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

Not Applicable

Completed

• Conditions: Fecal Incontinence

• Registration Number: NCT02428595
• Lead Sponsor: Pelvalon, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-18
• Study First Submitted QC: 2015-04-27
• Study First Posted: 2015-04-29
• Study Start: 2015-05-15
• Primary Completion: 2018-07-18
• Study Completion: 2018-07-18
• Results First Submitted: 2019-05-09
• Status Verified: 2019-08
• Results First Submitted QC: 2019-08-30
• Last Update Submitted: 2019-08-30
• Results First Posted: 2019-09-24
• Last Update Posted: 2019-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 137

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (11)

University of Alabama; 🇺🇸 Birmingham, Alabama, United States

Massachusetts General Hospital (MGH); 🇺🇸 Boston, Massachusetts, United States

University of New Mexico; 🇺🇸 Albuquerque, New Mexico, United States

University of North Carolina; 🇺🇸 Raleigh, North Carolina, United States

Christ Hospital; 🇺🇸 Cincinnati, Ohio, United States

University of Oklahoma; 🇺🇸 Oklahoma City, Oklahoma, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Brown University (WIHRI); 🇺🇸 Providence, Rhode Island, United States

Houston Methodist; 🇺🇸 Houston, Texas, United States

Providence Sacred Heart; 🇺🇸 Spokane, Washington, United States

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