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

Nantes University Hospital (NUH)

Status and phase: Completed; Phase 2

Conditions: Proctalgia

Treatments: Drug: Botox

Study type: Interventional

Funder types: Other

Identifiers

NCT01331356

10/4-T

Details and patient eligibility

About

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)

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Injection of botulinum toxin type A

Experimental group

Treatment:

Drug: Botox