A Pilot Clinical Study of the Efficacy and Safety of a Disposable Intravaginal Device for Stress Urinary Incontinence
NCT ID: NCT01762345
Last Updated: 2016-03-24
Study Results
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View full resultsBasic Information
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COMPLETED
NA
148 participants
INTERVENTIONAL
2012-12-31
2013-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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pessary device
pessary (disposable intra-vaginal device)
pessary (disposable intra-vaginal device)
pessary device(disposable intra-vaginal device)manufactured by Procter \& Gamble
Interventions
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pessary (disposable intra-vaginal device)
pessary device(disposable intra-vaginal device)manufactured by Procter \& Gamble
Eligibility Criteria
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Inclusion Criteria
* be willing to use the pessary investigational device to control stress incontinence
Exclusion Criteria
* within 3 months post partum
* intrauterine device (IUD) placement of less than 6 months
* a history of Toxic Shock Syndrome (TSS) or symptoms consistent with TSS
* experience difficulty inserting or wearing an intra-vaginal device, including a tampon
* vaginal surgery, perineal surgery, uterine surgery, or abortion (spontaneous or induced) within the past 3 months
* has any Screening laboratory value outside the laboratory reference range considered clinically significant by the Investigator
* for any reason, the Investigator decides that the subject should not participate in the study
18 Years
FEMALE
No
Sponsors
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Procter and Gamble
INDUSTRY
Responsible Party
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Principal Investigators
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Randall Severance, MD
Role: PRINCIPAL_INVESTIGATOR
Radiant Research, Inc.
Locations
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Study Center
Chandler, Arizona, United States
Countries
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Other Identifiers
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2012099
Identifier Type: -
Identifier Source: org_study_id
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