A Clinical Evaluation of a Vaginal Bowel Control System for the Treatment of Fecal Incontinence in Women (LIFE) (LIFE)
This study has been completed.
Sponsor:
Pelvalon, Inc.
Information provided by (Responsible Party):
Pelvalon, Inc.
ClinicalTrials.gov Identifier:
NCT01655498
First received: July 24, 2012
Last updated: May 22, 2015
Last verified: May 2015
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Fecal Incontinence |
Device: vaginal bowel control system (LivSure) |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Clinical Evaluation of the LivSure Vaginal Bowel Control (VBC) System for the Treatment of Fecal Incontinence in Women. |
Resource links provided by NLM:
Further study details as provided by Pelvalon, Inc.:
Primary Outcome Measures:
- Frequency of FI Episodes [ Time Frame: 1 Month ] [ Designated as safety issue: No ]Subjects with at least a 50% reduction in FI episodes (major or minor soiling)
Secondary Outcome Measures:
- Number of Incontinent Days [ Time Frame: 1 Month ] [ Designated as safety issue: No ]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
- Device-related Adverse Events [ Time Frame: 1month ] [ Designated as safety issue: Yes ]The number of overall adverse events rated as probably or definitely related to the study device.
| Enrollment: | 61 |
| Study Start Date: | August 2012 |
| Study Completion Date: | March 2014 |
| Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Vaginal Bowel Control
A vaginal bowel control system intended to manage fecal incontinence.
|
Device: vaginal bowel control system (LivSure)
Other Names:
|
Eligibility| Ages Eligible for Study: | 19 Years to 75 Years (Adult, Senior) |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01655498
Please refer to this study by its ClinicalTrials.gov identifier: NCT01655498
Locations
| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35249 | |
Sponsors and Collaborators
Pelvalon, Inc.
Investigators
| Principal Investigator: | Holly Richter, PhD, MD | University of Alabama at Birmingham |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Pelvalon, Inc. |
| ClinicalTrials.gov Identifier: | NCT01655498 History of Changes |
| Other Study ID Numbers: | CA003 |
| Study First Received: | July 24, 2012 |
| Results First Received: | April 1, 2015 |
| Last Updated: | May 22, 2015 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pelvalon, Inc.:
|
fecal incontinence bowel control |
Additional relevant MeSH terms:
|
Fecal Incontinence Rectal Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on September 30, 2016