Please select the eligibility criteria that correspond to the clinical trial below.
Title: Dose Response Curve - Sacral Nerve Stimulation for Faecal Incontinence
Brief Summary: The purpose of this study is to determine if subsensory stimulation (amplitude) will maintain same continence in patients treated with Sacral Nerve Stimulation (SNS) for faecal incontinence as stimulation with amplitude at sensory threshold.


Options:
A: 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.
B: 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.
C: 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.
D: 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

Answer: D