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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 28, 2014