Analgesic Effect of an Injection of Botulinum Toxin Type A in the Ganglion Impar in Patients With Chronic Proctalgia
NCT ID: NCT01331356
Last Updated: 2013-10-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
18 participants
INTERVENTIONAL
2010-10-31
2012-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Injection of botulinum toxin type A
Botox
One injection of botulinum toxin type A in the ganglion Impar in patients with chronic proctalgia
Interventions
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Botox
One injection of botulinum toxin type A in the ganglion Impar in patients with chronic proctalgia
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Nantes University Hospital
OTHER
Responsible Party
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Principal Investigators
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Jean-Jacques LABAT, Dr
Role: PRINCIPAL_INVESTIGATOR
Nantes University Hospital
Locations
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Nantes University Hospital
Nantes, , France
Centre Catherine de Sienne
Nantes, , France
Countries
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Other Identifiers
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10/4-T
Identifier Type: -
Identifier Source: org_study_id