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

Nantes University Hospital2 sites in 1 country18 target enrollmentOctober 2010

ConditionsProctalgia

InterventionsBotox

DrugsBotox

Overview

Phase: Phase 2
Intervention: Botox
Conditions: Proctalgia
Sponsor: Nantes University Hospital
Enrollment: 18
Locations: 2
Primary Endpoint: Change from baseline in main score (SP) at 1 month
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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)

Registry

clinicaltrials.gov

Start Date

October 2010

End Date

July 2012

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Nantes University Hospital

Responsible Party

Sponsor

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

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

Arms & Interventions

Injection of botulinum toxin type A

Intervention: Botox

Outcomes

Primary Outcomes

Change from baseline in main score (SP) at 1 month

Time Frame: one month

Secondary Outcomes

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)
To assess the evolution of analgesics consumption(6 month)