A Clinical Evaluation of the Eclipse™ System, a Vaginal Bowel Control (VBC) Therapy for Fecal Incontinence in Women (LIBERATE)

• ClinicalTrials.gov Identifier: NCT02428595
• Recruitment Status: Completed
• First Posted: April 29, 2015
• Results First Posted: September 24, 2019
• Last Update Posted: September 24, 2019
• Sponsor: Pelvalon, Inc.
• Information provided by (Responsible Party): Pelvalon, Inc.

Study Description

Brief Summary:

Multi-center, prospective, within-subject control, open label clinical trial to evaluate the durability of the safety and effectiveness of the Eclipse™ System after 3 and 12 months of use.

Condition or disease	Intervention/treatment	Phase
Fecal Incontinence	Device: Eclipse™ System	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 137 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Clinical Evaluation of the Eclipse™ System, a Vaginal Bowel Control (VBC) Therapy for Fecal Incontinence in Women
• Actual Study Start Date: May 15, 2015
• Actual Primary Completion Date: July 18, 2018
• Actual Study Completion Date: July 18, 2018

Arms and Interventions

Arm

Intervention/treatment

Experimental: Treatment; Eclipse™ System

Device: Eclipse™ System; The Eclipse System is a vaginal bowel control (VBC) therapy intended to provide bowel control for women with fecal incontinence. It is comprised of a non-surgical device placed in the vagina (referred to as the "Eclipse Insert") and a pressure-regulated pump which is used to inflate and deflate the Insert. A Sizing Kit, for use during the fitting process, and an evaluation Insert (referred to as the Trial Insert) are also part of the Eclipse System.; Other Name: Vaginal Bowel Control (VBC) Therapy

Outcome Measures

Primary Outcome Measures :

1. Count of Treatment Responders in the Intent to Treat (ITT) Cohort [ Time Frame: 3 months ]
   Count of patients with >50% reduction in the average number of FI episodes per week as compared to baseline.

Secondary Outcome Measures :

1. Count of Treatment Responders in the Per Protocol (PP) Population [ Time Frame: 3, 6 and 12 months ]
   Count of patients with >50% reduction in the average number of FI episodes per week as compared to Baseline.
2. Change in St. Mark's (Vaizey) Incontinence Severity Score as Compared to Baseline [ Time Frame: 12 months ]

   Change in mean scores on subject-reported outcomes related to symptom severity as reported by St. Mark's (Vaizey) Incontinence Severity Score.

   St. Mark's is a validated scale widely used in fecal incontinence research. The scale has a 24 point range where 0 = total fecal continence (better outcome) and 24 = total fecal incontinence (worse outcome). A reduction in the St. Mark's score is a better outcome.

3. Change in Fecal Incontinence Quality of Life (FIQoL) Score as Compared to Baseline [ Time Frame: 12 months ]

   Change in mean score (from Baseline) on subject-reported outcomes as reported by FIQoL (Fecal Incontinence Quality of Life) score.

   The FIQoL scale asks a number of Fecal Incontinence (FI) related questions. Patient responses are rated from 1 to 4 points except one question which is rated from 1 to 5 points.

   The questions fall into four subscales: lifestyle, coping/behavior, depression/self-perception and embarrassment. The score for each subscale is the average of the responses in that group. For depression/self-perception the subscale score is from 1.0 to 5.0. The other subscale scores are from 1.0 to 4.0.

   The total FIQoL score is the sum of all four subscales, ranging from 4 to 17. For each subscale and the combined score, lower values indicate worse quality of life and higher values indicate better quality of life.

   An increase in score as compared to Baseline is therefore a better outcome.

4. Numbers of Participants With Specific Patient Global Impression of Improvement (PGI-I) Scores [ Time Frame: 3, 6, 9 and 12 months ]

   The Patient Global Impression of Improvement (PGI-I) is a scale which describes the patient's perception of how their symptoms have change from Baseline.

   The scale has a range of 7 points from 1 to 7, where 1 = very much better than Baseline and 7 = very much worse than Baseline and 4 = no change from Baseline. A score below 4 is a better outcome and a score above 4 is a worse outcome, and a score of 4 is a neutral outcome.

   Note that because the patient is being asked to compare their symptoms to Baseline, no data is taken for this scale at Baseline and the score is an absolute value, not a change from a previous score.

Other Outcome Measures:

1. Safety Endpoint - Number of Device Related Adverse Events [ Time Frame: 3, 6, 9 and 12 months ]

   The number of device-related adverse events and device-related serious adverse events (related defined as probably or definitely).

   Events are classified as occurring either during fitting (the process of identifying the correct size of the device) or during treatment (defined as the time when a patient receives their long term wear device until the completion of the study).

Eligibility Criteria

• Ages Eligible for Study: 19 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

Abbreviated Inclusion Criteria:

• History of Fecal Incontinence (FI) for at least 6 months
• Subject willing and able to give written informed consent to participate in the study
• Subject can read, write and communicate fluently in English
• Subject willing and able to comply with visit schedule
• Subject is able to physically manage the insertion and removal of the Insert

Abbreviated Exclusion Criteria:

• Vaginal childbirth within the last 18 months
• Currently pregnant or planning pregnancy during the study period
• Acute infections or genito-urinary injuries that would impact comfortable device use
• Current treatment for Fecal Incontinence other than medical management
• Removal or diversion of any portion of the bowel
• Recent urogenital or colorectal surgeries
• Chronic abdominal pain in absence of diarrhea
• Chronic (>6 mos) rectal, anal or pelvic pain
• Chronic watery diarrhea, unmanageable by drugs or diet
• Inflammatory Bowel Disease (IBD) such as Chron's or Ulcerative Colitis
• Rectal prolapse (mucosal or full thickness)
• Grade III or IV hemorrhoids
• Pelvic organ prolapse beyond the plane of the hymen
• Concurrent use of intra-vaginal pessary or other device
• Anal or pelvic malignancy within last 5 years
• History of pelvic irradiation for cancer
• Other significant medical or lifestyle factors that could confound the interpretation of the primary endpoint or increase subject risk

Contacts and Locations

Locations

United States, Alabama

University of Alabama

Birmingham, Alabama, United States, 35233

United States, Massachusetts

Massachusetts General Hospital (MGH)

Boston, Massachusetts, United States, 02114

United States, New Mexico

University of New Mexico

Albuquerque, New Mexico, United States, 87131

United States, North Carolina

University of North Carolina

Raleigh, North Carolina, United States, 27607

United States, Ohio

Christ Hospital

Cincinnati, Ohio, United States, 45219

United States, Oklahoma

University of Oklahoma

Oklahoma City, Oklahoma, United States, 73104

United States, Pennsylvania

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

United States, Rhode Island

Brown University (WIHRI)

Providence, Rhode Island, United States, 02903

United States, Texas

Houston Methodist

Houston, Texas, United States, 77030

United States, Washington

Providence Sacred Heart

Spokane, Washington, United States, 99204

United States, Wisconsin

University of Wisconsin

Madison, Wisconsin, United States, 53792

Sponsors and Collaborators

Pelvalon, Inc.

Investigators

• Principal Investigator: Holly Richter, PhD, MD; University of Alabama at Birmingham

  Study Documents (Full-Text)

Documents provided by Pelvalon, Inc.:

Study Protocol  [PDF] February 9, 2017

Statistical Analysis Plan  [PDF] April 2, 2018

More Information

Additional Information:

A Vaginal Bowel-Control System for the Treatment of Fecal Incontinence (results of the LIFE Study) 

Publications:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Richter HE, Dunivan G, Brown HW, Andy U, Dyer KY, Rardin C, Muir T, McNevin S, Paquette I, Gutman RE, Quiroz L, Wu J. A 12-Month Clinical Durability of Effectiveness and Safety Evaluation of a Vaginal Bowel Control System for the Nonsurgical Treatment of Fecal Incontinence. Female Pelvic Med Reconstr Surg. 2019 Mar/Apr;25(2):113-119. doi: 10.1097/SPV.0000000000000681.

Antosh DD, High R, Brown HW, Oliphant SS, Abed H, Philip N, Grimes CL. Feasibility of prophylactic salpingectomy during vaginal hysterectomy. Am J Obstet Gynecol. 2017 Nov;217(5):605.e1-605.e5. doi: 10.1016/j.ajog.2017.07.017. Epub 2017 Jul 20.

• Responsible Party: Pelvalon, Inc.
• ClinicalTrials.gov Identifier: NCT02428595
• Other Study ID Numbers: CA005
• First Posted: April 29, 2015
• Results First Posted: September 24, 2019
• Last Update Posted: September 24, 2019
• Last Verified: August 2019

Additional relevant MeSH terms:

Fecal Incontinence; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases