Recruiting

InTone

Sponsor:

University Health Network, Toronto

Code:

NCT02543242

Conditions

Urinary Incontinence

Eligibility Criteria

Sex: Female

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

InToneTM (InControl Medical, LLC) - Medical Device

Study Details

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.

Conditions

Urinary Incontinence

Study ID

NCT02543242

Start date

Aug, 2015

Status verified date

Sep, 2015

Completion date

Sep, 2016

Anticipated

Primary completion date

Sep, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70

Healthy Volunteers: Not accepted

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

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

InToneTM (InControl Medical, LLC) - Medical Device

Primary outcome measure

  • Pad Test Weighting [ Time Frame: up to 26 weeks ]

Central Contacts and Locations

Central contacts

Dean S Elterman, MD

dean.elterman@uhn.ca

Locations

University Health Network (Altum Health)

Recruiting

Toronto, Ontario, Canada, M5T 2S8

Contacts

Dean Elterman, MD

dean.elterman@uhn.ca

Sara Jaffer, BSc

sara.jaffer@uhn.ca

Principal Investigator:

Dean Elterman, MD

More Information

Sponsor

University Health Network, Toronto

Last update posted

Sep 7, 2015

Last verified

Sep, 2015

Keywords

  • Urinary Incontinence
  • Stress Urinary Incontinence
  • Urge Incontinence
  • Mixed Urinary Incontience
  • Female Pelvic Health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2015-09-07.