A Clinical Evaluation of a Vaginal Bowel Control System for the Treatment of Fecal Incontinence in Women (LIFE)

Pelvalon

Status: Completed

Conditions: Fecal Incontinence

Treatments: Device: vaginal bowel control system (LivSure)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01655498

CA003

Details and patient eligibility

About

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.

Enrollment: 61 patients

Sex: Female

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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61 participants in 1 patient group

Vaginal Bowel Control

Experimental group

Description:

A vaginal bowel control system intended to manage fecal incontinence.

Treatment:

Device: vaginal bowel control system (LivSure)