InTone for Urinary Incontinence

September 4, 2015 updated by: University Health Network, Toronto

Effectiveness of the Intone Pelvic Floor Device for Urinary Incontinence

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
        • Recruiting
        • University Health Network (Altum Health)
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dean Elterman, MD
        • Sub-Investigator:
          • Rajiv Gandhi, MD
        • Sub-Investigator:
          • Sidney Radomski, MD
        • Sub-Investigator:
          • Magdy Hassouna, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pad Test Weighting
Time Frame: up to 26 weeks
urine voiding measure
up to 26 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urinary Distress Inventory (UDI-6)
Time Frame: 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
screening, Device Set up/Training Day, 2, 6, 14, 26 weeks from set up.
Incontinence Impact Questionnaire Short Form (IIQ-7)
Time Frame: 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
screening, Device Set up/Training Day, 2, 6, 14, 26 weeks from set up.
Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12)
Time Frame: 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.
screening, Device Set up/Training Day, 2, 6, 14, 26 weeks from set up.
Urinary Incontinence Quality of Life Scale (IQOL)
Time Frame: 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),
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)
Time Frame: 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.
screening, Device Set up/Training Day, 2, 6, 14, 26 weeks from set up.
48 Hour Bladder Diary
Time Frame: 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.
up to 6 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Dean S Elterman, MD, University Health Network, Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Anticipated)

September 1, 2016

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

September 3, 2015

First Submitted That Met QC Criteria

September 4, 2015

First Posted (Estimate)

September 7, 2015

Study Record Updates

Last Update Posted (Estimate)

September 7, 2015

Last Update Submitted That Met QC Criteria

September 4, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • InTone

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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