Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
99 participants
INTERVENTIONAL
2018-08-08
2019-07-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Active Treatment
Treatment dose
Viveve Treatment
The Viveve system is a monopolar radiofrequency system that uses surface cooling and radiofrequency (RF) energy delivery to provide a non-surgical and minimally-invasive approach to generate heat within the submucosal layers of vaginal tissue while keeping the surface cool.
Sham Treatment
Sub-therapeutic dose
Viveve Treatment
The Viveve system is a monopolar radiofrequency system that uses surface cooling and radiofrequency (RF) energy delivery to provide a non-surgical and minimally-invasive approach to generate heat within the submucosal layers of vaginal tissue while keeping the surface cool.
Interventions
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Viveve Treatment
The Viveve system is a monopolar radiofrequency system that uses surface cooling and radiofrequency (RF) energy delivery to provide a non-surgical and minimally-invasive approach to generate heat within the submucosal layers of vaginal tissue while keeping the surface cool.
Eligibility Criteria
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Inclusion Criteria
* Pre-menopausal females
* Documented diagnosis of SUI
Exclusion Criteria
* Undergone other SUI treatments (excluding Kegels)
18 Years
FEMALE
No
Sponsors
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Viveve Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Stacie Bell, PhD
Role: STUDY_DIRECTOR
Viveve Inc.
Locations
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LIBERATE In't Site
Vancouver, British Columbia, Canada
LIBERATE Int'l Site
Pointe-Claire, Montreal, Canada
LIBERATE Int'l Site
Burlington, Ontario, Canada
LIBERATE Int'l Site
London, Ontario, Canada
LIBERATE Int'l Site
Sarnia, Ontario, Canada
LIBERATE Int'l Site
Toronto, Ontario, Canada
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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LIBERATE International
Identifier Type: -
Identifier Source: org_study_id
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