Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Subject and Evaluator Blinded, Sham Controlled, Multicenter Study to Evaluate Efficacy and Safety of NASHA/Dx for the Treatment of Fecal Incontinence
Brief Summary: The purpose of this study is to determine the effectiveness and safety of NASHA/Dx when used as an injectable bulking agent in the treatment of fecal incontinence. The study includes a 6-month blinded sham-controlled phase, followed by an open-label phase.


Options:
A: Inclusion Criteria:

* 18 years or older
* Informed consent
* Idiopathic fecal incontinence or Fecal incontinence due to small sphincter defect(≤60 o)
* fecal incontinence after primary/secondary sphincter repair
* Permanent neuromodulator (medtronic InterStim / Interstim II) implanted for at least 12 weeks before entering the study.
* Reduction in fecal incontinence episodes of at least 75% between baseline and latest follow up.(Bowel diary card) or 75% reduction of Wexner Inc. score.
* Willing and competent to fill out diary cards

Exclusion Criteria:

* Colorectal/proctological surgery since IPG-implant
* Pregnancy
* Anorectal Pain
B: Inclusion Criteria:

* 1. Male and non-pregnant, non breast-feeding female outpatients at least 18 years of age (no upper age limit).
* 2. History of constipation; the subject reports, on average, two or fewer spontaneous bowel movements per week that result in a feeling of complete evacuation and or one or more of the following for at least 6 months before the selection visit:

  1. very hard (little balls) and/or hard stools at least a quarter of the stools
  2. sensation of incomplete evacuation following at least a quarter of the stools
  3. straining at defecation at least a quarter of the time. The above criteria are only applicable for spontaneous bowel movements, i.e., not preceded within a period of 24 hours by the intake of a laxative agent or by the use of an enema.

Subjects who never have spontaneous bowel movements are considered to be constipated and are eligible for the trial.

Exclusion Criteria:

* 1. Subjects in whom constipation is thought to be drug-induced, or subjects using any disallowed medication.
* 2. Subjects suffering from endocrine disorders, metabolic disorders or neurologic disorders.
* 3. Subjects with a megacolon/megarectum or a diagnosis of pseudo-obstruction.
* 4. Constipation as a result of surgery.
* 5. Known or suspected organic disorders of the large bowel, i.e. obstruction, carcinoma, or inflammatory bowel disease.
* 6. Subjects with severe and clinically uncontrolled cardiovascular, liver, or lung disease, neurologic or psychiatric disorders (including active alcohol or drug abuse), cancer or AIDS, and other gastrointestinal or endocrine disorders.
* 7. Subjects with impaired renal function.
* 8. Subjects with clinically significant abnormalities of haematology, urinalysis, or blood chemistry.
* 9. Females of child-bearing potential without adequate contraceptive protection during the trial.
C: 140 patients (7 study groups, up to 20 implanted patients per study group)

Fecal Incontinence groups:

Main Inclusion Criteria:

* Fecal incontinence (defined as incontinence to solid or liquid stool \> 1 / week);
* Failed biofeedback or medical therapy;

Groups 1 - 5 patients with:

* Group 1) Circumferentially intact external anal sphincter, no previous surgery;
* Group 2) Circumferentially intact external anal sphincter after surgical repair;
* Group 3) Rectal prolapse repaired with a rectopexy;
* Group 4) Spinal injury including disc prolapse;
* Group 5) Sigmoid or partial rectal resection with colorectal or coloanal anastomosis

Constipation groups:

Main Inclusion Criteria:

* Chronic constipation (defined as \</= 2 weekly bowel movements; and/or \>25% of bowel movements required straining; and/or \>25% of bowel movements patient did not feel empty afterwards) with symptoms more than 1 year
* Failed biofeedback or medical therapy;

Groups 6 - 7 patients with:

* Group 6) Idiopathic slow transit constipation as proven on colonic transit studies;
* Group 7) Normal colonic transit studies but chronic constipation due to either pelvic floor dysfunction or disordered defecation.
D: Inclusion Criteria:

* 18-75 years of age, male or female.
* Screening fecal incontinence severity score (CCFIS).
* Fecal incontinence episodes over a 14-day period.
* Failed conservative treatment for fecal incontinence.

Exclusion Criteria:

* Complete external sphincter disruption.
* Significant anorectal disease.
* Anorectal surgery within the last 12 months prior to the study.
* Active Inflammatory Bowel Disease (IBD).
* Immunodeficiency or receiving immunosuppressive therapy.
* Malignancies in remission for less than 2 years prior to the study.
* Bleeding disorders or receiving anticoagulant therapy.
* Chemotherapy within the last 12 months prior to the study.
* Prior Pelvic radiotherapy.
* Women who are pregnant or breast-feeding, or women of childbearing potential not practicing adequate contraception or planning to stop such contraception within the first year of the study.
* Women within one year post partum.
* Participation in any other clinical study within 3 month prior to the study.
* Hypersensitivity to hyaluronic acid containing products.
* Other severe conditions or in other ways unsuitable to participate according to investigator judgement.

Answer: D