InTone for Urinary Incontinence

University Health Network, Toronto

Status: Unknown

Conditions: Urinary Incontinence

Treatments: Device: InToneTM (InControl Medical, LLC) - Medical Device

Study type: Interventional

Funder types: Other

Identifiers

NCT02543242

InTone

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Intervention

Experimental group

Description:

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.

Treatment:

Device: InToneTM (InControl Medical, LLC) - Medical Device