Fecal IncontinenceLIFENCT01655498

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

A study of Fecal Incontinence, run by Pelvalon, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 19 to 75 years, women only
Conditions the study is for: Fecal Incontinence
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 61 participants
Where: 1 siteUnited States
Study dates: Aug 2012to Mar 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 to 75 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 16Show fewer

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 locations and contacts

1 site in 1 country.

United States1 site

University of Alabama at Birmingham
Birmingham, Alabama, 35249

Other trials in United States

About this study

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

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.

Conditions: Fecal Incontinence
Being tested: vaginal bowel control system (LivSure)
Keywords: fecal incontinence, bowel control
Medical subject headings: Fecal Incontinence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

vaginal bowel control system (LivSure)Device
Also called LivSure System, Eclipse™ System

Study groups in NCT01655498
Study group	Role	What they receive
Vaginal Bowel Control	Experimental	A vaginal bowel control system intended to manage fecal incontinence. Receives: Device: vaginal bowel control system (LivSure)

What is being measured

The primary outcome is the main question the study is designed to answer.

Frequency of FI Episodes
Subjects with at least a 50% reduction in FI episodes (major or minor soiling)
Measured: 1 Month

Secondary outcomes (2)

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
Measured: 1 Month
Device-related Adverse Events
The number of overall adverse events rated as probably or definitely related to the study device.
Measured: 1month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2012Mar 2014

First posted2 Aug 2012 (estimated)
Study startAug 2012
Primary completionJan 2014
Study completionMar 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Fecal IncontinenceStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 61 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01655498
Sponsor's protocol ID: CA003
Acronym: LIFE
Status last verified: May 2015
First submitted: 24 Jul 2012
Last updated: 27 May 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 27564386
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.
PubMed 25730213

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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At-Home Genital Nerve Stimulation for SCI Bowel
Spinal Cord Injury
Recruiting
Postpartum Health Trajectories the First Year After Obstetric Anal Sphincter Injury and the Impact of a Group-Based Intervention
Obstetric Anal Sphincter Injury
Recruiting
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic Constipation

All Fecal Incontinence trials

Study at a glance

From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Clinical Evaluation of the LivSure Vaginal Bowel Control (VBC) System for the Treatment of Fecal Incontinence in Women.
ClinicalTrials.gov ID: NCT01655498
Acronym / sponsor ID: LIFE / CA003
Conditions: Fecal Incontinence
Keywords: fecal incontinence, bowel control
Study type: Interventional
Recruitment status: Completed
Enrolment: 61 participants (actual)
Lead sponsor: Pelvalon, Inc.Industry (pharma, biotech, devices)
Study start: Aug 2012
Primary completion: Jan 2014 (actual)
Study completion: Mar 2014 (actual)
First posted: 2 Aug 2012 (estimated)
Results: Posted 27 May 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Vaginal Bowel Control	Experimental	Device: vaginal bowel control system (LivSure)A vaginal bowel control system intended to manage fecal incontinence.

Who may qualify

Ages: 19 to 75 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (16 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
vaginal bowel control system (LivSure)Also: LivSure System, Eclipse™ System	Device	Vaginal Bowel Control

Primary outcome

Frequency of FI Episodes
Time frame: 1 Month
Subjects with at least a 50% reduction in FI episodes (major or minor soiling)

2 secondary outcomes

Number of Incontinent Days
Time frame: 1 Month
Device-related Adverse Events
Time frame: 1month

Results and safety

Results posted to the registry on 27 May 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Subjects	61	56

Primary outcome: Frequency of FI Episodes

Time frame: 1 Month. Number. Unit: percentage of participants

Measure	Subjects Fit With the VBC Device [ITT] n = 61	Subject Fit With the VBC Device [PP] n = 56
Value	79	86

Population analysed: Subjects who were successfully fit with the VBC device.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 month Treatment Period. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ITT Cohort [N=61]	1 of 61 (1.6%)	36 of 61 (59%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27564386Matthews 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.
Derived from this study: PubMed 25730213Richter 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.

Related trials for Fecal Incontinence

Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Recruiting
Acute Genital Nerve Stimulation for Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury
Fecal Incontinence
Recruiting
At-Home Genital Nerve Stimulation for SCI Bowel
Spinal Cord Injury
Recruiting
Postpartum Health Trajectories the First Year After Obstetric Anal Sphincter Injury and the Impact of a Group-Based Intervention
Obstetric Anal Sphincter Injury
Recruiting
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic Constipation

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Holly Richter, PhD, MD principal investigator

University of Alabama at Birmingham

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study of Fecal Incontinence, run by Pelvalon, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of FI Episodes (time frame: 1 Month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01655498, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2015.