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

Phase 2

Completed

• Conditions: Proctalgia
• Interventions: Drug: Botox

• Registration Number: NCT01331356
• Lead Sponsor: Nantes University Hospital

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2011-03-31
• Study First Submitted QC: 2011-04-06
• Study First Posted: 2011-04-08
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-04
• Last Update Posted: 2013-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Injection of botulinum toxin type A	Botox	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
To assess the evolution of analgesics consumption	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 duration of action of the product (main score SP)	6 month
To assess the adverse events	6 month

Trial Locations

Locations (2)

Centre Catherine de Sienne; 🇫🇷 Nantes, France

Nantes University Hospital; 🇫🇷 Nantes, France