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

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:

MedlinePlus related topics: Botox

Drug Information available for: OnabotulinumtoxinA

Genetic and Rare Diseases Information Center resources: Pudendal Neuralgia

U.S. FDA Resources

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 (Adult, Senior)
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


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:


Ganglion Cysts Synovial Cyst Cysts Neoplasms Mucinoses Connective Tissue Diseases Botulinum Toxins Botulinum Toxins, Type A AbobotulinumtoxinA OnabotulinumtoxinA IncobotulinumtoxinA	Analgesics Acetylcholine Release Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents Neuromuscular Agents

ClinicalTrials.gov processed this record on September 26, 2016

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