UnknownNot Applicable

InTone for Urinary Incontinence

Canada30 participantsStarted 2015-08

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

What they're measuring

Pad Test Weighting

Timeframe: up to 26 weeks

Trial details

NCT IDNCT02543242

SponsorUniversity Health Network, Toronto

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-09

Contact for this trial

Dean S Elterman, MD

dean.elterman@uhn.ca

View on ClinicalTrials.gov More Urinary Incontinence trials