Effects of Botox in Obstructed Defecation Syndrome

Stopped early · Phase 2

Conditions studied: Obstructed Defecation Syndrome (ODS)

In brief

The purpose of this study is to determine if Botulinum Toxin-A (Botox) injection will improve symptoms of constipation in obstructed defecation syndrome (ODS).

Key facts

Study ID

NCT02160288

Run by

Massachusetts General Hospital

People needed

1

Starts

2016-02-01

Expected to finish

2019-06-11

Last updated by the study team

2020-05-12

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and females 18 years or older of all races and backgrounds
• Competent to give informed consent
• Meet the Rome III diagnostic criteria for functional constipation
• Inability to relax the puborectalis muscle at electromyography
• Altomare Obstructed Defecation Syndrome score of 15 points or above
• Failure of treatment with 2 conservative measures which may be as follows:
• 1 laxative (osmotic or stimulant) for 2 weeks
• 1 fiber supplement for one month
• And/or trial of biofeedback for at least 4 sessions

You may not qualify if…

• Previous treatment with Botox (possible antibodies)
• Known hypersensitivity to any of the components of the toxin
• Medication regimen includes narcotics
• Previous radiation therapy to the anal canal and rectum
• Prior proctectomy
• Presence of unhealed and symptomatic anal fissure
• Presence of anal pain
• Presence of fecal incontinence
• Presence of full thickness rectal prolapse
• Presence of internal sphincter myopathy
• Inflammatory bowel disease or proctitis
• Pregnancy or breast-feeding
• Subject is currently enrolled/ just finished participating in a clinical trial in which the intervention/ its carry-over effect may interact with the intervention in this trial

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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