Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2025-12-24 @ 3:16 PM
NCT ID:
NCT02633592
Eligibility Criteria:
Inclusion Criteria:
Inclusion criteria: All
* Signed informed consent
* Male or female, age 18 - 75 years
* Females eligible to participate either if physiologically incapable of becoming pregnant or with a negative urine pregnancy test at screening
* HS: Absence of symptoms of constipation or incontinence
Patients with fecal incontinence
* Passive or Urge Incontinence
* Wexner Score of 5-20 ("more than mild severity of incontinence")
Patients with obstructive defecation
• Cleveland Clinic Constipation Scoring System: 10-30 ("more than mild severity of constipation)
Exclusion Criteria:
* • Participation in any other clinical trial with investigational or approved drugs within the last month before the study
* Significant medical, surgical or psychiatric disease requiring on-going active management
* Previous gastrointestinal or gynaecological disease (exception: non symptomatic ovarian cysts, occasional reflux, appendectomy, hysterectomy, cholecystectomy)
* Regular use of opiates or other constipating agents
* Presence of fecal impaction on clinical per rectal exam
* Abnormal findings on proctoscopy / endoscopy (e.g. Inflammatory Bowel Disease, neoplasm, acute or chronic anal fissure, large haemorrhoids (grade 3-4) intussusception, prolapse or gross perineal descent (\>5cm) on straining
* Insufficient understanding of German language to comply with instructions
* Contraindication for MRI: Presence of non-MR-compatible metallic implants, devices or metallic foreign bodies
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT02633592
Study Brief:
Protocol Section:
NCT02633592