Effects of Botox in Obstructed Defecation Syndrome

• Status: Terminated
• Trial end date: 2019-06-11
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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