Clinical trial NCT01655498: A Clinical Evaluation of a Vaginal Bowel Control System for the Treatment of Fecal Incontinence in Women (LIFE)
Official title: A Clinical Evaluation of the LivSure Vaginal Bowel Control (VBC) System for the Treatment of Fecal Incontinence in Women.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fecal Incontinence
Keywords: fecal incontinence
bowel control
Lead sponsor: Pelvalon, Inc.
Sponsor class: INDUSTRY
First posted: 2012-08-02
Enrollment: 61
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to obtain preliminary efficacy and safety data on the use of the LivSure System (now called the "Eclipse™ System") in women with fecal incontinence.


Eligibility criteria: Inclusion Criteria:

* History of FI for at least 6 months
* 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:

* Chronic rectal, anal or pelvic pain
* 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

Primary outcomes:
measure: Frequency of FI Episodes
timeFrame: 1 Month
Secondary outcomes:
measure: Number of Incontinent Days
timeFrame: 1 Month
measure: Device-related Adverse Events
timeFrame: 1month
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Holly Richter, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.