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
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Change from baseline in main score (SP) at 1 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).
one month
Yes
Jean-Jacques LABAT, Dr
Principal Investigator
Nantes University Hospital
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
10/4-T
NCT01331356
October 2010
November 2011
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