Analgesic Effect of an Injection of Botulinum Toxin Type A in the Ganglion Impar in Patients With Chronic Proctalgia

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The main objective is to evaluate the analgesic efficacy of botulinum toxin type A in refractory chronic proctalgia one month after a bilateral injection of 50 units of Botox ® in the ganglion Impar (total dose = 100 units)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nantes University Hospital
• Treatments: abobotulinumtoxinA; Analgesics; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

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