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 @ 7:19 PM
Ignite Modification Date:
2025-12-24 @ 7:19 PM
NCT ID:
NCT01629303
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years old
* Constipation defined by at least two of the following criteria :
* Frequency of 2 stools or less per week
* Severe outlet constipation, i.e. need to use digital extraction or enemas more than 25% of time
* Sensation of incomplete evacuation more than 25% of time
* Refractory constipation since at least 1 year to medical treatment (drug treatment and/or biofeedback) conducted in the centre (failure or intolerance to laxative osmotic treatments, stimulants, and prucalopride) for which surgery is discussed
* Patients supported in the centre for at least 3 months before inclusion
* Patients having social security system
* Patients having read and signed informed consent form
Exclusion Criteria:
* Constipation secondary to ano-rectal malformation, surgical sequel, colorectal or anal organic lesions, or pelvi-perineal static disorder indicated for surgical treatment
* Constipation secondary to neurological pathology and/or concomitant treatments intake (opiates, anticholinergic agents)
* Partial colectomy history
* Patients in whom implantation of stimulating electrode is impossible due to anatomical reasons (e.g. sacral agenesis)
* Pregnant female patients or with childbearing potential without adequate contraceptive barrier (oestrogen-progesterone contraceptives or intra-uterine device)
* Skin disease associated with a risk of infection - in the opinion of the investigator
* Patient with pacemaker or defibrillator
* Patient exposed to resonance magnetic imaging
* Psychiatric disease incompatible with use of the treatment - in the opinion of the investigator
* Patient misunderstanding oral and written French language
* Patient participating to another study
* Patients who don't complete the first diary without missing data (concerning items used to define the primary endpoint)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01629303
Study Brief:
Protocol Section:
NCT01629303