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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Proctalgia

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Trial Information

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


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 120 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Change from baseline in main score (SP) at 1 month

Outcome Description:

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).

Outcome Time Frame:

one month

Safety Issue:

Yes

Principal Investigator

Jean-Jacques LABAT, Dr

Investigator Role:

Principal Investigator

Investigator Affiliation:

Nantes University Hospital

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

10/4-T

NCT ID:

NCT01331356

Start Date:

October 2010

Completion Date:

November 2011

Related Keywords:

  • Proctalgia
  • Chronic proctalgia
  • Botulinum toxin type A
  • Ganglion Impar
  • Perineal pain
  • Pudendal neuralgia
  • Refractory chronic proctalgia
  • Synovial Cyst
  • Ganglion Cysts

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