Effects of Type A Botulinum Toxin in Obstructed Defecation Syndrome: a Phase II Randomized, Parallel-Group, Triple-Blind, Placebo-Controlled Trial

Status: Terminated
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: No
View:

• 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

Locations
United States
Massachusetts
Massachusetts General Hospital
Boston
Time Frame
Start Date: February 2016
Completion Date: June 11, 2019
Participants
Target number of participants: 1
Treatments
Active Comparator: Botulinum Toxin-A
Patients will receive Botulinum Toxin-A (Botox) injected in the puborectalis muscle and external anal sphincter. We will use 100 units of Botox, a dose with a good safety profile that has been proven to work in previous studies performed in adults.
Placebo Comparator: Normal saline
Patients will receive normal saline (placebo) injected in the puborectalis muscle and external anal sphincter.
Sponsors
Leads: Massachusetts General Hospital

This content was sourced from clinicaltrials.gov

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