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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01331356
First received: March 31, 2011
Last updated: October 4, 2013
Last verified: October 2013
  Purpose

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)


Condition Intervention Phase
Proctalgia
Drug: Botox
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • Change from baseline in main score (SP) at 1 month [ Time Frame: one month ] [ Designated as safety issue: Yes ]
    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:
  • To assess the adverse events [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
  • To assess the duration of action of the product (main score SP) [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • To assess the evolution of analgesics consumption [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: October 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Injection of botulinum toxin type A Drug: Botox
One injection of botulinum toxin type A in the ganglion Impar in patients with chronic proctalgia

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01331356

Locations
France
Nantes University Hospital
Nantes, France, 44093
Centre Catherine de Sienne
Nantes, France, 44200
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Jean-Jacques LABAT, Dr Nantes University Hospital
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01331356     History of Changes
Other Study ID Numbers: 10/4-T
Study First Received: March 31, 2011
Last Updated: October 4, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Nantes University Hospital:
Chronic proctalgia
Botulinum toxin type A
Ganglion Impar
Perineal pain
Pudendal neuralgia
Refractory chronic proctalgia

Additional relevant MeSH terms:
Synovial Cyst
Ganglion Cysts
Cysts
Neoplasms
Mucinoses
Connective Tissue Diseases
Analgesics
Botulinum Toxins, Type A
Botulinum Toxins
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Neuromuscular Agents
Anti-Dyskinesia Agents

ClinicalTrials.gov processed this record on April 20, 2014