Management of Dyssynergic Defecation (NCT07225803) | Clinical Trial Compass
RecruitingNot Applicable
Management of Dyssynergic Defecation
United States200 participantsStarted 2025-07-18
Plain-language summary
The purpose of this research is to better understand constipation and improve biofeedback treatments.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
* Men and women aged 18-80 years who are able and willing to provide written informed consent and to comply with the requirements for the entire study
* Satisfy Rome III criteria for functional constipation and/or irritable bowel syndrome as assessed by questionnaires and objective evidence of dyssynergic defecation on anorectal testing
Exclusion Criteria:
* Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric or other diseases that may interfere with the objectives of the study and/or pose safety concerns.
* History of total, hemi- or subtotal colectomy at any time or other abdominal operations within 60 days prior to entry into the study. Segmental resection of the colon (e.g. sigmoid resection) for diverticulitis will be permitted.
* Current anal fissure
* Clinically significant structural abnormalities (eg, rectocele \> 4cm, large enterocele, full thickness rectal prolapse) that, in the opinion of the investigator, are likely contributing to symptoms
* Current or past history of colon or rectal cancer, scleroderma, inflammatory bowel disease, congenital anorectal abnormalities, solitary rectal ulcer syndrome, rectal resection or pelvic irradiation
* Pregnant or nursing women, prisoners and institutionalized individuals
* BMI \>35 kg/m2
* Use of opioid analgesics or GLP-1 receptor agonists. Patients on opioids will be allowed to participate if they have discontinued t…
What they're measuring
1
Change in rectoanal gradient during evacuation
Timeframe: Baseline, through study completion, an average of 16 weeks
2
Change in rectal pressure during evacuation
Timeframe: Baseline, through study completion, an average of 16 weeks
3
Change in balloon expulsion time
Timeframe: Baseline, through study completion, an average of 16 weeks
4
Change in rectal emptying time
Timeframe: Baseline, through study completion, an average of 16 weeks
5
Change in rectal emptying rate
Timeframe: Baseline, through study completion, an average of 16 weeks