Clinical trial NCT02428595: A Clinical Evaluation of the Eclipse™ System, a Vaginal Bowel Control (VBC) Therapy for Fecal Incontinence in Women
Official title: A Clinical Evaluation of the Eclipse™ System, a Vaginal Bowel Control (VBC) Therapy for Fecal Incontinence in Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fecal Incontinence
Lead sponsor: Pelvalon, Inc.
Sponsor class: INDUSTRY
First posted: 2015-04-29
Enrollment: 137
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Count of Treatment Responders in the Intent to Treat (ITT) Cohort
timeFrame: 3 months
Secondary outcomes:
measure: Count of Treatment Responders in the Per Protocol (PP) Population
timeFrame: 3, 6 and 12 months
measure: Change in St. Mark's (Vaizey) Incontinence Severity Score as Compared to Baseline
timeFrame: 12 months
measure: Change in Fecal Incontinence Quality of Life (FIQoL) Score as Compared to Baseline
timeFrame: 12 months
measure: Numbers of Participants With Specific Patient Global Impression of Improvement (PGI-I) Scores
timeFrame: 3, 6, 9 and 12 months
Other outcomes:
measure: Safety Endpoint - Number of Device Related Adverse Events
timeFrame: 3, 6, 9 and 12 months
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Boston
country: United States
facility: Massachusetts General Hospital (MGH)
state: Massachusetts
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Raleigh
country: United States
facility: University of North Carolina
state: North Carolina
city: Cincinnati
country: United States
facility: Christ Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma
state: Oklahoma
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Providence
country: United States
facility: Brown University (WIHRI)
state: Rhode Island
city: Houston
country: United States
facility: Houston Methodist
state: Texas
city: Spokane
country: United States
facility: Providence Sacred Heart
state: Washington
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Alabama at Birmingham
name: Holly Richter, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.