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

Fecal Incontinence Clinical Trial

— LIFE  

Official title:

A Clinical Evaluation of the LivSure Vaginal Bowel Control (VBC) System for the Treatment of Fecal Incontinence in Women.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01655498
• Other study ID #: CA003
• Status: Completed
• Phase: N/A
• First received: July 24, 2012
• Last updated: May 22, 2015
• Start date: August 2012
• Est. completion date: March 2014

Study information

• Verified date: May 2015
• Source: Pelvalon, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: March 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fecal Incontinence

Intervention

Device:
• vaginal bowel control system (LivSure)

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
Pelvalon, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of FI Episodes	Subjects with at least a 50% reduction in FI episodes (major or minor soiling)	1 Month	No
Secondary	Number of Incontinent Days	Change in number of incontinent days while wearing the device during the 2-week assessment period as compared to the baseline 2-week assessment period	1 Month	No
Secondary	Device-related Adverse Events	The number of overall adverse events rated as probably or definitely related to the study device.	1month	Yes