Proctalgia
Conditions
Keywords
Chronic proctalgia, Botulinum toxin type A, Ganglion Impar, Perineal pain, Pudendal neuralgia, Refractory chronic proctalgia
Brief 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)
Interventions
DRUGBotox
One injection of botulinum toxin type A in the ganglion Impar in patients with chronic proctalgia
Sponsors
Nantes University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in main score (SP) at 1 month | one 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). |
Secondary
| Measure | 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 |
Countries
France
Outcome results
None listed