Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Clinical Evaluation of the Eclipse™ System, a Vaginal Bowel Control (VBC) Therapy for Fecal Incontinence in Women
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.


Options:
A: 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
B: Inclusion Criteria:

* Women ages 18-45 scheduled for laparoscopic hysterectomy with planned preservation of both ovaries.

Exclusion Criteria:

* Carrier for the gene that codes for breast cancer type 1 susceptibility protein (BRCA1) or the gene that codes for breast cancer type 2 susceptibility protein (BRCA 2).
* Personal history of gynecologic cancer
* Pregnancy
* Non-English speaking
* Unable to provide informed consent
C: Inclusion Criteria:

* Female patient has primary symptoms of SUI, as confirmed by patient medical history and clinical symptoms, including a focused incontinence evaluation.

Exclusion Criteria:

* Patient has symptoms of pure urge incontinence as confirmed by basic evaluation of etiology from a patient medical history, including a focused incontinence history.
* Patient has symptoms of mixed urinary incontinence where urge incontinence is the predominant factor.
* Patient has had stress urinary incontinence symptoms less than 6 months prior to signing the informed consent.
* Patient has not previously attempted conservative treatment prior to signing the informed consent. (Examples of conservative treatment include behavior modifications, bladder exercises, biofeedback, etc.)
* Patient has more than 2 episode of awakening to void during normal sleeping hours.
* Patient cannot be maintained on a stable dose and/or frequency of medication (including diuretics) known to affect lower urinary tract function, including but not limited to, anticholinergics, tricyclic antidepressants or alpha-adrenergic blockers, for at least 2 weeks prior to screening or is likely to change during the course of the study.
* Patient is pregnant, lactating, or plans to become pregnant during the course of the study.
* Patient refuses to provide written informed consent.
* Patient is not at least 18 years of age.
* Patient is not available for the follow-up evaluations as required by the protocol.
D: Inclusion Criteria:

* Premenopausal women with a documented BRCA1 and/or BRCA2 germline mutation
* Age 25-40 years for BRCA1 mutation carriers, 25-45 years for BRCA2
* Childbearing completed
* Presence of at least one fallopian tube
* Participants may have a personal history of non-ovarian malignancy

Exclusion Criteria:

* Postmenopausal status (natural menopause or due to (cancer) treatment)
* Wish for second stage oophorectomy within two years after salpingectomy (if clear at enrollment)
* Legally incapable
* Prior bilateral salpingectomy
* A personal history of ovarian, fallopian tube or peritoneal cancer
* Evidence of malignant disease at enrollment
* Treatment for malignant disease at enrollment
* Inability to read or speak Dutch

BRCA mutation carriers who opt for salpingectomy but who do not want to postpone the oophorectomy beyond the guideline age will undergo similar follow-up but do not contribute to the 510 inclusions we need

Answer: A