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

Phase 3

Withdrawn

• Conditions: Urinary Incontinence
• Interventions: Device: Transcutaneous mechanical nerve stimulation by A medical vibrator (FERTI CARE personel, Multicept A/S, Albertslund, Danmark)

• Registration Number: NCT00695058
• Lead Sponsor: Copenhagen University Hospital at Herlev

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-06-09
• Study First Submitted QC: 2008-06-10
• Study First Posted: 2008-06-11
• Study Start: 2008-08
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-23
• Last Update Posted: 2012-02-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Transcutaneous mechanical nerve stimulation by A medical vibrator (FERTI CARE personel, Multicept A/S, Albertslund, Danmark)	Women with stress incontinence treated with active TMNS (vibration)
2	Transcutaneous mechanical nerve stimulation by A medical vibrator (FERTI CARE personel, Multicept A/S, Albertslund, Danmark)	Women with stress incontinence treated with placebo TMNS (vibration)with an amplitude of 0
3	Transcutaneous mechanical nerve stimulation by A medical vibrator (FERTI CARE personel, Multicept A/S, Albertslund, Danmark)	Women with overactive bladder syndrome treated with active TMNS (vibration)
4	Transcutaneous mechanical nerve stimulation by A medical vibrator (FERTI CARE personel, Multicept A/S, Albertslund, Danmark)	Women with overactive bladder syndrome treated with placebo TMNS (vibration)with an amplitude of 0
5	Transcutaneous mechanical nerve stimulation by A medical vibrator (FERTI CARE personel, Multicept A/S, Albertslund, Danmark)	males who are still incontinent at a minimum of one year after a radical prostatectomy treated with active TMNS (vibration)
6	Transcutaneous mechanical nerve stimulation by A medical vibrator (FERTI CARE personel, Multicept A/S, Albertslund, Danmark)	males who are still incontinent at a minimum of one year after a radical prostatectomy treated with placebo TMNS (vibration)with an amplitude of 0

Primary Outcome Measures

Name	Time	Method
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	Before treatment, after treatment and at follow up

Secondary Outcome Measures

Name	Time	Method
Validated symptom score (ICI-Q) including: changes in incontinence and micturition patterns; patients' subjective assessment of their symptoms	before treatment, after treatment and at follow up

Trial Locations

Locations (3)

Department of Urology, Herlev University Hospital; 🇩🇰 Herlev, Denmark

The Regional Hospital of Viborg; 🇩🇰 Viborg, Denmark

Department of Urology, University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States