Urinary Incontinence Clinical Trial
Official title:
Effectiveness of the Intone Pelvic Floor Device for Urinary Incontinence
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.
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.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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