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INTIBIA Therapeutic for Urological Diseases

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Urological Diseases+5 MoreINTIBIA Therapeutic - Device
Eligibility
22 - 80
All Sexes
What conditions do you have?
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Study Summary

This trial is testing a new tibial nerve stimulator to see if it is safe and effective in treating people with urgency urinary incontinence.

Eligible Conditions
  • Urinary Incontinence
  • Urological Diseases
  • Urological Symptoms
  • Urinary Bladder Disease
  • Urge Urinary Incontinence
  • Lower Urinary Tract Symptoms (LUTS)
  • Overactive Bladder

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

0 Primary · 0 Secondary · Reporting Duration: 3, 6, and 12 Months

3 Months
Surgical Satisfaction Questionnaire (SSQ-8)
Month 12
Dry
EQ-5D-5L Questionnaire
International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form
OverActive Bladder questionnaire - Short Form
Patient's Global Impression of Improvement Questionnaire
Response Rate
6 and 12 Months
Daily Voids
Urgency Score

Trial Safety

Safety Progress

1 of 3

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3
20 Botox Injections
3
OnabotulinumtoxinA 100 UNT [Botox]
3
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Trial Design

2 Treatment Groups

INTIBIA Non-Therapeutic
1 of 2
INTIBIA Therapeutic
1 of 2

Experimental Treatment

225 Total Participants · 2 Treatment Groups

Primary Treatment: INTIBIA Therapeutic · No Placebo Group · N/A

INTIBIA Non-Therapeutic
Device
Experimental Group · 1 Intervention: INTIBIA Non-Therapeutic · Intervention Types: Device
INTIBIA Therapeutic
Device
Experimental Group · 1 Intervention: INTIBIA Therapeutic · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3, 6, and 12 months

Who is running the clinical trial?

Coloplast A/SLead Sponsor
142 Previous Clinical Trials
13,062 Total Patients Enrolled
Dale KlousStudy DirectorColoplast Corp
Catherine Matthews, MDPrincipal InvestigatorWake Forest University
6 Previous Clinical Trials
447 Total Patients Enrolled

Eligibility Criteria

Age 22 - 80 · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are between 22 and 80 years of age.\n
You have symptoms of overactive bladder with urgency urinary incontinence (UUI) defined as a minimum of four (4) leaking episodes associated with urgency, and at least one leaking episode each 24-hour period.
Failure of conservative or behavioral therapy (e.g.
You are willing to abstain from OAB medications for the duration of the study.
You are willing to maintain a stable dose of all other medications that affect bladder function (e.g., tricyclic antidepressants) for at least four (4) weeks prior to the study start date.
You are willing and able to complete all procedures and follow-up visits indicated in the protocol.
References

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