CompletedNCT01331356ImpartoxUpdated Oct 7, 2013

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

A Phase 2 interventional study of Botox in Proctalgia, sponsored by Nantes University Hospital. Completed at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-10-07.

Sponsored by Nantes University Hospital · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 18
Allocation: Non-randomized
Ages: 18 Years and older
Sex: All

Study 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)

Conditions studied

Proctalgia

Browse trials for

Ganglion Cysts 136

Keywords

Chronic proctalgia
Botulinum toxin type A
Ganglion Impar
Perineal pain
Pudendal neuralgia
Refractory chronic proctalgia

In context

Ganglion Cysts

136 studies on the registry are indexed under Ganglion Cysts; 28 are open to participants now.

This study's enrollment of 18 is below the median of 60 across 101 interventional studies indexed under Ganglion Cysts.

Browse Ganglion Cysts studies →

Lead sponsor

Nantes University Hospital is the lead sponsor of 825 studies on the registry; 195 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: 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

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

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Single group
Masking: None (open label)
Enrollment: 18 participants (actual)

Study arms

Experimental
Injection of botulinum toxin type A
Drug: Botox

Interventions

DrugBotox
One injection of botulinum toxin type A in the ganglion Impar in patients with chronic proctalgia

What researchers measure

Primary outcomes

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).
Time frame: one month

Secondary outcomes

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

Study locations

2 sites

Nantes University Hospital
Nantes, 44093, France
Centre Catherine de Sienne
Nantes, 44200, France

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 7, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01331356
Lead sponsor: Nantes University Hospital
Responsible party: Sponsor
First posted: Apr 8, 2011
Start date: Oct 2010
Primary completion: Jul 2012
Completion: Jul 2012
Last update: Oct 7, 2013

Study contacts

Jean-Jacques LABAT, Dr

principal investigator · Nantes University Hospital

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.

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