Analgesic Effect of an Injection of Botulinum Toxin Type A in the Ganglion Impar in Patients With Chronic Proctalgia (Impartox)
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ClinicalTrials.gov Identifier: NCT01331356 |
Recruitment Status
:
Completed
First Posted
: April 8, 2011
Last Update Posted
: October 7, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Proctalgia | Drug: Botox | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 18 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | October 2010 |
Actual Primary Completion Date : | July 2012 |
Actual Study Completion Date : | July 2012 |

Arm | Intervention/treatment |
---|---|
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
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- Change from baseline in main score (SP) at 1 month [ Time Frame: 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).
- To assess the adverse events [ Time Frame: 6 month ]
- To assess the duration of action of the product (main score SP) [ Time Frame: 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 [ Time Frame: 6 month ]
- To assess the evolution of analgesics consumption [ Time Frame: 6 month ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01331356
France | |
Nantes University Hospital | |
Nantes, France, 44093 | |
Centre Catherine de Sienne | |
Nantes, France, 44200 |
Principal Investigator: | Jean-Jacques LABAT, Dr | Nantes University Hospital |
Responsible Party: | Nantes University Hospital |
ClinicalTrials.gov Identifier: | NCT01331356 History of Changes |
Other Study ID Numbers: |
10/4-T |
First Posted: | April 8, 2011 Key Record Dates |
Last Update Posted: | October 7, 2013 |
Last Verified: | October 2013 |
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 Cysts Neoplasms Mucinoses Connective Tissue Diseases Botulinum Toxins Botulinum Toxins, Type A onabotulinumtoxinA abobotulinumtoxinA 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 |