InTone for Urinary Incontinence
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention 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
|
Outcome Measures
Primary Outcome Measures
- Pad Test Weighting [up to 26 weeks]
urine voiding measure
Secondary Outcome Measures
- Urinary Distress Inventory (UDI-6) [screening, Device Set up/Training Day, 2, 6, 14, 26 weeks from set up.]
Questionnaire that assesses symptom distress and the impact on daily life of urinary incontinence
- Incontinence Impact Questionnaire Short Form (IIQ-7) [screening, Device Set up/Training Day, 2, 6, 14, 26 weeks from set up.]
Assesses symptom distress and the impact on daily life of urinary incontinence
- Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) [screening, Device Set up/Training Day, 2, 6, 14, 26 weeks from set up.]
Evaluates sexual function in women with pelvic organ prolapse and/or urinary incontinence.
- Urinary Incontinence Quality of Life Scale (IQOL) [screening, Device Set up/Training Day, 2, 6, 14, 26 weeks from set up.]
A self-reported quality of life measure specific to urinary incontinence (UI),
- International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ UI SF) [screening, Device Set up/Training Day, 2, 6, 14, 26 weeks from set up.]
A subjective measure of severity of urinary loss and quality of life for those with urinary incontinence.
- 48 Hour Bladder Diary [up to 6 months follow-up]
A diary containing details of every void. The time, amount leaked and activity during the leakage are recorded for 48 hours.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Female gender
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Between ages 18-70
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Diagnosed with Stress Urinary Incontinence (SUI), Urge Urinary Incontinence (UUI), or Mixed Urinary Incontinence (MUI)
Exclusion Criteria:
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Incontinence of less than 6 months
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pregnancy or delivery within 6 weeks
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vaginal or pelvic surgery within previous 6 months
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pelvic organ prolapse greater than stage 2 (based on POP-Q)
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active UTI or history of recurrent UTIs (more than 3 in a year)
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recurrent vaginitis (bacterial/fungal)
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pelvic pain/painful bladder syndrome
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implanted cardiac device or untreated cardiac arrhythmi
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Underlying neurologic/neuromuscular disorder, or inadequate vaginal caliber (can't accommodate device).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Health Network (Altum Health) | Toronto | Ontario | Canada | M5T 2S8 |
Sponsors and Collaborators
- University Health Network, Toronto
Investigators
- Principal Investigator: Dean S Elterman, MD, University Health Network, Toronto
Study Documents (Full-Text)
None provided.More Information
Publications
- Bø K, Talseth T, Holme I. Single blind, randomised controlled trial of pelvic floor exercises, electrical stimulation, vaginal cones, and no treatment in management of genuine stress incontinence in women. BMJ. 1999 Feb 20;318(7182):487-93.
- Brubaker L, Benson JT, Bent A, Clark A, Shott S. Transvaginal electrical stimulation for female urinary incontinence. Am J Obstet Gynecol. 1997 Sep;177(3):536-40.
- Corcos J, Beaulieu S, Donovan J, Naughton M, Gotoh M; Symptom Quality of Life Assesment Committee of the First International Consultation on Incontinence. Quality of life assessment in men and women with urinary incontinence. J Urol. 2002 Sep;168(3):896-905. Review.
- Dumoulin C, Hay-Smith J, Habée-Séguin GM, Mercier J. Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women: a short version Cochrane systematic review with meta-analysis. Neurourol Urodyn. 2015 Apr;34(4):300-8. doi: 10.1002/nau.22700. Epub 2014 Nov 18. Review.
- Eriksen BC, Bergmann S, Mjølnerød OK. Effect of anal electrostimulation with the 'Incontan' device in women with urinary incontinence. Br J Obstet Gynaecol. 1987 Feb;94(2):147-56.
- Fall M. Does electrostimulation cure urinary incontinence? J Urol. 1984 Apr;131(4):664-7.
- Norton P, Brubaker L. Urinary incontinence in women. Lancet. 2006 Jan 7;367(9504):57-67. Review.
- Tjelum KB, Lose G, Abel I, Pedersen LM. [Electrostimulation of the pelvic floor muscles in urinary incontinence]. Ugeskr Laeger. 1994 Apr 11;156(15):2214-6. Review. Danish.
- InTone