InTone for Urinary Incontinence

Study Overview
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Brief Summary
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The rationale for the conduct of this study is that the Intone device (along with pelvic physiotherapy) can be used to help females suffering from urinary stress incontinence by using electrical stimulation and biofeedback during pelvic floor muscle training. This investigation is important because it can aid in the greater acceptance and development of non-surgical treatments for Stress Urinary Incontinence if these areas are looked into. The study results will address if the Intone device is beneficial and promotes long-term improvement in women that suffer from urinary incontinence.

Detailed Description
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Urinary incontinence is very common in women and is linked to a reduced quality of life (Corcos et al., 2002). The three main types of urinary incontinence are Stress Urinary Incontinence (SUI), Urge Urinary Incontinence (UUI) and Mixed Urinary Incontinence (MUI). SUI and UUI involve losing urine involuntarily. In SUI this is during either effortful motion such as coughing or sneezing, or in UUI is associated with a feeling of urgency. Urinary incontinence has various treatment options including: surgery, medication, pelvic floor muscle exercises and electrical stimulation (Norton & Brubaker, 2006). The most common physiotherapy treatment used for women with urinary incontinence is pelvic floor muscle training (Dumoulin & Hay-Smith, 2010). Several studies have investigated the effects of PFMT in comparison to other treatments such as no treatment and vaginal cones. They found that women in the PFMT group reported more improvement and better quality of life than women in other treatment groups. The PFMT group also had fewer daily incontinence episodes and less leakage (Bø, Talseth, & Holme, 1999; Dumoulin & Hay-Smith, 2010). Electrical stimulation of the pelvic floor muscles is another treatment for urinary incontinence, and may often be combined with PFMT. Success rates of electrical stimulation in treating urinary incontinence range from 50-90% (Bent et al., 1993; Erikson, Bergmann, & Mjølnerød, 1987; Fall, 1984; Pelvnik et al., 1986). A new product has been developed called InTone which combines PFMT, electrical stimulation and biofeedback. This device is inserted into the vagina and facilitates PFMT while providing electrical stimulation and biofeedback to the patient. This study will examine the effectiveness of the InTone device in treating urinary incontinence in women.

Official Title
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Effectiveness of the Intone Pelvic Floor Device for Urinary Incontinence

Conditions
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Urinary Incontinence

Intervention / Treatment
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* Device: InToneTM (InControl Medical, LLC) - Medical Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female gender Between ages 18-70 Diagnosed with Stress Urinary Incontinence (SUI), Urge Urinary Incontinence (UUI), or Mixed Urinary Incontinence (MUI) Exclusion Criteria: Incontinence of less than 6 months pregnancy or delivery within 6 weeks vaginal or pelvic surgery within previous 6 months pelvic organ prolapse greater than stage 2 (based on POP-Q) active UTI or history of recurrent UTIs (more than 3 in a year) recurrent vaginitis (bacterial/fungal) pelvic pain/painful bladder syndrome implanted cardiac device or untreated cardiac arrhythmi Underlying neurologic/neuromuscular disorder, or inadequate vaginal caliber (can't accommodate device).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Participants will undergo the InTone TM (InControl Medical, LLC) medical device treatment for Urinary Incontinence. The frequency of treatment is once/day (12 minutes), 5-6 days/week. The route of administration is vaginal. | Device: InToneTM (InControl Medical, LLC) - Medical Device<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pad Test Weighting | urine voiding measure | up to 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary Distress Inventory (UDI-6) | Questionnaire that assesses symptom distress and the impact on daily life of urinary incontinence | screening, Device Set up/Training Day, 2, 6, 14, 26 weeks from set up. | 
| Incontinence Impact Questionnaire Short Form (IIQ-7) | Assesses symptom distress and the impact on daily life of urinary incontinence | screening, Device Set up/Training Day, 2, 6, 14, 26 weeks from set up. | 
| Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) | Evaluates sexual function in women with pelvic organ prolapse and/or urinary incontinence. | screening, Device Set up/Training Day, 2, 6, 14, 26 weeks from set up. | 
| Urinary Incontinence Quality of Life Scale (IQOL) | A self-reported quality of life measure specific to urinary incontinence (UI), | screening, Device Set up/Training Day, 2, 6, 14, 26 weeks from set up. | 
| International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ UI SF) | A subjective measure of severity of urinary loss and quality of life for those with urinary incontinence. | screening, Device Set up/Training Day, 2, 6, 14, 26 weeks from set up. | 
| 48 Hour Bladder Diary | A diary containing details of every void. The time, amount leaked and activity during the leakage are recorded for 48 hours. | up to 6 months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urinary Incontinence, Stress Urinary Incontinence, Urge Incontinence, Mixed Urinary Incontience, Female Pelvic Health