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Behavioural Intervention

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

Study 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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pad Test Weighting
Secondary outcome measures
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

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.

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,466 Previous Clinical Trials
484,335 Total Patients Enrolled
Dean S Elterman, MDPrincipal InvestigatorUniversity Health Network, Toronto

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
American Journal of Obstetrics and GynecologyJournal
Transvaginal Electrical Stimulation for Female Urinary Incontinence
Brubaker, Linda, J.Thomas Benson, Alfred Bent, Amanda Clark, and Susan Shott. 1997. “Transvaginal Electrical Stimulation for Female Urinary Incontinence”. American Journal of Obstetrics and Gynecology. Elsevier BV. doi:10.1016/s0002-9378(97)70142-x.
clinicaltrials.govStudy
InTone for Urinary Incontinence
2015. "InTone for Urinary Incontinence". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02543242.
All > Urinary Incontinence
~3 spots leftby Apr 2025
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