Effects of Botox in Obstructed Defecation Syndrome

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2019-06-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Biofeedback Therapy Versus Botox Injection in Treatment of Dyssynergic Defecation.

NCT06724250

Obstructed Defaecation Syndrome

COMPLETED PHASE4

Botox for the Treatment of Overactive Bladder Secondary to Benign Prostatic Obstruction

NCT01220726

Overactive Bladder

COMPLETED PHASE3

Infracoccygeal Botox for Dyssynergia

NCT04879524

Dyssynergic Defaecation Evacuation Disorder Anismus +1 more

COMPLETED

Effect and Tolerance of Botulinum A Toxin Rectal Injections on Fecal Incontinence

NCT02414425

Fecal Incontinence

COMPLETED PHASE3

Refractory Overactive Bladder: Sacral NEuromodulation v. BoTulinum Toxin Assessment (ROSETTA)

NCT01502956

Urinary Incontinence, Urge

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Constipation represents one of the five most common physician diagnoses for gut disorders. Obstructed defecation syndrome (ODS) is an under-treated condition which accounts for 30%- 50% of all patients with constipation and it is more common as people age. ODS is due to the abnormal contraction of the puborectalis muscle (a muscle around the anus that should relax during defecation).

Biofeedback therapy and medical management are the standards of care for ODS. Typically patients are first managed with dietary modifications (fiber supplementation, increased fluids) and medication (laxatives, enemas). If constipation is not improved, they will undergo biofeedback, which lasts from 3-8 sessions on average. Biofeedback acts on the cause of ODS and it has good short-term success, but around 50%-70% of treated patients re-experience constipation after one year. The main drawbacks of biofeedback for ODS are the facts that it is expensive, time-consuming, available in few select-centers and its success depends very much on the provider. Biofeedback is delivered in multiple 1-hour clinic sessions, so many patients don't finish all recommended sessions and their constipation may recur faster.

Botox also acts on the cause of ODS and was shown to improve constipation within 1-3 weeks after the injection. Botox is delivered as a one-time injection in the puborectalis muscle and external anal sphincter (the muscle right around the anus). The injection can be performed in the clinic under local anesthesia, and the patient goes home afterwards. Currently, Botox is used for treatment of patients who fail biofeedback and medical management, to avoid the options of last resort (resection of the colon with stoma). To this day, no adequately designed study has confirmed that Botox is indeed superior to placebo (normal saline) for the treatment of ODS. The results from this study will provide valuable data on the ability of Botox to improve symptoms of constipation and the duration of its effect. This project has the potential to increase the availability of effective treatments for ODS.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obstructed Defecation Syndrome (ODS)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Botulinum Toxin-A

Intervention Type DRUG

100 Units diluted in a 5 cc syringe at a concentration of 20U/mL

Normal saline

Patients will receive normal saline (placebo) injected in the puborectalis muscle and external anal sphincter.

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type DRUG

Dispensed in a 5 cc syringe

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Botulinum Toxin-A

100 Units diluted in a 5 cc syringe at a concentration of 20U/mL

Intervention Type DRUG

Normal Saline

Dispensed in a 5 cc syringe

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Botox 0.9% Sodium Chloride

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No