N/A
N=137
A Clinical Evaluation of the Eclipse™ System, a Vaginal Bowel Control (VBC) Therapy for Fecal Incontinence in Women
Fecal Incontinence
Bottom Line
View on ClinicalTrials.gov: NCT02428595 ↗Enrolled (actual)
137
Serious AEs
3.8%
Results posted
Sep 2019
Primary outcome: Primary: Count of Treatment Responders in the Intent to Treat (ITT) Cohort — 53 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Eclipse™ System (Device)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- Female
- Sponsor
- Pelvalon, Inc.
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Count of Treatment Responders in the Intent to Treat (ITT) Cohort |
53 | — |
| SECONDARY Count of Treatment Responders in the Per Protocol (PP) Population |
53; 51; 51 | — |
| SECONDARY Change in St. Mark's (Vaizey) Incontinence Severity Score as Compared to Baseline |
-6.9 | — |
| SECONDARY Change in Fecal Incontinence Quality of Life (FIQoL) Score as Compared to Baseline |
0.9; 1.1; 0.7; 1.2 | — |
| SECONDARY Numbers of Participants With Specific Patient Global Impression of Improvement (PGI-I) Scores |
26; 26; 29; 29; 22; 19 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02428595). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.