Clinical trial NCT01331356: Analgesic Effect of an Injection of Botulinum Toxin Type A in the Ganglion Impar in Patients With Chronic Proctalgia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Proctalgia
Keywords: Chronic proctalgia
Botulinum toxin type A
Ganglion Impar
Perineal pain
Pudendal neuralgia
Refractory chronic proctalgia
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2011-04-08
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)


Eligibility 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

Primary outcomes:
measure: Change from baseline in main score (SP) at 1 month
timeFrame: one month
Secondary outcomes:
measure: To assess the adverse events
timeFrame: 6 month
measure: To assess the duration of action of the product (main score SP)
timeFrame: 6 month
measure: 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
timeFrame: 6 month
measure: To assess the evolution of analgesics consumption
timeFrame: 6 month
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
city: Nantes
country: France
facility: Centre Catherine de Sienne
Study officials:
affiliation: Nantes University Hospital
name: Jean-Jacques LABAT, Dr
role: PRINCIPAL_INVESTIGATOR
References: