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

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.

Study Overview

• Status: Completed
• Conditions: Fecal Incontinence
• Intervention / Treatment: Device: Eclipse™ System

• Study Type: Interventional
• Enrollment (Actual): 137
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital (MGH)
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • University of New Mexico
  • North Carolina
    • Raleigh, North Carolina, United States, 27607
      • University of North Carolina
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Christ Hospital
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Brown University (WIHRI)
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Methodist
  • Washington
    • Spokane, Washington, United States, 99204
      • Providence Sacred Heart
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Vaginal Bowel Control (VBC) Therapy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Count of Treatment Responders in the Per Protocol (PP) Population	Count of patients with >50% reduction in the average number of FI episodes per week as compared to Baseline.	3, 6 and 12 months
Change in St. Mark's (Vaizey) Incontinence Severity Score as Compared to Baseline	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.	12 months
Change in Fecal Incontinence Quality of Life (FIQoL) Score as Compared to Baseline	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.	12 months
Numbers of Participants With Specific Patient Global Impression of Improvement (PGI-I) Scores	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.	3, 6, 9 and 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Endpoint - Number of Device Related Adverse Events	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).	3, 6, 9 and 12 months

Collaborators and Investigators

• Sponsor: Pelvalon, Inc.

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2015
• Primary Completion (Actual): July 18, 2018
• Study Completion (Actual): July 18, 2018

Study Registration Dates

• First Submitted: April 18, 2015
• First Submitted That Met QC Criteria: April 27, 2015
• First Posted (Estimate): April 29, 2015

Study Record Updates

• Last Update Posted (Actual): September 24, 2019
• Last Update Submitted That Met QC Criteria: August 30, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Fecal Incontinence
• Other Study ID Numbers: CA005