Transcutaneous Mechanical Nerve Stimulation in the Treatment of Incontinence

Phase 3

Terminated

• Conditions: Stress Urinary Incontinence; Urge Urinary Incontinence
• Interventions: Device: Transcutaneous mechanical nerve stimulation

• Registration Number: NCT01366066
• 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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-30
• Study First Submitted QC: 2011-06-02
• Study First Posted: 2011-06-03
• Status Verified: 2013-05
• Primary Completion: 2013-05
• Last Update Submitted: 2013-05-23
• Last Update Posted: 2013-05-24
• Study Completion: 2013-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TMNS treatment - Stress incontinence	Transcutaneous mechanical nerve stimulation	Women with stress incontinence treated with active TMNS (vibration)
TMNS treatment - Urge incontinence	Transcutaneous mechanical nerve stimulation	Women with stress incontinence treated with TMNS (vibration)

Primary Outcome Measures

Name	Time	Method
Diaper test - weight (grams)	Assesment at baseline and again after 6 weeks of treatment (when treatment is terminated)

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Departement of Gynecology, Roskilde Hospital; 🇩🇰 Roskilde, Denmark