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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| InToneTM (InControl Medical, LLC) - Medical Device | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pad Test Weighting | urine voiding measure | up to 26 weeks |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dean S Elterman, MD | Contact | dean.elterman@uhn.ca |
| Name | Affiliation | Role |
|---|---|---|
| Dean S Elterman, MD | University Health Network, Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Health Network (Altum Health) | Recruiting | Toronto | Ontario | M5T 2S8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9322620 | Background | 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. doi: 10.1016/s0002-9378(97)70142-x. | |
| 12187188 | Background | 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. doi: 10.1016/S0022-5347(05)64540-5. |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014550 | Urinary Incontinence, Stress |
| D053202 | Urinary Incontinence, Urge |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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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 |
| 25408383 | Background | Dumoulin C, Hay-Smith J, Habee-Seguin 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. |
| 3493802 | Background | Eriksen BC, Bergmann S, Mjolnerod OK. Effect of anal electrostimulation with the 'Incontan' device in women with urinary incontinence. Br J Obstet Gynaecol. 1987 Feb;94(2):147-56. doi: 10.1111/j.1471-0528.1987.tb02342.x. |
| 6608590 | Background | Fall M. Does electrostimulation cure urinary incontinence? J Urol. 1984 Apr;131(4):664-7. doi: 10.1016/s0022-5347(17)50566-2. |
| 10024253 | Background | Bo 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. doi: 10.1136/bmj.318.7182.487. |
| 16399154 | Background | Norton P, Brubaker L. Urinary incontinence in women. Lancet. 2006 Jan 7;367(9504):57-67. doi: 10.1016/S0140-6736(06)67925-7. |
| 8016945 | Background | 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. Danish. |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |