Clinical trial NCT02543242: InTone for Urinary Incontinence
Official title: Effectiveness of the Intone Pelvic Floor Device for Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urinary Incontinence
Keywords: Urinary Incontinence
Stress Urinary Incontinence
Urge Incontinence
Mixed Urinary Incontience
Female Pelvic Health
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2015-09-07
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Pad Test Weighting
timeFrame: up to 26 weeks
Secondary outcomes:
measure: Urinary Distress Inventory (UDI-6)
timeFrame: screening, Device Set up/Training Day, 2, 6, 14, 26 weeks from set up.
measure: Incontinence Impact Questionnaire Short Form (IIQ-7)
timeFrame: screening, Device Set up/Training Day, 2, 6, 14, 26 weeks from set up.
measure: Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12)
timeFrame: screening, Device Set up/Training Day, 2, 6, 14, 26 weeks from set up.
measure: Urinary Incontinence Quality of Life Scale (IQOL)
timeFrame: screening, Device Set up/Training Day, 2, 6, 14, 26 weeks from set up.
measure: International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ UI SF)
timeFrame: screening, Device Set up/Training Day, 2, 6, 14, 26 weeks from set up.
measure: 48 Hour Bladder Diary
timeFrame: up to 6 months follow-up
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network (Altum Health)
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Dean S Elterman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Fall M. Does electrostimulation cure urinary incontinence? J Urol. 1984 Apr;131(4):664-7. doi: 10.1016/s0022-5347(17)50566-2.
citation: 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.
citation: Norton P, Brubaker L. Urinary incontinence in women. Lancet. 2006 Jan 7;367(9504):57-67. doi: 10.1016/S0140-6736(06)67925-7.
citation: 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.