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

Study Overview
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Brief Summary
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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)

Official Title
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Prospective Multicenter Pilot Study Evaluating the Analgesic Effect of an Injection of Botulinum Toxin Type A in the Ganglion Impar in Patients With Chronic Proctalgia According to the Criteria of Rome III

Conditions
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Proctalgia

Intervention / Treatment
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* Drug: Botox


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Injection of botulinum toxin type A<br> | Drug: Botox<br>* One injection of botulinum toxin type A in the ganglion Impar in patients with chronic proctalgia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in main score (SP) at 1 month | 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) by calculating the main score (SP). | one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the adverse events |  | 6 month | 
| To assess the duration of action of the product (main score SP) |  | 6 month | 
| To assess the changing parameters of quality of life: global improvement score / treatment satisfaction assessed by digital scale, international pain scales (MPI, QDSA, QCD) / Beck score and Hospital Anxiety and Depression (HAD) score |  | 6 month | 
| To assess the evolution of analgesics consumption |  | 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic proctalgia, Botulinum toxin type A, Ganglion Impar, Perineal pain, Pudendal neuralgia, Refractory chronic proctalgia