Intervention for Urinary Incontinence

N/A

Waitlist Available

Led By Dean S Elterman, MD

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months follow-up

Awards & highlights

No Placebo-Only Group

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.

Eligible Conditions

Urinary Incontinence

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pad Test Weighting

Secondary study objectives

48 Hour Bladder Diary

Incontinence Impact Questionnaire Short Form (IIQ-7)

International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ UI SF)

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: InterventionExperimental Treatment1 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.

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