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

NCT00695058 | Withdrawn Phase 3 DMC

• 1 other identifier: H-B-2007-047
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 3

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.

Conditions

Urinary Incontinence

Keywords

Stress incontinence; urge incontinence; overactive bladder syndrome; vibration; nerve stimulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (6)

1

EXPERIMENTAL

Women with stress incontinence treated with active TMNS (vibration)

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

2

PLACEBO COMPARATOR

Women with stress incontinence treated with placebo TMNS (vibration)with an amplitude of 0

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

3

EXPERIMENTAL

Women with overactive bladder syndrome treated with active TMNS (vibration)

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

4

PLACEBO COMPARATOR

Women with overactive bladder syndrome treated with placebo TMNS (vibration)with an amplitude of 0

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

5

EXPERIMENTAL

males who are still incontinent at a minimum of one year after a radical prostatectomy treated with active TMNS (vibration)

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

6

PLACEBO COMPARATOR

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

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

Interventions

Transcutaneous mechanical nerve stimulation by A medical vibrator (FERTI CARE personel, Multicept A/S, Albertslund, Danmark) DEVICE

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 in women and the perineum or the frenulum in men. In the women the stimulation will be performed with a vibration amplitude of 2 mm and a frequency of 100 Hz. In the men the vibration parameter/location will be determined by the results of the new pressure profile studies (aim 3). 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 in both the women with stress incontinence and overactive bladder syndrome. In the 3 groups of patients the subjects will be randomized to either active treatment or placebo treatment. The placebo treatment will be done with a vibration device with an amplitude of 0 mm. Subjects will be randomized by a draw.

1; 2; 3; 4; 5; 6

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Copenhagen University Hospital at Herlev: lead

Study Sites (3)

Department of Urology, University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Department of Urology, Herlev University Hospital

Herlev, DK 2730, Denmark

Location

The Regional Hospital of Viborg

Viborg, 8800, Denmark

Location

MeSH Terms

Conditions

Urinary Incontinence; Urinary Incontinence, Stress; Urinary Incontinence, Urge

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jens R Sonksen, MD, Ph.D

  Copenhagen University Hospital at Herlev

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 9, 2008
• First Posted: June 11, 2008
• Study Start: August 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: February 24, 2012

Record last verified: 2012-02

Locations

US (1); DK (2)