Transcutaneous Mechanical Nerve Stimulation in the Treatment of Incontinence

NCT01366066 | Terminated Phase 3

• 1 other identifier: H-2-2010-109
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Urinary Incontinence; Urge Urinary Incontinence

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Diaper test - weight (grams)

  Assesment at baseline and again after 6 weeks of treatment (when treatment is terminated)

Secondary Outcomes (5)

• 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)

• Treatment satisfaction

  After 6 weeks of treatment (when treatment is terminated)

• Urethral pressure (in the stress group)

  Assesment at baseline and again after 6 weeks of treatment (when treatment is terminated)

• Episodes of over active bladder during urodynamics (urge patients)

  Assesment at baseline and again after 6 weeks of treatment (when treatment is terminated)

• 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)

Study Arms (4)

TMNS treatment - Stress incontinence

ACTIVE COMPARATOR

Women with stress incontinence treated with active TMNS (vibration)

Device: Transcutaneous mechanical nerve stimulation

No treatment - stress incontinence

NO INTERVENTION

Women with stress incontinence NOT treated with TMNS (vibration)

TMNS treatment - Urge incontinence

ACTIVE COMPARATOR

Women with stress incontinence treated with TMNS (vibration)

Device: Transcutaneous mechanical nerve stimulation

No treatment - urge incontinence

NO INTERVENTION

Women with urge incontinence NOT treated with TMNS (vibration)

Interventions

Transcutaneous mechanical nerve stimulation 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. 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.

Also known as: FERTI CARE personel, Multicept A/S, Albertslund, Danmark

TMNS treatment - Stress incontinence; TMNS treatment - Urge incontinence

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Copenhagen University Hospital at Herlev: lead
• Zealand University Hospital: collaborator

Study Sites (1)

Departement of Gynecology, Roskilde Hospital

Roskilde, Denmark, 4000, Denmark

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress; Urinary Incontinence, Urge

Condition Hierarchy (Ancestors)

Urinary Incontinence; 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

• Mikkel Fode, MD

  Copenhagen University Hospital at Herlev

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2011
• First Posted: June 3, 2011
• Study Start: May 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: June 1, 2013
• Last Updated: May 24, 2013

Record last verified: 2013-05

Locations

DK (1)