RecruitingPhase 4NCT07226739

Comprehensive Toileting Program

Comprehensive Toileting Programming: Enuresis Treatment to a Randomized Clinical Trial of a Caregiver-Mediated Multidisciplinary Intervention for Encopresis


Sponsor

Emory University

Enrollment

150 participants

Start Date

Jun 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The current study aims to monitor fecal continence after autistic youth complete enuresis treatment and for individuals who continue to experience encopresis after acquiring urine continence, evaluate a caregiver-mediated version of a Multidisciplinary Intervention for Encopresis (CM-MIE) delivered via telehealth to determine efficacy in a randomized clinical trial.


Eligibility

Min Age: 5 YearsMax Age: 12 Years

Inclusion Criteria5

  • Age 5 to 12
  • Diagnosis of an intellectual or developmental delay (excluding individuals with ADHD alone)
  • Encopresis (more than 1 incontinent BM a week)
  • Required for pre-randomization phase only: Enuresis (> 1 incontinent urination per day when on a consistent toileting sit schedule)
  • At least one caregiver who speaks and understands English

Exclusion Criteria4

  • Unresolved medical condition that would impede toilet training (e.g., interference with sphincter control, short gut syndrome, urinary tract or gastrointestinal infection, unexplained diarrhea, recent intestinal surgery, inflammatory bowel disease)
  • Failed intensive toileting treatment in the past 2 yrs with protocols akin to study
  • Current serious behavioral or psychiatric disorder that requires another treatment
  • Current or planned other intervention (behavioral or medical) for incontinence

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Interventions

DRUGGlycerin Suppository

Liquid glycerin suppositories, pediatric (age 2-5 years: 4 ml/applicator) or adult (6-12 years: 7.5ml/applicator) dose used as indicated based on age will be used in the study. Up to two doses will be delivered a day. The purpose of the glycerin suppository is to rapidly evoke a bowel movement, which allows for a predictable bowel movement to occur while the child is seated on the toilet (a continent bowel movement).

BEHAVIORALBehavioral strategies

The BCBA will provide recommendations on promoting bowel movement continence. The caregiver will be asked to collect data between visits that will be reviewed by the therapist.


Locations(1)

Marcus Autism Center

Atlanta, Georgia, United States

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NCT07226739


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