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

Primary Purpose

Proctalgia

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Botox
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Proctalgia focused on measuring Chronic proctalgia, Botulinum toxin type A, Ganglion Impar, Perineal pain, Pudendal neuralgia, Refractory chronic proctalgia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nantes University Hospital
  • Centre Catherine de Sienne

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Injection of botulinum toxin type A

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

To assess the adverse events
To assess the duration of action of the product (main score SP)
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
To assess the evolution of analgesics consumption

Full Information

First Posted
March 31, 2011
Last Updated
October 4, 2013
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01331356
Brief Title
Analgesic Effect of an Injection of Botulinum Toxin Type A in the Ganglion Impar in Patients With Chronic Proctalgia
Acronym
Impartox
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 Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proctalgia
Keywords
Chronic proctalgia, Botulinum toxin type A, Ganglion Impar, Perineal pain, Pudendal neuralgia, Refractory chronic proctalgia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Injection of botulinum toxin type A
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Botox
Intervention Description
One injection of botulinum toxin type A in the ganglion Impar in patients with chronic proctalgia
Primary Outcome Measure Information:
Title
Change from baseline in main score (SP) at 1 month
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).
Time Frame
one month
Secondary Outcome Measure Information:
Title
To assess the adverse events
Time Frame
6 month
Title
To assess the duration of action of the product (main score SP)
Time Frame
6 month
Title
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
Title
To assess the evolution of analgesics consumption
Time Frame
6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Jacques LABAT, Dr
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nantes University Hospital
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Centre Catherine de Sienne
City
Nantes
ZIP/Postal Code
44200
Country
France

12. IPD Sharing Statement

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

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