stimulation (TMNS) by Vibration in the Treatment of Incontinence
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Urinary Incontinence
Keywords: Stress incontinence
urge incontinence
overactive bladder syndrome
vibration
nerve stimulation
Lead sponsor: Copenhagen University Hospital at Herlev
Sponsor class: OTHER
First posted: 2008-06-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
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 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 3 groups of patients with 40 patients in each group: Women suffering from urinary stress incontinence, women suffering from urge incontinence and men suffering from urinary incontinence after a prostatectomy. A medical vibrator is used and in each group the subjects will be randomized to active treatment or placebo treatment.

In women 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. In men the vibration parameter/location will be determined by the results of a pressure profile study also included. Results will be evaluated on the basis of questionnaires, micturition diaries and diaper tests.

If we are able to demonstrate a significant reduction in the incontinence symptoms in the subjects we 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
* Women suffering from overactive bladder syndrome
* Men who are still incontinent at a minimum of one year after a radical prostatectomy

Exclusion Criteria:

* Pregnant and nursing women will not be included in the study

Primary outcomes:
measure: Diaper test - weight (grams); Micturition diary - The number of involuntary incontinence and normal micturition episodes; Amplitude of vibration (mm) and pressure (cm H2O) in the external sphincter of the urethra
timeFrame: Before treatment, after treatment and at follow up
Secondary outcomes:
measure: Validated symptom score (ICI-Q) including: changes in incontinence and micturition patterns; patients' subjective assessment of their symptoms
timeFrame: before treatment, after treatment and at follow up
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Department of Urology, University of Michigan
state: Michigan
city: Herlev
country: Denmark
facility: Department of Urology, Herlev University Hospital
city: Viborg
country: Denmark
facility: The Regional Hospital of Viborg
Study officials:
affiliation: Copenhagen University Hospital at Herlev
name: Jens R Sonksen, MD, Ph.D
role: STUDY_DIRECTOR
References: