InTone for Urinary Incontinence

Urinary Incontinence Clinical Trial

Official title:

Effectiveness of the Intone Pelvic Floor Device for Urinary Incontinence

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02543242
• Other study ID #: InTone
• Status: Recruiting
• Phase: N/A
• First received: September 3, 2015
• Last updated: September 4, 2015
• Start date: August 2015
• Est. completion date: September 2016

Study information

• Verified date: September 2015
• Source: University Health Network, Toronto
• Contact: Dean S Elterman, MD
• Email: dean.elterman[@]uhn.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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).

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urinary Incontinence

Intervention

Device:
• InToneTM (InControl Medical, LLC) - Medical Device

Locations

Country	Name	City	State
Canada	University Health Network (Altum Health)	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (8)

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. — View 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. — View 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. Review. — View Citation

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. — View Citation

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. — View Citation

Fall M. Does electrostimulation cure urinary incontinence? J Urol. 1984 Apr;131(4):664-7. — View Citation

Norton P, Brubaker L. Urinary incontinence in women. Lancet. 2006 Jan 7;367(9504):57-67. Review. — View 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. Review. Danish. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pad Test Weighting	urine voiding measure	up to 26 weeks	No
Secondary	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.	No
Secondary	Incontinence Impact Questionnaire Short Form (IIQ-7)	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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	No