Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2015-08-31
2016-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
InToneTM (InControl Medical, LLC) - Medical Device
Interventions
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InToneTM (InControl Medical, LLC) - Medical Device
Eligibility Criteria
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Inclusion Criteria
* Between ages 18-70
* Diagnosed with Stress Urinary Incontinence (SUI), Urge Urinary Incontinence (UUI), or Mixed Urinary Incontinence (MUI)
Exclusion Criteria
* 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).
18 Years
70 Years
FEMALE
No
Sponsors
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University Health Network, Toronto
OTHER
Responsible Party
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Principal Investigators
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Dean S Elterman, MD
Role: PRINCIPAL_INVESTIGATOR
University Health Network, Toronto
Locations
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University Health Network (Altum Health)
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
Fall M. Does electrostimulation cure urinary incontinence? J Urol. 1984 Apr;131(4):664-7. doi: 10.1016/s0022-5347(17)50566-2.
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.
Norton P, Brubaker L. Urinary incontinence in women. Lancet. 2006 Jan 7;367(9504):57-67. doi: 10.1016/S0140-6736(06)67925-7.
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.
Other Identifiers
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InTone
Identifier Type: -
Identifier Source: org_study_id
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