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 @ 11:19 PM
Ignite Modification Date:
2025-12-24 @ 11:19 PM
NCT ID:
NCT01331356
Eligibility Criteria:
Inclusion Criteria:
* Age \> 18 years
* Patient with chronic proctalgia according to the criteria of Rome III
* Chronic or recurrent rectal pain
* Pains evolve over periods of at least 20 minutes
* With the exclusion of other causes of rectal pain: ischemic, inflammatory bowel disease, cryptic lesions, intramuscular abscess, anal fissure, hemorrhoids, prostatitis and isolated coccydynia
* Pains evolve in a regular way since more than 3 months and the symptoms started since at least 6 months
* These chronic proctalgia include syndromes of anus elevator and nonspecific functional anorectal pains
* Patient with positive anesthetic block of ganglion Impar (minimum of 30 days before D0 and maximum of 270 days before D0)
* Main score (SP) ≥ 4 before infiltration of botulinum toxin type A
* Signed informed consent
* Subjects affiliated with an appropriate social security system
Exclusion Criteria:
* Pain related malignancy
* Patients with bleeding risk and recent anticoagulant therapy
* Surgery within 3 months
* Pre-existing anal incontinence
* Intolerance of botulinum toxin A, local anesthetics and radio contrast medium
* Injection of botulinum toxin in any place whatsoever in the previous 3 months
* Pregnancy and breast feeding
* Antibiotic treatment by aminoglycosides
* Recent anti-inflammatory treatment
* Severe myasthenia
* Lambert-Eaton syndrome
* Patients with neurological disorders, dysphagia, food choking or inhalation pneumonia
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01331356
Study Brief:
Protocol Section:
NCT01331356