A Clinical Evaluation of a Vaginal Bowel Control System for the Treatment of Fecal Incontinence in Women (LIFE)
NCT ID: NCT01655498
Last Updated: 2015-05-27
Study Results
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View full resultsBasic Information
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COMPLETED
NA
61 participants
INTERVENTIONAL
2012-08-31
2014-03-31
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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Vaginal Bowel Control
A vaginal bowel control system intended to manage fecal incontinence.
vaginal bowel control system (LivSure)
Interventions
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vaginal bowel control system (LivSure)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Baseline diary requirement for min # of FI episodes in a two-week period
* Ability to manage investigational device insertion and removal
* Successful fitting of study device
* Willing and able to give written informed consent to participate in the study
Exclusion Criteria
* Any vaginal prolapse that extends beyond the plane of the hymen.
* Previous rectal or pelvic floor surgery within the last 12 months (24 months in the case of cancer)
* Congenital anorectal malformation
* Chronic watery diarrhea unmanageable by drugs or diet as primary cause of FI
* Inflammatory bowel disease
* Presence of a vaginal, anal, rectal or urethral fistula or anastomosis
* Presence of a vaginal, rectal or bladder tumor
* Presence of an open wound or tear in the vagina or anus by exam
* Presence or history of rectovaginal fistula
* Atrophic vaginal tissue as determined by symptoms or visualization
* Current vaginal or urinary infection requiring treatment
* History of recurrent urinary or vaginal infections
* Subject is currently pregnant or planning pregnancy in next 5 months
* Concurrent use of any intra-vaginal device that would interfere with LivSure (now called Eclipse) placement or wearing
* Any significant medical condition (e.g., significant psychiatric or neurological disorders, active alcohol/drug abuse, etc.) or other factor that the investigator believes would interfere with study participation and/or increase subject risk
19 Years
75 Years
FEMALE
No
Sponsors
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Pelvalon, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Holly Richter, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Countries
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References
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Matthews CA, Varma MG, Takase-Sanchez MM, Hale DS, Van Drie D, Muir T, Wells E, Jannelli M, Richter HE. Characteristics Associated With Successful Fitting of a Vaginal Bowel Control System for Fecal Incontinence. Female Pelvic Med Reconstr Surg. 2016 Sep-Oct;22(5):359-63. doi: 10.1097/SPV.0000000000000290.
Richter HE, Matthews CA, Muir T, Takase-Sanchez MM, Hale DS, Van Drie D, Varma MG. A vaginal bowel-control system for the treatment of fecal incontinence. Obstet Gynecol. 2015 Mar;125(3):540-547. doi: 10.1097/AOG.0000000000000639.
Other Identifiers
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CA003
Identifier Type: -
Identifier Source: org_study_id
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